Worst Pills, Best Pills

An expert, independent second opinion on more than 1,800 prescription drugs, over-the-counter medications, and supplements

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DISEASE AND DRUG FAMILY INFORMATION
Misprescribing and Overprescribing of Drugs
The numbers are staggering: in 2003, an estimated 3.4 billion prescriptions were filled in retail drugstores and by mail order in the United States. That averages out to 11.7 prescriptions filled for each of the 290 million people in this country. But many people do not get any prescriptions filled in a given year, so it is also important to find out how many prescriptions are filled by those who fill one or more prescriptions. In a study based on data from 2000, more than twice as many prescriptions were filled for those 65 and older (23.5 prescriptions per year) than for those younger than 65 (10.1 prescriptions per year).
Adverse Drug Reactions
Although some adverse drug reactions (ADR) are not very serious, others cause the death, hospitalization, or serious injury of more than 2 million people in the United States each year, including more than 100,000 fatalities. In fact, adverse drug reactions are one of the leading causes of death in the United States. Most of the time, these dangerous events could and should have been avoided. Even the less drastic reactions, such as change in mood, loss of appetite, and nausea, may seriously diminish the quality of life.
Drug-Induced Diseases
Each year, more than 9.6 million adverse drug reactions occur in older Americans. The referenced study found that 37% of these adverse reactions were not reported to the doctor, presumably because patients did not realize the reactions were due to the drug. This is not too surprising considering that most doctors admitted they did not explain possible adverse effects to their patients.
Diet Drugs
The FDA has set the bar too low for the approval of diet drugs. Instead of requiring that diet drugs be proved to prevent the long term consequences of obesity (none ever has), diet drugs can be approved if they show a modest weight loss over a relatively short period.
Oral Contraceptives
The pill can cause many adverse effects. Some of them are merely a nuisance, while others can be life-threatening. The pill can cause headaches, bloating, nausea, irregular bleeding and spotting, breast tenderness, weight gain, or vision changes. Other more serious adverse effects that can occur from a few months to a few years after starting oral contraceptives include high blood pressure, gallbladder disease, liver tumors, depression, and metabolic disorders, such as diabetes. Temporary infertility has been associated with the period of time right after pill use is stopped. But the two most dangerous risks associated with taking birth control pills are blood clots and cancer.
Migraine Headaches
For reasons of both safety and cost, the newer migraine drugs known as triptans should be used only after determining that the NSAIDs and acetaminophen fail to work. The triptans can dangerously, even fatally, narrow arteries in the heart.
Thyroid Hormone
Variations in the amount of active levothyroxine available in a tablet can affect both the safety and effectiveness of the drug. Levothyroxine is unstable in the presence of light, temperature, air, and humidity. Patients who receive superpotent tablets (too much levothyroxine) experience chest pain, rapid heart rate, or heart rhythm disturbances. There is also evidence that overtreatment can cause the bone-weakening disease osteoporosis. Subpotent (too little levothyroxine) tablets will not be effective in controlling the symptoms of low thyroid hormone production (hypothyroid).
Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder
To correctly establish the diagnosis of ADHD requires the use not only of medical but also of special psychological, educational, and social resources. Many children diagnosed with ADHD actually have problems that are primarily caused or worsened by inadequate teachers, unsuitable educational settings, or by problems with their parents. Similarly, many adults diagnosed with ADHD may have interpersonal problems that need to be dealt with by psychotherapy.
Diabetes Prevention and Treatment
Diets that are very complicated or very different from what you are used to are hard to follow. The American Diabetes Association (ADA) diet is a highly structured plan based on exchange lists. Although it serves its purpose of regulating calorie and sugar intake quite well, the ADA diet may be difficult for older people to use. Successful use of this diet requires considerable time spent planning meal patterns and food portions. Older people often have trouble with this diet because the food lists are long and complicated and require considerable memorization.
Muscle Relaxants
Some of the widely prescribed muscle relaxants covered on this web site have been on the market for more than 40 years. Yet five of these drugs were among the top 200 most frequently prescribed medications in the United States in 2002, with more than 30 million prescriptions dispensed. Since their original marketing, there has been very little reliable evidence that these drugs actually relax muscles.
Benign Prostatic Hypertrophy (BPH)
If your BPH symptoms are minimal, no treatment is necessary, no matter what the size of your prostate gland. If you have BPH symptoms and do not have a very enlarged gland, then an alpha-blocker such as terazosin would be the best choice. If your prostate is very enlarged, treatment with an alpha-blocker would again be the best choice. Finasteride should be used only if an alpha-blocker failed to relieve your symptoms.
Osteoporosis
Osteoporosis is a reduction in bone mass and weakening of bone architecture that increases the susceptibility of bone to fracture. Bone is a living tissue that is constantly being broken down and resynthesized at 1 to 2 million microscopic sites in the adult skeleton. Osteoporosis occurs when the rate of breakdown is faster than the rate of resynthesis. The history of the treatment or prevention of osteoporosis is strewn with drugs such as estrogens—discussed below—and others in this chapter with marginal effectiveness or with risks clearly outweighing the benefits.
Hormone Replacement Therapy
In 1991, the Health Research Group published the Women’s Health Alert. The largest chapter in the book was on hormone replacement therapy (HRT). By then, the evidence was clear that these drugs caused breast cancer, and very serious doubts had been raised about their ability to protect against heart disease. The first sentence in this chapter began: Female replacement hormones may someday be remembered as the most recklessly prescribed and dangerous drugs of this century.
Smoking Cessation
There is no question that smoking involves a physical addiction to nicotine as well as psychological addiction to the patterns of smoking in certain circumstances or situations. Unless attention is paid to both of these kinds of addiction, the chance of success in stopping smoking will not be as good as it could be.
Erectile Dysfunction
A number of drugs can cause sexual dysfunction in both women and men. Determining the potential benefits of vardenafil, tadalafil, or sildenafil is much more complex than for drugs that are used to treat cancer, heart disease, or high blood pressure, for example, where one of the potential benefits may be increased survival or avoidance of a heart attack or stroke. It is unlikely that untreated ED contributes to decreased survival, even though it may contribute to emotional distress and strained relationships.
Adrenal Steroids
There are three types of adrenal steroids: mineralocorticoids, which maintain sodium and potassium balance in the body, glucocorticoids, and male sex steroids (although most male sex hormones are produced in the testicles). Our Web site only considers glucocorticoids.
Urinary System
It is important to distinguish between urge incontinence, overflow incontinence, stress incontinence, and a fourth form of incontinence called functional incontinence (incontinence due to ambulatory difficulties or inadequate access to a toilet), as each has different treatments.
Sleeping Pills and Tranquilizers
Older adults have a much more difficult time eliminating benzodiazepines and similar drugs from their bloodstreams and these drugs can thus accumulate in their bodies. Also, older adults are more sensitive to the effects of many of these drugs than are younger adults. For older adults the risk of serious adverse drug effects is significantly increased. Serious adverse effects may include: unsteady gait, dizziness, falling (causing an increased risk of hip fractures), increased risk of an auto accident, drug-induced or drug-worsened impairment of thinking, memory loss, and addiction.
Antipsychotic Drugs: Dangerously Overused
Antipsychotic drugs, also called neuroleptic drugs or major tranquilizers, are properly and successfully used to treat serious psychotic mental disorders, the most common of which is schizophrenia. In younger adults, an alarming number of those with schizophrenia who could and often have previously benefited from antipsychotic drugs are not receiving them. They are seen, among other places, on the streets and in homeless shelters. In older adults, the problem is not underuse but, rather, gross overuse by people who are not psychotic.
Depression: When are Drugs Called For And Which Ones Should You Use?
Ironically, one of the kinds of depression that should not be treated with drugs is depression caused by other kinds of drugs. If someone is depressed and the depression started after beginning a new drug, it may well be drug-caused. Commonly used drugs known to cause depression include the following:
Application of Eye Drops and Ointments; Glaucoma
The normal eye can hold about 10 microliters (10 millionths of a quart) of liquid. A single drop formed by an eye dropper, however, ranges from 25 to 50 microliters. What happens to the excess 15 to 40 microliters when you apply eye drops? Two things occur:
Alzheimer's Disease
The strategy to sell Alzheimer’s disease drugs is based on hope, fear, and guilt: hope that one of these drugs might work, fear that if one of these drugs is not started quickly, all will be lost; and guilt if family members have not made the decision to fight the disease with expensive, sometimes dangerous, drugs. Recent reviews by the U.S. Preventive Services Task Force and the American Academy of Neurology are appropriately skeptical of the use of these drugs.
Salicylates and Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
The salicylates are used to relieve pain and to reduce fever and inflammation. Aspirin, a nonsteroidal anti-inflammatory drug (NSAID), is the most well-known and frequently used salicylate. Other salicylates discussed on this web site are salsalate and choline and magnesium salicylates.
Opioids
Most of the time when someone is able to swallow, they should first try a non-opioid drug such as aspirin taken by mouth. If aspirin alone is not effective, it can be combined with an opioid, such as codeine. These two drugs work in different ways, and when they are used together, they generally relieve pain that would otherwise require a higher dose of an opioid, while causing fewer adverse effects.
Arthritis and Inflammation
At least 31.6 million Americans suffer from some form of arthritis. The three most common types are rheumatoid arthritis, osteoarthritis, and gout. Each has a different cause, treatment, and probable outcome.
Ulcers and Gastroesophageal Reflux Disease (GERD)
There are nondrug treatments, with no safety concerns, and less expensive drugs that may be effective for GERD; these should be tried before you use any drugs for heartburn. First, try to avoid foods that trigger your condition (e.g., fatty foods, onions, caffeine, peppermint, and chocolate), and avoid alcohol, smoking, and tight clothing. Second, avoid food, and particularly alcohol, within two or three hours of bedtime. Third, elevate the head of the bed about six inches or sleep with extra pillows.
Irritable Bowel Syndrome
The FDA has approved drugs for both diarrhea-predominant and constipation-predominant IBS. The former, alosetron (LOTRONEX) , had to be removed from the market after it caused serious constipation and a condition of decreased blood flow to the intestine called ischemic colitis. The latter, tegaserod (ZELNORM), has also been associated with ischemic colitis and severe, disabling diarrhea, and it is barely effective.
Constipation
When do you really need to take a laxative? You should not take a laxative to “clean out your system” or to make your body act more normally. It is untrue that everyone must have a bowel movement daily. Perfectly healthy people may have from three bowel movements per week to three bowel movements per day.
Diarrhea
How to Treat Acute Simple Diarrhea Do not eat or drink milk and dairy products, fresh fruits and vegetables, coffee, spicy foods, or other food you do not tolerate well. Do not consume drinks with a high sugar content, such as grape juice, apple juice, and soft drinks, including cola, ginger ale, and sports drinks. Do not eat highly sweetened foods such as candy, ice cream, or Jell-O because they have too much sugar, which can make the diarrhea worse.Drink plenty of ORS (see formula in box).
Gas
One of the miracles of modern Madison Avenue marketing is that the public is still spending money for simethicone, alone or in combination with other drugs, for gas or infant colic. Despite the millions spent on advertising to convince us otherwise, the feeling of bloating and pain after eating is not caused by gas. There is no relation between these symptoms and the amount of gas in the intestinal tract. The use of antigas products to relieve this discomfort is inappropriate, as there is no medical need to expel gas from the body.
Vitamins and Minerals
One promotional strategy of supplement suppliers is to make people worry about whether they are getting enough nutrients. But do most people really need to take vitamins and minerals to supplement their diets? Or are they a waste of money? Are there better alternatives to taking supplements to ensure adequate nutrition? This section will attempt to answer these questions and help you sort through the fact and fiction surrounding nutritional supplements.
Cough and Cold
Many prescription or over-the-counter drug combinations of two or more ingredients should not be used because they are irrational combinations of single ingredients, some of which are safe and effective and sensible to use alone if treating the symptom for which they are intended. The combinations, however, present extra risks for extra ingredients that will usually not add any benefit (possibly a risk) to the first ingredient and will invariably cost much more than the single ingredient alone.
Asthma, Chronic Bronchitis and Emphysema
Do not try to diagnose or treat yourself. Asthma, chronic bronchitis, and emphysema must be diagnosed and treated by a doctor or other health professional. Two other common conditions that cause breathing difficulties, congestive heart failure and pneumonia, have similar symptoms, and many of the drugs used to treat asthma or COPD may worsen these conditions. Therefore, it is extremely important that you have your condition properly diagnosed before starting any medication.
Allergy and Hayfever
If you suffer from an itchy and runny nose, watery eyes, sneezing, and a tickle in the back of your throat, then you probably have an allergy. An allergy means a hypersensitivity to a particular substance called an allergen. Hypersensitivity means that the body’s immune system, which defends against infection, disease, and foreign bodies, reacts inappropriately to the allergen. Examples of common allergens are pollen, mold, ragweed, dust, feathers, cat hair, makeup, walnuts, aspirin, shellfish, poison ivy, and chocolate.
Antibiotics
Antibiotics (drugs used to treat bacterial infections) are overwhelmingly misprescribed in the United States. Despite congressional hearings and numerous academic studies on this issue, it has become the general consensus that 40 to 60% of all antibiotics in this country are misprescribed. New studies continue to confirm the fact that a large proportion of antibiotic prescribing for both children and adults continues to be inappropriate.
Penicillins and Cephalosporins
Penicillins are a group of antibiotics used to kill bacteria or prevent infections. They are probably the least toxic of all the antibiotics. The penicillins are some of the most commonly prescribed antibiotics and are often the drugs of choice for people who are not allergic to them. Cephalosporins are relatives of the penicillins and have a similar, if slightly expanded, range of action. They have a good safety record but certain problems can occur with their use. Diarrhea is the most common adverse effect, and it may become so bad that treatment must be stopped.
Fluoroquinolones
One of the biggest-selling and most overprescribed classes of drugs in the United States is the family called fluoroquinolones. One clue that a drug your doctor wants to give you is in this class is the fact that the generic names of all such drugs approved in the United States include the sequence floxacin. These drugs have been alternatives for individuals allergic to, or with infections resistant to, other antibiotics. Some fluoroquinolones are commonly misprescribed for colds, sore throats, bladder infections, or community-acquired (as opposed to hospital-acquired) pneumonia.
Tetracyclines
Tetracyclines are rarely the antibiotics of choice to treat bacterial infections that are common in older adults. In general, tetracyclines are used to treat such infections as urethritis (inflammation of the urinary tract), prostate infections, pelvic inflammatory disease, acne, Rocky Mountain spotted fever, recurrent bronchitis in people with chronic lung disease, walking pneumonia, and other miscellaneous infections.
High Blood Pressure
A study of nutritional therapy showed that over one-third of people who previously needed drug treatment for high blood pressure were able to adequately control their blood pressure with nutritional therapy alone.Several factors should be taken into account when considering whether your high blood pressure should be treated. One is the benefits of the treatment for your blood pressure, which vary significantly depending on how high it is, your age, and whether you have other risk factors such as high cholesterol or are a smoker or a diabetic, and whether you have had a heart attack, heart failure, a stroke, or have kidney damage. The other consideration is the risks or the adverse effects of the treatment, which will vary depending on what is being considered.
Elevated Cholesterol Levels
The evidence for treatment, especially with cholesterol-lowering drugs, is much weaker for people who have not yet had the cardiovascular disease described above, known as primary prevention. This is especially so for those people who do not have more than one of the following risk factors: hypertension, diabetes, smoking, obesity, or a close family history of premature heart attacks or strokes.
Potassium Supplementation
Very few people actually need to take a potassium supplement or a potassium-sparing diuretic (amiloride, spironolactone, triamterene). If, however, you take digoxin, have severe liver disease, or take large doses of diuretics (water pills) for heart disease, eating a potassium-rich diet may not be sufficient to replace the potassium that you are losing. If you fall into one of these categories, it is very important for your doctor to precisely monitor and regulate the amount of potassium in your bloodstream.
Dietary and Herbal Supplements
In the other chapters of this book, we have had access to published articles describing randomized, controlled trials in medical journals, medical textbooks, the FDA-approved label, and, importantly, the detailed review of the drug (based on a review of the raw data from the sponsor’s clinical trials) conducted by the FDA medical officer, at least for more recent drugs. This evidence base is far from complete for any dietary supplement. By definition, no supplement has passed an FDA safety and efficacy review (otherwise it would be a drug).
Protecting Yourself and Your Family from Preventable Drug-induced Injury
Doctors and pharmacists often blame the adverse effects of prescription drugs on patients, accusing them of improperly taking their medications. The standard solution offered by some health professionals is to get patients to better “comply” with doctors’instructions by using what are called compliance programs or strategies. (Another word for compliance is, of course, obedience.) Occasionally, the blame is also put on doctors for misprescribing and overprescribing, on pharmacists for failing to detect serious drug interactions, and only rarely on the drug industry for overselling drugs to doctors and now directly to patients through direct-to-consumer advertising.
Saving Money When Buying Prescription Drugs
For many people in the United States, the price of prescription drugs is unaffordable. Many drugs cost $500, $1,000, $2,000, or more per drug and many people are taking more than one of them. Although the majority of these drugs have not yet come off patent and generic equivalents are therefore not available, the lack of the kind of price controls that exist in all other developed countries (and in the Department of Defense and the Veteran’s Administration in the United States) presents an insufferable financial burden for too many people. This section of our web site discusses five ways to save on prescription drugs.
Myths and Facts About Generic Drugs
Unless you want to waste a large amount of money—often hundreds of dollars a year—by using brand-name instead of generic drugs, you should ask for the generic version, especially if you are starting on a drug for the first time. One of the few bits of comparative information about prescription drugs readily accessible to consumers is the retail price of brand-name versus generic drugs. You can get this information easily by asking your pharmacist.
Ten Rules for Safer Drug Use
Ten straightforward ways to reduce you and your family's chances of being injured by drugs. The rules include communicating more effectively with your health care providers, using the lowest effective dose of your medication, adjusting the dose for your age and deciding whether you are experiencing an adverse effect from your drugs.
For Prescriptions, Eye Doctors Recommend Using One Drop per Eye, Not Two
Ophthalmologists consulting for the Medical Letter generally agree that all eye drops should only be used in a dose of one drop because there is a smaller chance of an overdose with one drop. Also, using one drop instead of two makes more efficient use of the medicine.
Used as a Glaucoma Treatment, Beta-Blocker Eye Drops May Cause Serious Adverse Reactions in Some
You should not use beta blocker eye drops to treat glaucoma if you have pre-existing breathing or certain heart conditions.
Combination Treatments for Helicobacter Pylori Infection
The bacterium Helicobacter pylori (H. pylori) has been implicated in causing ulcer disease. The combination treatments described have high success rates and low recurrence rates, but the treatment is arduous.
Public Citizen Sues FDA for Failing to Act on Petition to Remove Darvon from the Market
Public Citizen sues the Food and Drug Administration after the agency failed to act on the organization's two-year-old petition to remove all drugs containing propoxyphene, including Darvon and Darvocet.
Dangers of Mixing Alcohol with Certain Medications or Diseases
The article discusses 273 drugs that can have harmful interactions with alcohol. Also reviewed are several ways in which these harmful interactions can occur: 1/ Medications Can Increase Alcohol Blood Levels 2/ Additive effects of medications and alcohol. One of the best- known drug-alcohol interactions is when alcohol, a depressant, is taken with other sedative medications, and excessive sedation or depression of respiration can occur 3/Alcohol can increase the blood levels of some medications leading to toxicity of these drugs. 4/ Alcohol also can reduce blood levels of some medications causing them to be less effective. Although some of the interactions between alcohol and medications mainly occur in people who drink heavily (three or more drinks on one occasion), many of these interactions may occur with much lower amounts of alcohol use, such as one to two drinks on an occasion. We strongly urge you to tell your physicians and other health care providers how much alcohol you are drinking so they can effectively assess the risks and advise you about the safe use of alcohol and medications.
29 Medications That May Cause Adverse Interactions with Thyroid Drugs
Thyroid medications are among the most widely-prescribed drugs in the U.S. In this article, we review 29 different medications that can have harmful interactions with thyroid medicines such as levothyroxine (Synthroid). There are four major kinds of interaction problems that can occur: • Certain medications can decrease the absorption of levothyroxine resulting in lower levels in the blood. • Other medications can increase the rate at which the body gets rid of levothyroxine, also resulting in lower thyroid levels in the blood. • Other medications can cause changes of levothyroxine binding in blood, decreasing the body's ability to use levothyroxine. • Levothyroxine can affect the safety or effectiveness of other medications by raising or lowering the levels of these other drugs in the blood, causing them to be either infective (lower levels) or dangerous (higher levels).
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DRUG AND DIETARY SUPPLEMENT PROFILES

A comprehensive review of the safety and effectiveness of this drug. If the drug is not a Do Not Use product, information on adverse effects, drug interactions and how to use the medication are included.

orlistat (ALLI, XENICAL)
  • We list this drug as a Do Not Use drug because it has not been shown to cause long-term health benefits.
sibutramine (MERIDIA)
  • We list this drug as a Do Not Use drug because it causes very limited weight loss and also causes high blood pressure and increased heart rate.
thyroid tablets USP (ARMOUR THYROID, NATURE-THROID, NP THYROID, WESTHROID, WP THYROID)
  • We list this drug as a Do Not Use drug because it is not adequately guaranteed to provide appropriate blood levels of thyroid hormone and reliable alternatives are available.
desogestrel and ethinyl estradiol (APRI, CAZIANT, CESIA, CYCLESSA, DESOGEN, MIRCETTE, ORTHO-CEPT, RECLIPSEN, SOLIA, VELIVET)
  • We list these drugs as Do Not Use drugs because they cause blood clots and are no more effective than other oral contraceptives in preventing pregnancy.
drospirenone and ethinyl estradiol (GIANVI, MELAMISA, NIKKI, YASMIN, YAZ, ZARAH)
  • We list this drug as a Do Not Use drug because it can cause increased blood levels of potassium and is no more effective than other oral contraceptives in preventing pregnancy.
dexmethylphenidate (FOCALIN, FOCALIN XR)
  • We list this drug as a Do Not Use drug because it has no advantage over similar drugs with longer safety records.
pemoline (CYLERT)
  • We list this drug as a Do Not Use drug because the evidence for its effectiveness is limited and it causes liver damage.
esterified estrogens with methyltestosterone (ESTRATEST, ESTRATEST HS)
  • We list these drugs as Do Not Use drugs because the male hormone portion of this combination drug does not add to its effectiveness.
acetohexamide (DYMELOR); chlorpropamide (DIABINESE, GLUCAMIDE)
  • We list these drugs as Do Not Use drugs because they are more likely than similar drugs for diabetes to cause low blood sugar.
pioglitazone (ACTOS); rosiglitazone (AVANDIA)
  • We list these drugs as Do Not Use drugs because they may be less effective than other drugs for diabetes and cause liver damage, weight gain, anemia and heart failure.
nateglinide (STARLIX); repaglinide (PRANDIN)
  • We list these related drugs as Do Not Use drugs because one of them is less effective than other drugs available for diabetes.
isometheptene, dichloralphenazone and acetaminophen (MIDRIN)
  • We list this drug as a Do Not Use drug because each of the active ingredients included in this drug do not contribute to the drug's effectiveness, as required by law.
carisoprodol (SOMA); carisoprodol with aspirin (SOMA COMPOUND); carisoprodol, aspirin and codeine (SOMA COMPOUND WITH CODEINE)
  • We list these drugs as Do Not Use drugs because it is no more effective than aspirin and related drugs, is sedating and breaks down into a chemical with a potential for abuse.
chlorzoxazone (PARAFON FORTE DSC)
  • We list this drug as a Do Not Use drug because it is no more effective than aspirin and related drugs, is sedating and can cause liver damage.
cyclobenzaprine (FLEXERIL)
  • We list this drug as a Do Not Use drug because it is no more effective than aspirin and related drugs and is sedating.
methocarbamol (ROBAXIN)
  • We list this drug as a Do Not Use drug because it is no more effective than aspirin and related drugs and is sedating.
orphenadrine (INVAGESIC, NORFLEX); orphenadrine and aspirin and caffeine (NORGESIC, NORGESIC FORTE, ORPHENGESIC, ORPHENGESIC FORTE)
  • We list these drugs as Do Not Use drugs because the main ingredient is no more effective than aspirin and related drugs and has the same adverse effects as antihistamines.
amitriptyline
  • We list this drug as a Do Not Use drug because it has more adverse effects than related drugs.
amitriptyline and chlordiazepoxide (LIMBITROL)
  • We list this drug as a Do Not Use drug because it is an irrational combination of two other Do Not Use drugs.
amitriptyline and perphenazine (TRIAVIL)
  • We list this drug as a Do Not Use drug because it is an irrational combination of one drug with another Do Not Use drug.
calcitonin [calcitonin-salmon] (FORTICAL, MIACALCIN)
  • We list this drug as a Do Not Use drug because, unlike other drugs for osteoporosis, there is no clear evidence that it can reduce the rate of new fractures.
teriparatide (FORTEO)
  • We list this drug as a Do Not Use drug because it has not been shown to reduce fractures in men and caused bone cancer in animal studies.
thioridazine (MELLARIL)
  • We list this drug as a Do Not Use drug because it is more likely to cause irregular heartbeat than related drugs.
nefazodone (SERZONE)
  • We list this drug as a Do Not Use drug because it causes liver failure.
ziprasidone (GEODON, ZELDOX)
  • We list this drug as a Do Not Use drug because it is no more effective than older drugs for schizophrenia and causes irregular heartbeat.
zaleplon (SONATA)
  • We list this drug as a Do Not Use drug because it is less effective than related drugs and can cause addiction.
mesoridazine (SERENTIL (DISCONTINUED))
  • We list this drug as a Do Not Use drug because, unlike some other drugs available for schizophrenia, it causes an irregular heartbeat.
meprobamate (EQUANIL, MILTOWN)
  • Do Not Use: This drug is sedating and addictive and can cause hip fractures. There are safer drugs available.
sulfacetamide and prednisolone (BLEPHAMIDE, VASOCIDIN)
  • We list this drug as a Do Not Use drug because it is an irrational combination of ingredients and there is no persuasive evidence that it is effective.
neomycin and dexamethasone (NEODECADRON); neomycin p, polymyxin b, and dexamethasone (MAXITROL)
  • We list these drugs as Do Not Use drugs because they are an irrational combination of ingredients and there is no persuasive evidence that they are effective.
phenazopyridine (PYRIDIUM)
  • We list this drug as a Do Not Use drug because it has questionable effectiveness and causes anemia and liver damage, as well as cancer in animals.
indomethacin (INDOCIN, TIVORBEX)
  • We list this drug as a Do Not Use drug because it is no more effective than related drugs and causes a higher rate of ulcers.
ketorolac (SPRIX)
  • We list this drug as a Do Not Use drug because it is no more effective than related drugs and causes a higher rate of ulcers.
piroxicam (FELDENE)
  • We list this drug as a Do Not Use drug because it is no more effective than related drugs and causes a higher rate of ulcers and skin reactions.
celecoxib (CELEBREX, ELYXYB); meloxicam (MOBIC); rofecoxib (VIOXX); valdecoxib (BEXTRA)
  • We list these drugs as Do Not Use drugs because they are no more effective than related drugs, most have not been shown to have a lower rate of ulcers than related drugs and some have been shown to cause heart disease.
buffered aspirin (ASCRIPTIN, BUFFERIN); diflunisal (DOLOBID); salsalate (DISALCID)
  • We list these drugs as Do Not Use drugs because they have no advantage over ordinary generic aspirin in safety or effectiveness.
donepezil (ARICEPT, ARICEPT 23); tacrine (COGNEX)
  • We list these drugs as Do Not Use drugs primarily because they are minimally effective.
galantamine (RAZADYNE, RAZADYNE ER); rivastigmine (EXELON)
  • We list these drugs as Do Not Use drugs primarily because they are minimally effective.
memantine (NAMENDA)
  • We list this drug as a Do Not Use drug primarily because there is no persuasive evidence that it is effective.
ergoloid mesylates ()
  • We list these drugs as Do Not Use drugs because there is no evidence that they are effective.
butorphanol
  • We list this drug as a Do Not Use drug because it is no more effective than related drugs, is more expensive and is addictive.
pentazocine and naloxone (TALWIN-NX)
  • We list this drug as a Do Not Use drug because it causes more confusion and hallucinations than related drugs.
tramadol (CONZIP, QDOLO, ULTRAM); tramadol and acetaminophen (ULTRACET)
  • We list these drugs as Do Not Use drugs because they are no more effective than similar drugs, are addictive and cause seizures.
butalbital, acetaminophen and caffeine (ESGIC PLUS, FIORICET); butalbital, caffeine and aspirin (FIORINAL); butalbital, caffeine, aspirin and codeine (FIORINAL WITH CODEINE)
  • We list these drugs as Do Not Use drugs because they are irrational combinations that include drugs that are unsafe or ineffective.
benztropine (COGENTIN); trihexyphenidyl
  • We list this drug as a Do Not Use drug because it causes memory impairment, confusion, hallucinations, and retention of urine.
tolcapone (TASMAR)
  • We list this drug as a Do Not Use drug because it causes liver failure.
leflunomide (ARAVA)
  • We list this drug as a Do Not Use drug because it may be less effective than other drugs and causes liver damage and high blood pressure.
niacin [extended release] [vitamin B3] (NICOBID, SLO-NIACIN)
  • We list this drug as a Do Not Use drug because it causes liver damage, unlike other forms of this drug.
vitamin E [alpha tocopherol]
  • We list this drug as a Do Not Use drug because Vitamin E deficiency is rare and Vitamin E has not been proved to prevent heart attacks or for any other medical purpose.
indapamide (LOZOL)
  • We list this drug as a Do Not Use drug because it is no more effective than similar drugs and causes low blood sodium levels.
amiloride and hydrochlorothiazide (MODURETIC)
  • We list this drug as a Do Not Use drug because it is an irrational combination of ingredients and can lead to high blood potassium levels.
spironolactone and hydrochlorothiazide (ALDACTAZIDE)
  • We list this drug as a Do Not Use drug because it is an irrational combination of ingredients and can lead to high blood potassium levels, kidney failure, confusion and paralysis.
triamterene (DYRENIUM)
  • We list this drug as a Do Not Use drug because it can lead to high blood potassium levels, kidney stones, kidney failure, and bone marrow toxicity.
nifedipine [short acting] (ADALAT, PROCARDIA)
  • We list this drug as a Do Not Use drug because it can cause low blood pressure, heart attack and stroke.
amlodipine and benazepril (LOTREL); felodipine and enalapril (LEXXEL); verapamil and trandolapril (TARKA)
  • We list this drug as a Do Not Use drug because it does not contain any of the first-line treatments for high blood pressure.
doxazosin [heart] (CARDURA [HEART]); prazosin (MINIPRESS); terazosin [heart] (HYTRIN [HEART])
  • We list these drugs as Do Not Use drugs because they are less effective than first-line treatments for high blood pressure.
clonidine (CATAPRES, KAPVAY, NEXICLON XR); clonidine and chlorthalidone (CLORPRES, COMBIPRES); clonidine transdermal therapeutic system (CATAPRES-TTS)
  • We list these drugs as Do Not Use drugs because clonidine causes depression and missing one or two doses can lead to sweating, tremors, flushing, and severe high blood pressure.
gemfibrozil (LOPID)
  • We list this drug as a Do Not Use drug because, unlike for other drugs for high cholesterol, there is no evidence that it decreases the risk of heart disease. It also causes cancer in animals.
fenofibrate (ANTARA, FENOGLIDE, LIPOFEN, TRICOR, TRIGLIDE, TRILIPIX)
  • We list this drug as a Do Not Use drug because studies of other drugs in its class show them to lead to pancreatitis, gallstones, cancer and an increased risk of death.
azelastine (ASTELIN, ASTEPRO, OPTIVAR)
  • We list this drug as a Do Not Use drug because it is no safer or more effective than oral antihistamines, but is more expensive.
rosuvastatin (CRESTOR, EZALLOR, EZALLOR SPRINKLE)
  • We list this drug as a Do Not Use drug because it causes kidney, muscle and liver damage.
desloratadine (CLARINEX)
  • We list this drug as a Do Not Use drug because it is merely a breakdown product, and no more safe and effective, than another drug that was losing patent protection.
pseudoephedrine (ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, SUDAFED, SUDAFED 12 HOUR, SUDOGEST)
  • We list this drug as a Do Not Use drug because it raises heart rate and blood pressure and causes heart attacks and strokes.
dextromethorphan (BROMFED DM, DELSYM)
  • We list this drug as Do Not Use a drug because it is not effective.
cilostazol (PLETAL)
  • We list this drug as a Do Not Use drug because it has limited effectiveness and may lead to an increased risk of death.
pentoxifylline ()
  • We list this drug as a Do Not Use drug because it has limited effectiveness and may cause bone marrow toxicity.
ticlopidine (TICLID)
  • We list this drug as a Do Not Use drug because it is only somewhat more effective than aspirin, but causes bone marrow toxicity and high blood cholesterol levels.
guaifenesin (MUCINEX, ROBITUSSIN)
  • We list this drug as a Do Not Use drug because there is not adequate evidence for its effectiveness.
fexofenadine and pseudoephedrine (ALLEGRA D); loratadine and pseudoephedrine (CLARITIN D, CLARITIN D 24); promethazine and phenylephrine (PROMETHAZINE VC); triprolidine and pseudoephedrine (ACTIFED)
  • We list this drug as a Do Not Use drug because it is an irrational combination of ingredients and the individual ingredients either have safer alternatives or are ineffective.
hydrocodone and chlorpheniramine (TUSSICAPS); promethazine and codeine (); promethazine and dextromethorphan ()
  • We list these drugs as Do Not Use drugs because they contain an irrational combination of ingredients.
pseudoephedrine, triprolidine, and codeine (TRIACIN-C)
  • We list this drug as a Do Not Use drug because it is an irrational combination of ingredients and for one ingredient a safer alternative is available.
guaifenesin and dextromethorphan (MUCINEX DM, ROBITUSSIN COUGH+CHEST CONGESTION DM, ROBITUSSIN-DM)
  • We list this drug as a Do Not Use drug because it is an irrational combination of two Do Not Use drugs.
guaifenesin and pseudoephedrine (GUIFENEX PSE, MUCINEX D, ROBITUSSIN PE SYRUP)
  • We list this drug as a Do Not Use drug because it is an irrational combination of ingredients and one of the ingredients is ineffective.
hydrocodone and homatropine
  • We list this drug as a Do Not Use drug because it is an irrational combination of ingredients and one ingredient causes memory impairment, confusion, hallucinations, and retention of urine, without clear evidence that it is effective.
fluticasone propionate and salmeterol inhalation powders (ADVAIR DISKUS, ADVAIR HFA)
  • We list this drug as a Do Not Use drug because it has been associated with an increased death rate and safer alternatives are available.
salmeterol (SEREVENT)
  • We list this drug as a Do Not Use drug because it has been associated with an increased death rate and safer alternatives are available.
isoetharine (BETA-2, BRONKOMETER, BRONKOSOL)
  • We list this drug as a Do Not Use drug because it is more likely to increase blood pressure and heart rate than other drugs for this condition.
magnesium hydroxide, aluminum hydroxide and simethicone (MYLANTA, MYLANTA-II)
  • We list this drug as a Do Not Use drug because it contains an ineffective ingredient.
oxtriphylline (CHOLEDYL SA)
  • We list this drug as a Do Not Use drug because it is no more effective but is more expensive than similar drugs.
montelukast (SINGULAIR); zafirlukast (ACCOLATE)
  • We list these drugs as Do Not Use drugs because they are less effective than other drugs and can cause blood vessel inflammation, liver disease, lupus and recurrences of ulcerative colitis.
erythromycin estolate
  • We list this drug as a Do Not Use drug because, unlike other forms of this drug, this form causes liver damage.
telithromycin (KETEK)
  • We list this drug as a Do Not Use drug because it is no more effective than other antibiotics and causes irregular heartbeat.
moxifloxacin (AVELOX)
  • We list theses drugs as Do Not Use drugs because they are no more effective than similar drugs and cause irregular heartbeat.
alosetron (LOTRONEX)
  • We list this drug as a Do Not Use drug because irritable bowel syndrome is not life-threatening, the drug is minimally effective and it causes lack of blood flow to the intestines and severe constipation.
tegaserod (ZELMAC, ZELNORM)
  • We list this drug as a Do Not Use drug because irritable bowel syndrome is not life-threatening, the drug is minimally effective, and it causes diarrhea, ovarian cysts and lack of blood flow to the intestines.
trovafloxacin (TROVAN)
  • We list this drug as a Do Not Use drug because it causes liver failure.
gemifloxacin (FACTIVE)
  • We list this drug as a Do Not Use drug because it causes severe rashes and may cause irregular heartbeat and liver damage.
trimethobenzamide (TIGAN)
  • We list this drug as a Do Not Use drug because there is no convincing proof that it is effective.
atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate and benzoic acid (URISED)
  • We list this drug as a Do Not Use drug because it is an irrational combination of six ingredients.
neomycin, polymyxin b, and bacitracin (MYCITRACIN, NEOSPORIN MAXIMUM STRENGTH OINTMENT); neomycin, polymyxin b, and hydrocortisone (CORTISPORIN)
  • We list this drug as a Do Not Use drug because there is no convincing evidence that it is effective.
betamethasone and clotrimazole (LOTRISONE CREAM)
  • We list this drug as a Do Not Use drug because it is an irrational combination of ingredients.
terbinafine (LAMISIL); itraconazole (ONMEL, SPORANOX, TOLSURA)
  • We list these drugs as Do Not Use drugs because toenail fungus is a cosmetic condition and these drugs have been associated with liver and/or heart failure.
nystatin and triamcinolone (MYCO-BIOTIC II, MYCOLOG II)
  • We list this drug as a Do Not Use drug because it is an irrational combination of ingredients.
lindane (KWELL)
  • We list this drug as a Do Not Use drug because it is less effective than other products for this condition and causes central nervous system toxicity, including seizures, particularly in small children.
zanamivir (RELENZA)
  • We list this drug as Do Not Use because it is only minimally effective and can cause asthma.
black cohosh (AWARENESS FEMALE BALANCE, ESTROVEN, REMIFEMIN)
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective.
coenzyme q10 [co q 10, q10, vitamin q10, ubiquinone, ubidecarenone] (ANTI-AGING DAILY PREMIUM PAK, Q-GEL, VITAMIST INTRA-ORAL SPRAY)
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective.
echinacea [purple coneflower, red sunflower, thimbleweed, rudbeckia] (HALLS DEFENSE MULTI-BLEND SUPPLEMENT DROPS)
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective.
ephedra [ma huang, chinese ephedra, epitonin]
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective and it causes heart attacks, strokes and seizures.
garlic (KWAI, PHYTO-VITE)
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective.
glucosamine and chondroitin (DONA, FLEXIJOINT, FLEXIPURE, MAJESTIC EARTH, MOVE FREE, OSTEO BI-FLEX, TRIPLE FLEX)
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective.
green tea
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective.
milk thistle (MILK THISTLE HEALTH LIVER, RELIVE, THISILYN)
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective.
morinda citrifolia [noni, nono, nonu, ba ji tian, nhau] (PREMIUM HAWAIIAN NONI JUICE, TAHITIAN NONI LIQUID)
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective.
saw palmetto [serenoa repens; serenoa serrulata; sabal serrulata] (ONE-A-DAY PROSTATE HEALTH, PERMIXON, POWER LASTING)
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective.
St. John's wort [hypericum, goatweed, the lord god's wonder plant, witch's herb] (SUN BEAUTY)
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective and it interacts with many other drugs.
bisacodyl (DULCOLAX); docusate (COLACE, SURFAK); docusate and casanthranol (DIALOSE PLUS, PERI-COLACE)
  • We list these drugs as Do Not Use drugs because they can lead to dependence and safer alternatives are available.
diphenoxylate and atropine (LOMOTIL, LONOX)
  • We list this drug as a Do Not Use drug because it can cause breathing difficulty.
atropine; atropine, hyoscyamine, scopolamine, and phenobarbital (DONNATAL); dicyclomine (BENTYL); hyoscyamine (LEVBID, LEVSIN)
  • We list these drugs as Do Not Use drugs because all contain an ingredient that can cause sedation and one is an irrational combination of ingredients.
chlordiazepoxide and clidinium (LIBRAX)
  • We list this drug as a Do Not Use drug because it is an irrational combination of dangerous drugs and there is no evidence that it is effective.
simethicone (GENASYME, INFACOL, MYLICON, PHAZYME)
  • We list this drug as a Do Not Use drug because there is no evidence that it is effective.
baricitinib (OLUMIANT)
  • We list this drug as Do Not Use because it has unique risks of serious harm — in particular, an increased risk of life-threatening blood clots — without offering any unique benefits over other disease-modifying antirheumatic drugs.
mirabegron (MYRBETRIQ)
  • We list this drug as Do Not Use because the drug’s significant risks far outweigh its minimal benefits for treatment of overactive bladder.
desmopressin (NOCDURNA)
  • We list this drug as Do Not Use because its significant risks far outweigh its minimal benefits for treating nocturia (nighttime urination).
paroxetine mesylate (BRISDELLE)
  • We list this drug as Do Not Use because it has questionable benefits for women with hot flashes but carries well-established risks, including depression.
olmesartan (BENICAR); olmesartan and hydrochlorothiazide (BENICAR HCT); olmesartan with amlodipine (AZOR); olmesartan with hydrochlorothiazide plus amlodipine (TRIBENZOR)
  • Public Citizen’s Health Research Group has designated all olmesartan-containing medications as Do Not Use because olmesartan has been shown to cause severe, life-threatening adverse gastrointestinal effects.
milnacipran (SAVELLA)
  • We list this drug as Do Not Use because it offers minimal benefit and has serious risks.

WORST PILLS, BEST PILLS NEWSLETTER ARTICLES
Zuranolone, an Oral Medication for Postpartum Depression
March 2024
Mental health conditions that result in suicide or death from overdose or poisoning are the leading causes of preventable postpartum deaths. In 2023, the FDA approved zuranolone (ZURZUVAE), an oral medication for postpartum depression. Learn why Public Citizen’s Health Research Group has classified zuranolone as Do Not Use for Seven Years.
Remembering Sidney M. Wolfe, M.D., 1937-2024
March 2024
Dr. Sidney M. Wolfe, the cofounder of the Health Research Group and an iconic and inspirational champion of public health, died on January 1, 2024, at age 86. In his monthly column, Dr. Robert Steinbrook, the current Health Research Group director, reflects on Sid’s legacy and his vision, passion, and integrity.
Public Citizen Urges FDA To Strengthen Warning on Labeling of BOTOX and Related Drugs
March 2024
In December 2023, Public Citizen’s Health Research Group petitioned the Food and Drug Administration to promptly strengthen the safety warning on the labeling of BOTOX and related drugs. Learn about the petition and our concerns about the risk of iatrogenic botulism, a muscle-paralyzing disease, and related symptoms.
Important Drug Interactions for the Type 2 Diabetes Drug Metformin
March 2024
Metformin is a recommended first-line treatment for patients with type 2 diabetes who are not able to control their blood sugar through diet and exercise alone. Metformin, however, has important drug interactions and can cause a serious condition called lactic acidosis, a buildup of lactic acid in the blood. Learn about metformin’s drug interactions.
FDA Approval of a CRISPR/Cas9 Gene Therapy To Treat Sickle Cell Disease
March 2024
In 2023, the Food and Drug Administration (FDA) approved two cell-based gene therapies for the treatment of sickle cell disease. One of these treatments is the first FDA-approved treatment using CRISPR/Cas9 gene-editing technology. Although cell-based gene therapies for sickle cell disease are promising, they are new, and their long-term effectiveness and safety are not known.
Long-Term Risks with the Use of Proton Pump Inhibitors
February 2024
Proton pump inhibitors (PPIs) reduce the amount of stomach acid. They are available by prescription and over the counter, and their use has increased in recent years. Although PPIs are generally safe for short-term use, they have serious long-term risks.
New FDA Rules for Risk Information in Direct-to-Consumer Advertisements for Prescription Drugs
February 2024
In November 2023, the Food and Drug Administration finalized its rules for the disclosure of risk information in television and radio direct-to-consumer advertisements of prescription drugs. Learn about the standards for disclosing a product’s major adverse effects and contraindications.
Recommendation Reaffirmed for Folic Acid Supplementation to Prevent Birth Defects
February 2024
In 2023, the U.S. Preventive Services Task Force reaffirmed its recommendation that all persons who are planning to or could become pregnant take a daily supplement containing 400 to 800 micrograms of folic acid starting at least one month before conception and continuing through the end of the first trimester of pregnancy. Learn about the evidence supporting this recommendation.
New Analysis: Daily Low-Dose Aspirin Not Beneficial for Preventing a First Stroke in Healthy Older Adults
February 2024
Preventing strokes is a public health priority. A recent study found, however, that the use of daily low-dose aspirin was not beneficial in preventing a first stroke in healthy older adults. Among every 1,000 subjects taking low-dose aspirin over five years, there were 2.5 fewer strokes at the expense of 3.5 cases of bleeding in the brain.
What Is the FDA’s Role in the Development of New Antibiotics?: The Case of Recarbrio
February 2024
An egregious example of the low standards for the approval of new antibiotics is the Food and Drug Administration’s approval of Recarbio, a combination of three medications. A 2023 investigation by the medical journal The BMJ concluded that Recarbio was approved even though it had not demonstrated substantial evidence of clinical effectiveness.
Drugs Associated with Osteoporosis and Related Fractures
January 2024
Osteoporosis occurs when there is a decrease in bone mineral density and bone quality that can weaken bones, making them susceptible to fracture easily. Learn about drugs that are associated with osteoporosis and related fractures.
Patient Registries for Medicare Coverage of New Alzheimer’s Drugs
January 2024
Medicare will use patient registries to collect data about new Alzheimer’s drugs. Learn why the use of patient registries is not an effective means to determine whether patients are more likely to have their lives improved or worsened by these medications.
Respiratory Syncytial Virus (RSV) Vaccines for Adults Ages 60 and Older and to Protect Newborns
January 2024
Severe respiratory syncytial virus (RSV) infection is an important cause of hospitalization in the very old and the very young. Learn about two recently approved RSV vaccines.
How to Safely Buy Prescription Drugs Online
January 2024
Buying prescription medications from a licensed online pharmacy offers convenience and privacy and can save money. Learn what steps you can take to safely purchase prescription drugs online.
Donislecel for Brittle Type 1 Diabetes: Do Not Use
January 2024
In June 2023, the FDA approved donislecel (LANTIDRA) for the treatment of adults with type 1 diabetes who are unable to adequately control the disease because of repeated episodes of severe hypoglycemia, despite intensive management and education. Learn why Public Citizen’s Health Research Group has classified donislecel as a Do Not Use drug.
Meta-Analysis: Flu Drug Oseltamivir (TAMIFLU) Ineffective for Preventing Hospitalizations in Outpatients
December 2023
Although influenza (flu) is usually a self-limiting illness, severe cases require treatment in the hospital and some patients die. A recent meta-analysis, which assessed combined data from multiple prior studies, found that oseltamivir (TAMIFLU) was no better than placebo in reducing the rate of hospitalizations.
Enforcing Reporting Requirements for Clinical Trials
December 2023
In the U.S., sponsors of clinical trials are required to register the trials and report the results to ClnicalTrials.gov. Learn why the FDA , without further delay, should fully enforce the reporting requirements.
Review of Romosozumab (EVENITY) for Severe Postmenopausal Osteoporosis
December 2023
In 2019, the FDA approved romosozumab (EVENITY) for the treatment of osteoporosis in postmeopausal women who are at high risk of fractures (such as those who have had previous fractures) and for whom other osteoporosis therapies have not worked. Learn why Public Citizen’s Health Research Group has classified romosozumab as a Do Not Use drug.
FDA Advisory Committee: Over-the-Counter Oral Phenylephrine Is Not Effective for Relief of Nasal Congestion
December 2023
In 2022, people in the U.S. purchased as least 242 million over-the-counter products that contain oral phenylephrine at a cost of at least $1.8 billion. Learn why oral phenylephrine is not effective for the relief of nasal congestion and why the FDA should prioritize removal of over-the-counter oral phenylephrine products from the U.S. market.
Nonalcoholic Fatty Liver Disease: A Disease that Is Difficult to Treat
December 2023
Learn about nonalcoholic fatty liver disease (NAFLD), a condition in which excess fat accumulates in the liver, and the form of this disease known as nonalcoholic steatohepatitits (NASH), which is associated with inflammation of the liver and in some instances can lead to fibrosis, cirrhosis and liver failure. At present, there are no medications that have been approved by the FDA to treat either condition.
B Vitamins Do Not Protect Against Parkinson’s Disease, Long-Term Study Shows
November 2023
B vitamins have been proposed as a means to lower the risk of developing Parkinson’s disease. A recent study found that long-term dietary and supplemental intake of these vitamins was not associated with a lower risk of the disease.
The Beers Criteria: Helping to Protect Older Adults from Inappropriate Medication Use
November 2023
Learn about the Beers Criteria, which are used for determining potentially inappropriate medication use in people age 65 and older; the criteria have recently been updated.
Lifestyle Treatments to Prevent or Reduce the Frequency of Migraine Headaches
November 2023
Lifestyle changes not involving medications appear to offer some relief for people with recurrent migraine headaches. A recent review article assessed the evidence for changes related to stress management, sleep, diet and exercise. The review found that sleep-related issues were the only consistent lifestyle factor associated with migraine frequency.
PALFORZIA: A Burdensome Peanut-Allergen Drug With Serious Risks and Unknown Long-Term Benefits
November 2023
Palforzia, a peanut allergen protein powder, is an oral desensitization immunotherapy for children and adolescents (age four to 17 years) with a confirmed diagnosis of peanut allergy. Learn why Public Citizen’s Health Research Group has classified Palforzia as a Do Not Use drug.
Melatonin Gummies Sold in the U.S. Contain Inconsistent and Mostly Excessive Quantities of the Ingredient
November 2023
Melatonin, which is used to help with certain conditions such as jet lag and sleep-wake disorders, is regulated as a dietary supplement, not a drug. A recent study found that melatonin gummies sold in the U.S. contain inconsistent quantities of melatonin, and the quantity is usually higher than the amount listed on the product label.
Lecanemab for Alzheimer’s Disease: Do Not Use
October 2023
The FDA recently approved lecanemab (LEQEMBI) for patients with mild cognitive impairment and in the mild dementia stages of the disease. Learn why Public Citizen’s Health Research Group has classified lecanemab as a Do Not Use drug.
Improving Risk Information in Direct-to-Consumer Advertisements for Prescription Drugs
October 2023
In 2010, the FDA proposed a rule about the disclosure of risk information in television and radio direct-to-consumer advertisements of prescription drugs. Thirteen years later, and if the Office of Management and Budget allows the regulation to be finalized, the presentation of risk information about drugs advertised directly to consumers should improve.
Tirzepatide (MOUNJARO): Another Diabetes Drug Seeking FDA Approval for Weight Loss
October 2023
In 2022, the FDA approved tirzepatide (MOUNJARO) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Learn about the evidence for the use of tirzepatide for diabetes and chronic weight management. As of mid-September 2023, the FDA had not approved tirzepatide for chronic weight management.
Brexpiprazole: Do Not Use for Agitation Due to Alzheimer’s Dementia
October 2023
Brexpiprazole (REXULTI) is an atypical antipsychotic drug that the FDA initially approved as an adjunctive treatment to antidepressants for major depressive disorder. In 2023, the FDA extended the indications to include the treatment of agitation associated with dementia due to Alzheimer’s disease. Learn why Public Citizen’s Health Research Group has classified brexpiprazole as a Do Not Use drug for the treatment of Alzheimer’s disease-associated dementia.
Study Finds No Survival Differences Between Two Loop Diuretics Used in Heart Failure Patients
October 2023
A recent large adequately powered randomized clinical trial that directly compared furosemide and torsemide found that both drugs are equally effective in improving the survival of patients with heart failure.
News Brief: FDA Approves First Over-the-Counter Birth Control Pill in the United States
October 2023
A recent large adequately powered randomized clinical trial that directly compared furosemide and torsemide found that both drugs are equally effective in improving the survival of patients with heart failure.
Review Study Challenges Use of Antidepressants for Chronic Pain
September 2023
A review study, published earlier in 2023 in The BMJ, found limited evidence of low or moderate quality supporting the effectiveness of antidepressants for several conditions associated with chronic pain, including fibromyalgia, neuropathic pain and chronic tension headache.
The Persistent Problem of Drug Shortages in the United States
September 2023
Worst Pills, Best Pills News often highlights expensive drugs that have limited benefits and significant health risks. At the same time, some inexpensive and highly effective drugs are in such short supply that they are being rationed. The “From the Editor” column discusses the persistent problem of drug shortages in the United States.
Drug Interactions for the Antidepressant Drug Desipramine (NORPRAMIN)
September 2023
Patients taking the oral antidepressant drug desipramine (Norpramin) should be aware that it has clinically important interactions with many other prescription medications. Public Citizen’s Health Research Group has designated desipramine, a tricyclic antidepressant, as a Limited Use drug; antidepressants in other drug classes are safer and better tolerated.
Hydrochlorothiazide Not Better Than Placebo at Preventing Kidney Stones
September 2023
Thiazide diuretics often are prescribed to prevent recurrent kidney stones. However, a recent randomized, controlled trial found that hydrochlorothiazide was no better than placebo at preventing the recurrence of kidney stones.
Sofosbuvir for the Treatment of Chronic Hepatitis C Infection
September 2023
Learn about sofosbuvir, a highly effective antiviral medication that is used for chronic hepatitis C infection, alone or in combination with other antivirals.
Semaglutide (WEGOVY) for Weight Loss: Substantial Risks, Including Weight Regain
August 2023
Semaglutide, an injectable glucagon-like peptide-1 agonist, is having its moment as a drug for weight loss. Learn about the substantial risks of semaglutide, including weight regain if the medication is stopped.
FDA Approval of Brexpiprazole for Agitation Symptoms Associated With Dementia Due to Alzheimer’s Disease: A Concerning Decision
August 2023
The FDA has approved the antipsychotic medication brexpiprazole for agitation symptoms associated with dementia due to Alzheimer’s disease. Learn why Public Citizen’s Health Research Group urged the agency to reject the supplemental indication and why we believe that the drug’s small benefits do not outweigh its substantial risks.
Important Drug Interactions for the Stomach-Acid–Suppressing Drug Cimetidine
August 2023
Patients taking the stomach-acid–suppressing drug cimetidine, which is available over the counter as a generic, should be aware of its clinically important interactions with many other prescription medications.
Update: Oral Prescription Drugs Recalled Due to Nitrosamine Contamination
August 2023
The organic compounds known as nitrosamines are found in very low amounts in water and some foods; they may be carcinogenic to humans with exposure to high levels over a prolonged period. This article provides an update on oral prescription drugs recalled due to nitrosamine concentration.
Equal Effectiveness of Chlorthalidone and Hydrochlorothiazide for Treating Hypertension
August 2023
A recent clinical trial comparing chlorthalidone with hydrochlorothiazide found no difference between the two drugs in their effectiveness for preventing major cardiovascular events.
News Brief: Update on Screening for Anxiety Disorders
August 2023
In the article “Mindfulness as an Alternative to the Antidepressant Medication Escitalopram for Anxiety Disorder” in the July issue of Worst Pills, Best Pills News,[1] we discussed a draft recommendation for screening for anxiety disorders by the U.S. Preventive Services Task Force (USPSTF). Subsequently, the USPSTF finalized its recommendation to screen adults 64 years or younger for anxiety disorders. Citing insufficient evidence of benefit, the USPSTF did not recommend screening adults 65 years or older.[2] These recommendations may lead to more people seeking medical treatment for anxiety disorder. People with anxiety disorders should discuss with their clinicians whether nonpharmacological treatment options, such as psychotherapy or mindfulness-based interventions, are a good option.
Mindfulness as an Alternative to the Antidepressant Medication Escitalopram for Anxiety Disorder
July 2023
A recent study compared mindfulness to escitalopram (LEXAPRO), a commonly prescribed antidepressant medication, for patients diagnosed with an anxiety disorder. Although the study found that mindfulness meditation works, time and effort are needed to successfully complete the necessary mindfulness sessions and do regular home practice.
Insufficient Progress Against Liver Disease From Acetaminophen/Opioid Combination Products
July 2023
FDA regulatory action has limited the amount of acetaminophen in prescription drug products, including opioid combination products, to 325 mg per tablet. Although the agency’s actions have helped to reduce the frequency of liver damage from acetaminophen-and-opioid combination products, there is more work to be done.
No Proven Advantage for the New Combined Birth Control Pill Drospirenone and Estetrol (NEXTSTELLIS)
July 2023
A 28-day, fixed-dose, combined oral contraceptive marketed as NEXTSTELLIS has no proven advantage over older, well-studied, combined oral contraceptives. Public Citizen’s Health Research Group has designated Nextstellis as a Do Not Use medication, consistent with our designation of other drospirenone-containing combined oral contraceptives.
Two FDA-Approved Fecal Microbiota Products
July 2023
Learn about the two FDA-approved fecal microbiota products that are indicated only for adult patients with recurring Clostridioides difficile infection; the products are meant to help restore the gut microbiome. One product is administered by enema; the other product can be taken orally.
Update on Buprenorphine for the Treatment of Opioid-Use Disorder
July 2023
Treatment of opioid-use disorder is an important part of the public health response to the opioid epidemic in the United States. Learn about recent research that continues to support the effectiveness and safety of buprenorphine as a treatment for opioid-use disorder.
Liraglutide (SAXENDA): A Bad Weight-Loss Choice at Any Age
June 2023
Public Citizen’s Health Research Group has designated the chronic weight-management drug liraglutide (SAXENDA) as Do Not Use for all age groups. This article discusses the lack of strong evidence showing long-term, lasting and clinically meaningful benefits that outweigh the drug’s risks, both in obese adolescents and adults.
A New Editor for Worst Pills, Best Pills News
June 2023
Robert Steinbrook, M.D., the new Health Research Group Director at Public Citizen, introduces himself as the editor of Worst Pills, Best Pills News.
Important Drug Interactions for the Stomach-Acid–Suppressing Drug Rabeprazole (ACIPHEX)
June 2023
Patients taking the stomach-acid-suppressing drug rabeprazole (ACIPHEX) should be aware that it has clinically important interactions with many other prescription medications. Public Citizen’s Health Research Group has designated rabeprazole, a protein pump inhibitor, as Limited Use.
Drugs That Cause Sensitivity to Sunlight
June 2023
Some drugs, including commonly used prescription and over-the counter medications, can cause photosensitivity, increasing the skin’s vulnerability to sunlight. Nonsteroidal anti-inflammatory drugs and antibiotics are the drug classes with the strongest evidence for photosensitivity.
Postsurgical Gabapentin Use Increases Risk of Delirium, Antipsychotic Use and Pneumonia
June 2023
The seizure medication gabapentin (GRALISE, NEURONTIN) is used to treat postsurgical pain, but that approach is controversial because of concerns about effectiveness and safety. Recent research found that such use is associated with an increased risk of delirium, antipsychotic use and pneumonia in the postsurgical period.
Higher Risk of Withdrawal Symptoms With Antidepressants
May 2023
Learn about recent research assessing the risk of withdrawal symptoms following the discontinuation of antidepressants.
Key FDA Official at Center of Inappropriate FDA–Biogen Collaboration Finally Resigns
May 2023
The departure of the long-standing director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research — whose office was responsible for the review and accelerated approval of drugmaker Biogen’s aducanumab (ADUHELM) for treatment of Alzheimer’s disease — from the agency is a welcome, but long overdue, development.
Important Drug Interactions for the Antifungal Drug Voriconazole
May 2023
Patients taking the antifungal drug voriconazole (VFEND), which is marketed in both oral and injectable forms, should be aware that it has clinically important interactions with many other prescription medications.
Do Not Use: Olanzapine/Samidorphan (LYBALVI) for Schizophrenia or Bipolar I Disorder
May 2023
Public Citizen’s Health Research Group has designated olanzapine/samidorphan (LYBALVI) as Do Not Use because of questionable effectiveness and concerning safety data, especially because samidorphan use plausibly increases the risk of opioid overdose.
Timing of Once-Daily Blood Pressure Medications Does Not Influence Cardiovascular Outcomes, Study Finds
May 2023
Findings from a recent large-scale, well-designed clinical trial showed no greater benefit of evening dosing over morning dosing of once-daily antihypertensive medications in terms of major cardiovascular outcomes (such as heart attack and stroke).
Concentrated Insulin Glargine, TOUJEO: Limited Use for Diabetes
April 2023
As seven years have passed since Toujeo’s approval without new major safety concerns being identified, Public Citizen’s Health Research Group has now designated it as Limited Use — a treatment for diabetes that should be used only if treatment with less concentrated and cheaper forms of insulin have first been tried and found to be inadequate.
FDA Guidance on Homeopathic Drugs: An Ongoing Public Health Failure
April 2023
In his editor’s column, Dr. Carome explains why the FDA’s new guidance on homeopathic drugs fails to adequately address the public health threat posed by the agency’s decades-long permissive approach to these illegal drug products.
USPSTF Reaffirms Recommendations Against Using Menopausal Hormone Therapy to Prevent Chronic Conditions
April 2023
In this article, we discuss the U.S. Preventive Services Task Force’s recently updated recommendations against the use of menopausal hormone therapy to prevent chronic medical conditions, including cancer, heart disease, diabetes, dementia and stroke.
Review of Mavacamten, a New Drug for Hypertrophic Cardiomyopathy
April 2023
Learn why Public Citizen’s Health Research Group has designated the new heart drug mavacamten as Do Not Use for Seven Years.
Important Drug Interactions for the Hypertension Drug Felodipine
April 2023
Patients taking the commonly prescribed calcium channel blocker felodipine should be aware that it has clinically important interactions with many other prescription medications as well as the dietary supplement St. John’s wort.
News Brief: FDA Warns That Osteoporosis Drug May Be Linked to Severe Hypocalcemia in Certain Patients
April 2023
In this month’s news brief, we discuss the FDA’s November 2022 Drug Safety Communication about the agency’s ongoing evaluation of the risk of severe and symptomatic hypocalcemia in patients with advanced kidney disease, particularly those on dialysis, who received treatment with denosumab.
Drug and Food Interactions for the Thyroid Medication Levothyroxine
March 2023
Patients taking the widely prescribed hypothyroidism drug levothyroxine should be aware that it has clinically important interactions with many other prescription and over-the-counter medications, dietary supplements and even certain foods.
Congressional Probe Confirms Inappropriate FDA-Biogen Collaboration
March 2023
In his editor’s column, Dr. Carome discusses the disturbing findings of a scathing report issued by two U.S. House of Representatives committees about the inappropriately close collaboration between drugmaker Biogen and the FDA during the analysis of data from the key clinical trials of the Alzheimer’s disease drug aducanumab (ADUHELM).
“Do Not Use” Type 2 Diabetes Gliptin Drugs Also Raise Risk of Gallbladder Inflammation
March 2023
A recent study showed that, compared with other diabetes drugs, gliptins (or dipeptidyl peptidase 4 [DPP-4] inhibitors) put patients at a higher relative risk of a range of gallbladder or biliary diseases, such as gallstones (cholelithiasis) and gallbladder inflammation (cholecystitis).
Drug-Induced Insomnia
March 2023
Learn about the numerous prescription and over-the-counter medications that can cause or exacerbate insomnia.
Lithium Treatment for Bipolar Disorder May Protect Bones from Osteoporosis
March 2023
A recently published study provided evidence that lithium treatment in persons with bipolar disorder may decrease the risk of osteoporosis.
Routine Supplemental Vitamin D Does Not Prevent New Fractures in Healthy Midlife and Older Adults, Study Finds
February 2023
Data from a large, randomized clinical trial revealed that daily vitamin D supplementation does not lower the risk of new fractures in generally healthy community-dwelling people.
Lifesaving Insulin Remains Unaffordable for Too Many U.S. Patients
February 2023
In his editor’s column, Dr. Carome discusses the implications of new research documenting the extent of insulin rationing by diabetes patients in the United States due to Big Pharma’s relentless price gouging.
New Study Supports Our “Do Not Use” Designation for Rosuvastatin
February 2023
Learn about a new study showing that patients taking rosuvastatin (CRESTOR, EZALLOR SPRINKLE) had a higher risk of proteinuria (abnormal levels of protein in the urine) and hematuria (blood in the urine) than those taking another statin, atorvastatin (LIPITOR).
Important Drug Interactions for the Antidepressant Nortriptyline (PAMELOR)
February 2023
Patients taking the frequently prescribed antidepressant nortriptyline (PAMELOR) should be aware that it has clinically important and potentially dangerous interactions with many other prescription and over-the-counter medications.
Tofacitinib (XELJANZ, XELJANZ ER) for Rheumatoid Arthritis Increases Risk of Infections
February 2023
A recently published study confirmed that tofacitinib (XELJANZ, XELJANZ ER) increases the risk of severe and other infections compared to treatment with the tumor necrosis factor blocker drugs that demonstrate similar effectiveness for treating rheumatoid arthritis.
Review of the Chronic Heart Failure Combination Drug Sacubitril and Valsartan (ENTRESTO)
January 2023
Given the risks associated with Entresto, Public Citizen’s Health Research Group has classified it as Limited Use, to be used only in adults with heart failure with reduced ejection fraction.
Congress Reauthorizes FDA-Corrupting Prescription-Drug User Fees
January 2023
In his editor’s column, Dr. Carome explains how the FDA’s reliance on user fees from prescription drug manufacturers has resulted in corporate capture of the agency.
Overdose and Mental Health Crisis Common Long After Initiation of Opioid Tapering, Study Finds
January 2023
Learn about new research showing that increased rates of overdose and mental health crises persist during the second year after initiation of opioid tapering among patients taking stable, long-term, high-dose prescriptions of these medications.
Important Drug Interactions for Sotalol
January 2023
Patients taking the drug sotalol (BETAPACE, BETAPACE AF, SORINE, SOTYLIZE) should be aware that it has clinically important and potentially dangerous interactions with many other prescription medications.
Combination of Specific Dietary Supplements Can Slow Macular Degeneration Progression
January 2023
Age-related macular degeneration is a leading cause of vision loss in older adults. Find out which patients with this condition can benefit from a combination of specific dietary supplements known as AREDS2.
Update on How to Safely Dispose of Unused Opioids and Other High-Risk Drugs
December 2022
Given the serious risks of opioids, it is critical to dispose of any unused doses as soon as there is no longer a medical need for them. Learn how to do so safely by following the recommendations of the FDA.
New Bill Would Resurrect Proposed FDA Safety Rule on Generic-Drug Labeling
December 2022
The need for a rule that would allow generic-drug companies to promptly update safety warnings in their product labeling is more critical than ever given that approximately 90% of all prescriptions dispensed in the U.S. are generic medications and the reality that new information about serious risks often comes to light after generic versions of a drug come on the market.
USPSTF Recommendations for Initiating Regular Aspirin Use for Primary Prevention of Cardiovascular Disease
December 2022
Learn about the U.S. Preventive Services Task Force’s (USPSTF’s) updated recommendations regarding the use of daily aspirin to prevent heart attacks and strokes in patients without signs, symptoms or history of cardiovascular disease.
Important Drug Interactions for the SSRI Medication Fluvoxamine
December 2022
Patients taking fluvoxamine (LUVOX), a selective serotonin reuptake inhibitor (SSRI), should be aware that it has clinically important interactions with many other prescription and over-the-counter medications.
Erectile Dysfunction Drugs Increase Risk of Rare, Serious Adverse Ocular Events
December 2022
Recently published research provides the strongest evidence to date that erectile dysfunction drugs increase the risk of rare, serious adverse ocular events that can lead to vision loss.
News Brief: Pediatric Ingestion of Melatonin Is Increasing
December 2022
In this month’s news brief, we discuss a recently published study showing that in 2020, melatonin became the most frequently ingested substance among children and young adults reported to poison control centers in the U.S.
Very Low Risk of Heart Inflammation With COVID-19 mRNA Vaccines
November 2022
Data from a recently published large observational study confirm that myocarditis and pericarditis are rare but usually reversible adverse effects associated with COVID-19 messenger RNA vaccination.
Congress Finally Passes Legislation to Make Drugs More Affordable for Medicare Patients
November 2022
In his editor’s column, Dr. Carome discusses the major provisions of the recently enacted Inflation Reduction Act of 2022 that will help make prescription drugs more affordable for Medicare patients.
Drug-Induced Psychotic Symptoms, Including Hallucinations
November 2022
Learn about the numerous prescription medications and some over-the-counter drugs that can cause psychotic symptoms, including hallucinations.
Study Links Use of Sodium-Containing Oral Acetaminophen (TYLENOL) Formulations to Increased Risk of Cardiovascular Disease
November 2022
New research reveals that use of certain acetaminophen products that contain significant amounts of sodium is associated with an increased risk of developing cardiovascular disease and high blood pressure.
Important Drug Interactions for the Potassium-Sparing Diuretic Spironolactone
November 2022
Patients taking the commonly prescribed diuretic spironolactone should be aware that it has clinically important interactions with many other commonly used prescription and over-the-counter medications.
Contrary to Guidelines, Corticosteroids Commonly Used Outside of Hospitals to Treat COVID-19
October 2022
The use of corticosteroids in patients with mild-to-moderate COVID-19, who are typically treated at home and do not require oxygen therapy, is not beneficial and can be harmful. Disturbingly, a recent study shows that substantial proportions of nonhospitalized COVID-19 patients were prescribed systemic steroids.
FDA Fails to Protect Consumers From Dangerous Dietary Supplements
October 2022
To better protect consumers, the FDA must ensure that dietary-supplement makers who receive FDA warning letters promptly and permanently cease marketing illegal supplements that endanger consumers’ health.
Important Drug Interactions for the Antidepressant Citalopram (CELEXA)
October 2022
Patients taking the commonly prescribed antidepressant citalopram should be aware that it has clinically important and potentially dangerous interactions with many other prescription and over-the-counter medications.
Treating Lyme Disease: Antibiotics Are Usually Effective
October 2022
Lyme disease is the most common insect-borne illness, accounting for over half of all such disease. In this article, we discuss antibiotics that are routinely used to treat this infection.
No Added Pain-Relief Benefit With Use of the Psychotropic Drug Duloxetine (CYMBALTA, DRIZALMA SPRINKLE) in Osteoarthritis Patients, Study Shows
October 2022
In support of our position against the use of duloxetine to treat osteoarthritis patients, a new study fails to show any benefit for adding the drug to usual care in primary care settings among hip or knee osteoarthritis patients with chronic pain.
News Brief: FDA Warns of Serious Adverse Effects, Possible Increased Risk of Death With Cancer Drug Duvelisib
October 2022
In this month’s news brief, we discuss a recent FDA warning about serious adverse effects associated with the use of the cancer drug duvelisib.
Trial Shows Short Antibiotic Course Superior to Standard Longer One in Children With Nonsevere Pneumonia
September 2022
Results of new research funded by the National Institutes of Health reveals that otherwise healthy, young children with uncomplicated community-acquired pneumonia generally do well with a five-day antibiotic course as long as they are monitored for continued improvement.
New Legislation Would Compel FDA to Finalize Long-Overdue Rule on TV Prescription-Drug Ads
September 2022
Given the endless barrage of prescription-drug ads on TV, it is imperative that Congress immediately pass the Misleading Drug Ads Act to help ensure that consumers are not misled by TV ads that cleverly downplay the risks of prescrip¬tion medications while hyping the benefits.
New Insomnia Medication is More of the Same: Limited Efficacy With Serious Safety Concerns
September 2022
Learn why we have designated the recently approved insomnia drug daridorexant (QUVIVIQ) as Do Not Use.
Important Drug Interactions for the Cholesterol-Lowering Drug Pravastatin
September 2022
Patients taking the cholesterol-lowering drug pravastatin should be aware that it has clinically important interactions with many other prescription medications.
News Brief: FDA Warns Consumers Not To Use Products Marketed for Removing Moles and Other Common Skin Lesions
September 2022
In this month’s news brief, we discuss a recent FDA consumer advisory urging people not to use products that are marketed for the removal of moles and other skin lesions — such as seborrheic keratoses and skin tags — because of the risk of potentially dangerous adverse effects.
Drug-Induced Urinary Incontinence
September 2022
Numerous prescription and over-the-counter drugs can cause or exacerbate urinary incontinence. Knowing which medications prescribed or recommended by your doctor cause urinary incontinence will allow you to take steps to prevent or minimize this common, troubling adverse drug effect.
Routine Monthly High-Dose Vitamin D Supplementation Does Not Reduce Mortality in the Elderly, Trial Shows
August 2022
New research reveals that routine supplementation with high-dose vitamin D in older adults who are not vitamin D deficient is unlikely to reduce either overall mortality or cardiovascular mortality.
FDA Increasingly Reluctant to Seek Input From External Experts Before Approving New Drugs
August 2022
In his editor’s column, Dr. Carome discusses results of a recently published study that revealed a stunning drop over the past decade in the proportion of new drugs approved by the FDA each year that were referred to an advisory committee.
Important Drug Interactions for the Combination Antiviral COVID-19 Drug PAXLOVID
August 2022
Patients taking the oral combination antiviral drug PAXLOVID (nirmatrelvir and ritonavir), which is used to treat COVID-19, should be aware that it has clinically important and potentially dangerous interactions with many other prescription medications.
Medications May Be Carefully Discontinued If Obsessive-Compulsive Disorder Remits
August 2022
A recent clinical trial indicates that many persons with obsessive-compulsive disorder who respond favorably to joint behavioral and drug treatment may then safely taper their medication use very slowly to elimination, though careful follow-up clinical monitoring is still essential.
Trial Compares Titrated Treatment With Two Gout Drugs: Allopurinol and Febuxostat
August 2022
Learn about the results of a new clinical trial funded by the Department of Veterans Affairs that compared the safety and effectiveness of allopurinol and feboxostat for treatment of gout.
Drug-Induced Sexual Dysfunction in Women
July 2022
Medications are a leading cause of sexual dysfunction in women. Knowing which drugs prescribed or recommended by your doctor can cause sexual dysfunction will allow you to take steps to prevent or minimize this common, often troubling adverse drug effect.
Congress Must Heed Public’s Demand for Comprehensive Drug-Pricing Reform
July 2022
Americans clearly are fed up with the relentless price-gouging practices of the pharmaceutical industry and want Congress to finally pass legislation that would comprehensively reform drug pricing in the U.S. Patients cannot afford any further inaction by Congress on this issue.
FDA Warns That Buprenorphine Medications Dissolved in Mouth Increase Risk of Dental Problems
July 2022
In January 2022, the FDA warned that dental problems have been reported in patients using buprenorphine-containing tablets and films that are taken by dissolving them in the mouth. These problems have included tooth decay, cavities, oral infections and loss of teeth.
Reassuring Findings About Switching Among Generic Versions of the Thyroid Drug Levothyroxine
July 2022
Findings from a new retrospective, real-world observational study that assessed switching among the most common generic levothyroxine products made by different manufacturers in the U.S. suggest that switching among these products is unlikely to have a substantial impact on treatment effects.
Some Antipsychotics Elevate Breast Cancer Risk, a Large Study Confirms
July 2022
Many studies have suggested that breast cancer risk, via prolactin elevation, is increased by antipsychotic medications, but the results were mixed and warranted further, more rigorous investigation. A recent, large observational study has added stronger evidence that certain antipsychotic medications increase breast cancer risk.
News Brief: FDA Issues Warning Letters to Companies Selling Unapproved Over-The-Counter Skin-Lightening Drug Products
July 2022
In this month’s news brief, we discuss recent warning letters issued by the FDA to 12 companies for selling illegal over-the-counter drug products intended for skin lightening. The FDA noted that such products can cause serious adverse effects, including permanent discoloration of the skin.
Review of the Triptan Drugs for Treating Migraines
June 2022
Public Citizen’s Health Research Group recommends that triptans only be used to treat migraine headaches after determining that acetaminophen or nonsteroidal anti-inflammatory drugs fail to work or cannot be taken due to allergies or other medical reasons.
CMS Makes the Right Call, Restricts Medicare Coverage for Unproven Alzheimer’s Disease Drug
June 2022
In his editor’s column, Dr. Michael Carome explains why Medicare officials’ April decision to restrict coverage for aducanumab to patients enrolled in clinical trials is a win for patients, Medicare beneficiaries, the American taxpayer and evidence-based medicine.
Important Drug Interactions for Quinidine
June 2022
Patients taking the drug quinidine should be aware that it has clinically important and potentially dangerous interactions with many other prescription medications.
Drug-Induced Gallstones (Cholelithiasis)
June 2022
Learn about several drugs that can promote the formation of gallstones — stones in the gallbladder (a condition known as cholelithiasis) — and what you can do about it.
To Quit Smoking, Combination or Long-Duration Varenicline Is Not the Answer
June 2022
Recently published research revealed that combination therapy with varenicline (CHANTIX) and a nicotine patch (HABITROL, NICODERM CQ) is no better than varenicline alone as a method to quit smoking.
Study Highlights Many Adults Use Potentially Blood-Pressure–Raising Drugs
May 2022
Hypertension is a major risk factor for heart disease and stroke. Results of new research showing that many people, including many being treated for hypertension, are taking medications that can raise their blood pressure.
Large-Scale Pharmacy Compounding Remains a Potential Danger
May 2022
A recent FDA inspection of a compounding pharmacy engaged in large-scale production of sterile drugs identified dangerous unsanitary conditions that pose a clear and present danger to patients.
Important Drug Interactions for NSAIDs
May 2022
Patients taking any of the widely used nonsteroidal anti-inflammatory drugs (NSAIDs) should be aware that they all have clinically important interactions with many other medications.
Study Links Hip Steroid Injections to Rapidly Destructive Hip Disease
May 2022
Some patients with hip pain due to osteoarthritis chose to undergo steroid injections into the hip joint. Evidence from a recent observational study shows that such intra-articular steroid injections are associated with an increased risk of rapidly destructive hip disease, a serious long-term condition that involves rapid joint destruction and bone loss.
Low-Dose Aspirin Recommended for Prevention of Preeclampsia in High-Risk Pregnant Women
May 2022
Learn why the U.S. Preventive Services Task Force continues to recommend the use of low-dose aspirin to prevent preeclampsia in expectant mothers at high risk for the disorder.
Question and Answer
May 2022
In this month’s Question and Answer, we respond to a reader’s question about whether patients with impaired kidney function should avoid taking bisphosphonates for treatment of osteoporosis.
Review of the Gastrointestinal Drug Metoclopramide (GIMOTI, REGLAN)
April 2022
Learn about the serious adverse effects caused by the gastrointestinal drug metoclopramide, which we have designated as a Limited Use drug.
Lax FDA Oversight Fostered Surge in Unproven Stem Cell Treatments
April 2022
In order to protect patients and public health, the FDA must take swift and aggressive enforcement actions against stem cell clinics that continue to manufacture or market stem cell products without the necessary FDA approval or substantial evidence of safety and effectiveness from rigorous clinical trials.
Drug-Induced Sexual Dysfunction in Men
April 2022
Medications are a leading cause of sexual dysfunction in men. Knowing which drugs prescribed or recommended by your doctor can cause sexual dysfunction will allow you to take steps to prevent or minimize this common, often troubling adverse drug effect.
NSAIDs Better Than Opioids for Pain Control Following Hospitalization or Minor Surgery
April 2022
Recently published research strongly suggests that treatment of acute pain after hospitalization or after outpatient dental surgery is best achieved with nonsteroidal anti-inflammatory drugs (NSAIDs) rather than opioids.
The Antidepressant Mirtazapine Ineffective for Agitation in Dementia Patients, Study Shows
April 2022
A new well-designed study conducted by U.K. researchers found that mirtazapine is not beneficial for treating agitated behaviors in dementia patients and is potentially linked to an increased risk of death.
Certain Commonly Used Oral Drugs Tainted With Cancer-Causing Nitrosamine Impurities
March 2022
Learn whether any of the drugs you are taking have been recalled due to contamination with cancer-causing nitrosamines and, if so, what steps you should take.
Big Pharma’s “Unjustified and Unfair” Business and Pricing Practices
March 2022
In December 2021, the U.S. House of Representatives’ Committee on Oversight and Reform issued a final report documenting a wide range of egregious business practices that have resulted in ever-increasing price gouging of American consumers and the Medicare program by Big Pharma.
Medications That Cause Diarrhea
March 2022
More than 700 medications have been implicated in inducing diarrhea, accounting for nearly 7% of all adverse drug events. Knowing which medications prescribed or recommended by your doctor cause diarrhea will allow you to take steps to prevent or minimize this common adverse drug effect.
Important Drug Interactions for Angiotensin Receptor Blockers
March 2022
Patients taking any of the widely prescribed angiotensin receptor blockers used to treat hypertension, among other disorders, should be aware that they have clinically important interactions with many other commonly used prescription and over-the-counter medications.
Cannabidiol Treatment Is Ineffective for Arthritic Pain
March 2022
Despite the suggestion that cannabidiol may have pain-relieving or anti-inflammatory effects, the totality of the evidence thus far has led international experts to conclude that this substance should not be recommended for pain management. Results of a recently published clinical trial reinforce that conclusion by showing that cannabidiol is ineffective as a treatment for arthritis pain.
A Review of the Shingles Vaccine SHINGRIX
February 2022
Learn why the recombinant zoster vaccine SHINGRIX is the right choice for preventing the viral infection herpes zoster — commonly known as shingles — as well as serious long-term complications of the infection.
Alzheimer’s Drug Aducanumab Causes Medicare Part B Premium Sticker Shock for All Beneficiaries
February 2022
To protect Medicare beneficiaries from skyrocketing premiums and deductibles, the Centers for Medicare and Medicaid Services must promptly announce that it will not cover the unaffordable Alzheimer’s disease drug aducanumab (ADUHELM) under the Medicare program until there is definitive evidence that the drug provides substantial cognitive benefit to Alzheimer’s disease patients.
Important Drug Interactions for the Antidepressant Fluoxetine (PROZAC, SYMBYAX)
February 2022
Patients taking the commonly prescribed antidepressant fluoxetine should be aware that it has clinically important and potentially dangerous interactions with many other prescription and over-the-counter medications.
Magnesium Is Best Obtained From Dietary Sources, Not Supplements
February 2022
It is estimated that more than a quarter of adult Americans take a magnesium supplement. However, preference should be given to relying on dietary sources of this critical mineral whenever possible to avoid adverse effects.
Fluoxetine (PROZAC) Not Effective for Preventing Depression Following a Stroke
February 2022
Results of a large, well-designed, randomized clinical trial recently published in a leading medical journal provided strong evidence that the commonly prescribed selective serotonin reuptake inhibitor antidepressant fluoxetine was not effective for preventing depression in the first six months after a stroke.
The Antiparasitic Drug Ivermectin Is No “Silver Bullet” for COVID-19, Current Evidence Shows
January 2022
This article summarizes the current evidence on the use of ivermectin for treatment of COVID-19, which does not support its use for this purpose.
Biden’s Recycled FDA Commissioner Pick: Still Unfit for Duty
January 2022
The country desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry. Dr. Robert Califf would not be that leader.
Drug-Induced Constipation
January 2022
Numerous prescription and over-the-counter drugs can cause or exacerbate constipation. Knowing which medications prescribed or recommended by your doctor cause constipation will allow you to take steps to prevent or minimize this common, troubling adverse drug effect.
FDA Limits Approved Uses of Tofacitinib (XELJANZ, XELJANZ XR) Because of Serious Adverse Effects
January 2022
Learn why the FDA has limited the approved uses and strengthened the product labeling warnings for the oral drug tofacitinib (XELJANZ, XELJANZ XR), which is approved for treatment of rheumatoid arthritis and certain other inflammatory diseases.
For Men With Urinary Tract Infections Without Fever, 7-Day Antibiotic Treatment Seems to Be Enough
January 2022
In this article, we discuss results of new research indicate that in men with acute UTIs and no fever, a 7-day course of oral antibiotics appears to be just as good for eradicating the infection as the commonly used 14-day course. Importantly, shorter courses of treatment can reduce the risk of adverse effects of antibiotic therapy.
News Brief: FDA Update Highlights Risk of Accidental Child Exposure to Fentanyl Patches
January 2022
In this month’s news brief, we discuss the FDA’s recent consumer alert warning that children who are accidentally exposed to fentanyl transdermal patches, know by the brand name DURAGESIC, are at risk of life-threatening overdose, even after the patches have been used for the typical full three days.
Why You Should Avoid the Herbal Supplement St. John’s Wort
December 2021
Learn why we have designated St. John’s wort, an herbal dietary supplement that is commonly available in capsules, tablets or teas, as Do Not Use.
Prescription-Drug Price Gouging in U.S. Fuels Big Pharma’s Revenues
December 2021
In his editor’s column, Dr. Michael Carome highlights a new Public Citizen report that provided a glimpse of how much Big Pharma benefits from the American health care system overpaying for drugs.
FDA Warns Abuse and Misuse of Over-the-Counter Nasal Decongestant Propylhexedrine (BENZEDREX) Causes Serious Harm
December 2021
The FDA issued a Drug Safety Communication warning that abuse and misuse of the over-the-counter nasal decongestant drug propylhexedrine, a stimulant, can cause serious harm, including heart and mental health problems.
Vitamin D Supplementation Does Not Prevent Depression
December 2021
In this article, we review results of a recent randomized trial that found vitamin D supplementation was not useful for preventing depression in relatively healthy adults.
A Guide to Treatment for ADHD in Children and Adolescents
December 2021
In this article, we review the process for diagnosing attention deficit hyperactivity disorder (ADHD) in children and adolescents and evaluate the available treatment options for managing it.
News Brief: FDA Warns That Hand-Sanitizer Vapors Can Cause Adverse Effects
December 2021
In this month’s news brief, we discuss the FDA’s recent waring that over-the-counter alcohol-based hand sanitizers, especially if used in enclosed spaces or poorly ventilated locations, can cause headaches, nausea and dizziness.
Potassium: An Essential but Often Overlooked Nutrient
November 2021
Learn about the health benefits of consuming an adequate amount of dietary potassium. To help readers assess their potassium intake, we offer a list of potassium-rich foods.
When It Comes to Improving Your Memory, Forget About Prevagen
November 2021
In his editor’s column, Dr. Michael Carome explains why you should mute your TV when you see ads for the dietary supplement apoaequorin (PREVAGEN) and avoid being duped into buying this worthless supplement.
Important Drug Interactions for the Antifungal Drug Itraconazole
November 2021
Patients taking the oral antifungal drug itraconazole (SPORANOX, TOLSURA) should be aware that it has clinically important interactions with many other prescription medications that can affect the safety or effectiveness of itraconazole or the interacting drugs.
Low- and Regular-Dose Aspirin Equally Effective for Preventing Cardiovascular Disease, Trial Shows
November 2021
In this article, we discuss the results of a randomized clinical trial that compared low- and regular-dose aspirin for preventing another heart attack or stroke in patients with known atherosclerotic cardiovascular disease.
10 Rules for Safer Drug Use
November 2021
Patients often wonder what steps they can take to minimize their chances of suffering a serious adverse drug reaction. This article reviews 10 simple rules developed by Public Citizen’s Health Research Group for ensuring safer drug use.
Oral Bisphosphonates for Osteoporosis: Important Warnings
October 2021
Patients taking bisphosphonates need to know that these drugs are associated with a wide range of potentially serious adverse effects.
Inspector General to Probe FDA Approval of Alzheimer’s Disease Drug
October 2021
Finally, after months of foot-dragging, the Department of Health and Human Services’ Office of Inspector General has heeded our call for an investigation into the unprecedented and inappropriately close collaboration between Biogen and the FDA during the analysis of data from the key clinical trials of aducanumab (ADUHELM) for treatment of Alzheimer’s disease, which dangerously compromised the integrity of the FDA’s review of the drug.
Drug-Induced Hair Loss
October 2021
Learn about some of the commonly used medications that may lead to hair loss, also known as alopecia.
Study Shows Fasting and Heavy Drinking Associated With Liver Injury After Standard Acetaminophen Doses
October 2021
In this article, we discuss new research showing that prolonged use of acetaminophen at recommended dosages in conjunction with excessive drinking or fasting may lead to catastrophic liver failure.
Important Drug Interactions for the Stomach-Acid–Suppressing Drugs Lansoprazole and Dexlansoprazole
October 2021
Patients taking the commonly used stomach-acid–suppressing drugs lansoprazole (PREVACID, PREVACID 24 HR) and dexlansoprazole (DEXILANT) should be aware that these drugs have clinically important interactions with many other prescription medications.
Drug for Treating Nighttime Urination Too Dangerous
September 2021
Learn why Public Citizen’s Health Research Group has designated desmopressin sublingual tablets (NOCDURNA) as Do Not Use.
Direct-to-Consumer Advertising May Be Driving Up Medicare Drug Spending
September 2021
A recent Government Account¬ability Office report found that direct-to-consumer prescription-drug advertising may be a major factor contributing to rising spending on medications by the Medicare program and its beneficiaries.
Levothyroxine Ineffective for Depressive Symptoms in Elderly Patients With Subclinical Underactive Thyroid
September 2021
In this article, we discuss the results of a recent rigorously conducted study showing that therapy with the thyroid-hormone drug levothyroxine in older adults with subclinical hypo-thyroidism (a mild form of underactive thyroid) who had depressive symptoms provided no significant benefit.
Medications That Cause Gastrointestinal Bleeding
September 2021
Gastrointestinal bleeding is a common cause of hospitalization and in severe cases can result in death. Find out which commonly used medications can cause gastrointestinal bleeding.
Despite Big Risks, Dementia Patients Often Prescribed Multiple Psychoactive Drugs
September 2021
New research reveals marked overuse of central nervous system-active medications in dementia patients despite the substantial risks, including an increased risk of premature death.
High-Dose Vitamin C and Zinc Supplements Ineffective for COVID-19 Treatment, Trial Shows
August 2021
Unfounded claims about the supportive roles of vitamin C and zinc for treating COVID-19 infection have led to increased demand and expenditures for these supplements, among others. Evidence from a recent study that was conducted by Cleveland Clinic researchers refutes these claims.
FDA’s Reckless Decision to Approve Aducanumab for Alzheimer’s Disease
August 2021
In his editor’s column, Dr. Michael Carome discusses why the FDA’s June approval of Biogen’s monoclonal-antibody drug aducanumab (ADUHELM) for the treatment of Alzheimer’s disease was one of the worst decisions in the agency’s history.
Quitting Smoking: Behavioral Therapy and Medications Can Help
August 2021
In this article, we discuss the most recent smoking-cessation recommendations from the U.S. Preventive Services Task Force and the underlying research supporting these recommendations.
Important Drug Interactions for the Hypertension and Angina Drug Nifedipine
August 2021
Patients taking the widely prescribed calcium channel blocker nifedipine (PROCARDIA, PROCARDIA XL) should be aware that it has clinically important interactions with many other prescription medications.
Critiquing Evidence About the Risky Arthritis and Pain Drug Celecoxib (CELEBREX, CONSENSI)
August 2021
Learn why we have designated celecoxib, a widely used selective COX-2 inhibitor that belongs to a drug class called nonsteroidal anti-inflammatory drugs, as Do Not Use.
New FDA Warning About Heart, Cancer Risks for Tofacitinib (XELJANZ)
July 2021
In this article, we discuss an important new warning issued by the FDA about preliminary results from a safety clinical trial that showed increased risks of serious heart-related adverse effects and cancer in rheumatoid arthritis patients taking the oral drug tofacitinib.
Numerous Companies Cited for Promoting Bogus COVID-19 Cures
July 2021
In his editor’s column, Dr. Michael Carome advises readers to remain vigilant for businesses peddling COVID-19 products that are fraudulent, a waste of money and potentially harmful.
Important Drug Interactions for the Abnormal Heart Rhythm Drug Amiodarone
July 2021
Patients taking the commonly prescribed abnormal heart rhythm drug amiodarone should be aware that it has clinically important interactions with many other prescription medications.
FDA Needs to Quickly Ban the Illegal Opioid-Like Substance Tianeptine
July 2021
Learn why tianeptine — an addictive synthetic chemical compound that has led to abuse, physical dependence and withdrawal adverse reactions similar to those of opioids — has emerged as a growing public health threat in the U.S. and internationally.
Important Information in Prescription Drug Labels
July 2021
Knowledge about key information found in a prescription drug’s professional label can be an important tool for consumers seeking to improve their health while avoiding drug-induced injuries.
Question & Answer
July 2021
In this month’s Question & Answer, we respond to a reader’s question about what steps can be taken to prevent or manage common adverse reactions due to COVID-19 vaccines.
Important Drug Interactions for the Antibiotic Erythromycin
June 2021
Patients taking the commonly prescribed antibiotic erythromycin should be aware that it has clinically important interactions with many other prescription medications.
Some Hand Sanitizers Tainted With Benzene, a Known Human Carcinogen
June 2021
In his editor’s column, Dr. Michael Carome lambasts the FDA for its policy that allowed some hand sanitizers to be marketed in the U.S. during the COVID-19 pandemic that were tainted with carcinogenic benzene.
Omega-3 Fatty Acid Supplements Not Beneficial for Reducing Cardiovascular Events, Trials Show
June 2021
Learn why taking daily oral omega-3 fatty oral supplements containing a combination of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) may not be good for your heart.
Serious Adverse Effects Associated With Short-Term Use of Oral Corticosteroids
June 2021
In this article, we review data from new research showing that even short-term (14 or fewer days) use of oral corticosteroids can increase your risk of serious adverse effects.
Proton Pump Inhibitors Associated With Increased Risks of Fractures and Asthma in Children
June 2021
Results of recently published studies suggest that use of the potent stomach-acid–suppressing proton inhibitor medications in children may lead to small increases in the risks of fractures and asthma.
News Brief: Easy-to-Swallow Acetaminophen Tablets Pose Danger to Young Children
June 2021
In this month’s News Brief, we discuss a recent safety advisory issued by drug regulators in Canada warning of multiple reports of children experiencing acetaminophen poisoning after ingesting adult acetaminophen easy-to-swallow tablets that look like candy.
Overview of the Blood Thinner Rivaroxaban (XARELTO): An Update
May 2021
Learn why we have designated rivaroxaban, one of the so-called “novel” oral anticoagulants (blood thinners), as Do Not Use.
Merck, FDA Failed to Disclose Hair-Loss Drug’s Potential Suicide Risk
May 2021
In his editor’s column, Dr. Michael Carome discusses a troubling report that detailed how drugmaker Merck & Co. and the FDA failed to add a warning about the potential risk of suicidal thoughts in men taking the company’s anti-baldness drug PROPECIA to the drug’s U.S. product labeling.
FDA Belatedly Requires Abuse-Related Black-Box Warnings for Benzodiazepines
May 2021
In September 2020, the FDA announced that it would require the manufacturers of all benzodiazepines to update the black-box warning (the strongest warning that the agency can require) for these drugs to describe risks of abuse, addiction and other related adverse reactions. Such action was long overdue.
A Look at Cognitive Behavioral Therapy for Insomnia in Patients With Other Medical Conditions
May 2021
In this article, we review results of new research that examined a specific form of nondrug psychological therapy, referred to as cognitive behavioral therapy for insomnia, for management of chronic insomnia in patients with other major physical or mental disorders.
Drugs That Cause Neuroleptic Malignant Syndrome
May 2021
Neuroleptic malignant syndrome is a life-threatening neurological disorder most often caused by neuroleptic (antipsychotic) medications, which are used to treat schizophrenia and certain other psychiatric disorders, among other things. The syndrome also can be caused by certain other drugs used to treat nausea and depression, as well as by the sudden discontinuation of a dopamine agonist (drugs that are used most commonly to treat Parkinson’s disease).
Question & Answer
May 2021
In this month’s Question & Answer feature, we respond to a reader’s question about whether the potassium-sparing diuretic spironolactone (ALDACTONE, CAROSPIR) can cause magnesium deficiency.
New Research Shows Bisphosphonates Prevent Osteoporosis-Related Hip Fractures
April 2021
Recently published research demonstrated that bisphosphonate drugs are useful for preventing osteoporosis-related hip fractures, but that continuous bisphosphonate therapy beyond five years appears to offer no additional benefit for preventing such fractures.
COVID-19 Pandemic Cripples FDA’s Drug-Manufacturing Inspections
April 2021
According to a troubling report issued in January by the Government Accountability Office — an independent, nonpartisan federal watchdog agency that works for Congress — the COVID-19 pandemic has caused severe reductions in the FDA’s entire inspection program, with inspections of foreign drugmakers brought to a virtual standstill.
Important Drug Interactions for Cholesterol-Lowering Drug Atorvastatin (LIPITOR)
April 2021
Patients taking the commonly prescribed drug atorvastatin, which is a member of the statin family of cholesterol-lowering drugs, should be aware that it has clinically important interactions with many other prescription medications.
New Research: Safe to Continue Commonly Used Hypertension Drugs in COVID-19 Patients
April 2021
Soon after the coronavirus pandemic began, theoretical concerns were raised about the possibility that the widely prescribed angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) may increase the risk of contracting the coronavirus and predispose COVID-19 patients to more severe illness. Results of a randomized controlled trial provide new evidence that ACE inhibitors and ARBs can be safely continued in patients hospitalized with COVID-19.
Overview of the Unproven Blood-Thinner–Reversal Drug Idarucizumab (PRAXBIND)
April 2021
Idarucizumab (PRAXBIND) received accelerated approval from the FDA in 2015 for reversal of the effect of the new oral anticoagulant (blood thinner) dabigatran (PRADAXA) when needed before emergency surgery or urgent procedures or in life-threating or uncontrolled bleeding. Learn why we have designated idarucizumab and dabigatran as Do Not Use.
Question & Answer
April 2021
In this month’s Question & Answer feature, we respond to a reader’s question about whether we had any new information regarding the risks of allergic reactions in recipients for the two-dose Pfizer-BioNTech and Moderna messenger RNA COVID-19 vaccines.
Research Not Supportive of Taking Low-Dose Aspirin Solely for Cancer Prevention
March 2021
In this article, we discuss key evidence supporting the conclusion that low-dose aspirin should not be used for the sole purpose of preventing any type of cancer, an indication for which the drug is not approved by the FDA.
Federal Watchdog Targets Pharma’s Paid Physician Speaker Programs
March 2021
In his editor’s column, Dr. Michael Carome applauds the U.S. Department of Health and Human Services Office of Inspector General (OIG) for issuing a “Special Fraud Alert” highlighting the “inherent risks” of illegal fraud associated with pharmaceutical and medical device com¬panies paying physicians and other health care professionals to speak at company-sponsored events.
Important Drug Interactions for the Seizure Drug Carbamazepine
March 2021
Patients taking the commonly prescribed epilepsy drug carbamazepine (CARBATROL, EPITOL, EQUETRO, TEGRETOL, TERIL) should be aware that it has clinically important interactions with numerous other prescription and over-the-counter medications.
New Research Shows Gabapentin Not Effective for Pelvic Pain in Women
March 2021
Gabapentin (NEURONTIN, HORIZANT, GRALISE) is frequently prescribed for uses not approved by the FDA (so-called off-label uses), especially for chronic pain. A recently published clinical trial of the drug for treatment of chronic pelvic pain in women underscores why such off-label use, which we oppose, should be avoided.
FDA Warns Against Using NSAIDs in Pregnancy at 20 Weeks or Later
March 2021
Learn why the FDA in October 2020 warned that pregnant women in general should avoid using nonsteroidal anti-inflammatory drugs (NSAIDs) at about 20 weeks or later in pregnancy because of the rare risks of pregnancy complications and serious harm to an unborn baby.
Question & Answer
March 2021
In this month’s Question & Answer feature, we respond to a reader’s question about whether the stomach-acid–suppressing drug esomeprazole (NEXIUM, NEXIUM 24HR, VIMOVO) has the same drug interactions as the closely related drug omeprazole (PRILOSEC, PRILOSEC OTC, ZEGERID).
Overview of the Questionable Drug Andexanet (ANDEXXA)
February 2021
Andexanet (ANDEXXA) received accelerated approval from the FDA for emergency reversal of life-threatening or uncontrolled bleeding caused by the use of two new oral anticoagulants: apixaban (ELIQUIS) and rivaroxaban (XARELTO). Learn why we have designated andexanet and these two anticoagulants as Do Not Use.
Our Current Views on the First Two FDA-Authorized COVID-19 Vaccines
February 2021
In his editor’s column, Dr. Michael Carome explains why we encourage readers eligible to receive either of the first two COVID-19 vaccines granted Emergency Use Authorizations by the FDA to get vaccinated when the vaccines become available.
Reformulated OxyContin Fails to Show Less Abuse 10 Years After FDA Approval
February 2021
In this article, we review four postmarketing studies Purdue Pharma submitted to the FDA that evaluated the alleged abuse-deterrent properties of the company’s reformulated OxyContin and the agency’s independent assessment of the studies’ results. The data failed to show any meaningful reductions in overall opioid abuse or overdoses since the reformulated Oxycontin was approved in 2010.
Drugs That Cause Magnesium Deficiency
February 2021
Magnesium deficiency, due to either inadequate dietary intake, impaired intestinal absorption or excessive urinary loss of the mineral, results in low blood magnesium levels — a condition known as hypomagnesemia — and a wide range of adverse health effects. Importantly, many commonly used drugs also can cause magnesium depletion.
High-Dose Biotin Supplements Can Cause Inaccurate Laboratory Test Results
February 2021
Dietary supplements that contain more than the recommended daily intake of biotin, also known as vitamin B7, can significantly interfere with many important clinical laboratory blood tests (including those for heart disease and thyroid problems), falsely altering their results. Incorrect test results can lead to misdiagnosis and inappropriate treatment of health conditions, which may have serious or even deadly consequences.
News Brief: Non-melanoma Skin Cancer Warning Added to Hydrochlorothiazide Drug Label
February 2021
In this month’s news brief, we report on FDA-required changes to the product labeling for hydrochlorothiazide (MICROZIDE), a thiazide diuretic drug (“water pill”), warning about a small increased risk of non-melanoma skin cancer associated with use of the drug.
Postmenopausal Women Should Not Use the Conjugated Estrogens and Bazedoxifene Combination (DUAVEE)
January 2021
We previously designated Duavee as “Do Not Use for Seven Years” because, at the time of its approval by the FDA in 2013, it did not represent a clear clinical breakthrough over standard hormone replacement therapy for postmenopausal women. Learn why we have now updated our designation of the drug to Do Not Use.
Tainted Hand Sanitizers Reinforce Need for FDA Drug-Recall Authority
January 2021
In his editor’s column, Dr. Michael Carome discusses how unscrupulous companies exploited pandemic-related shortages of hand sanitizers and consumer panic by marketing hand sanitizers that contained dangerous ingredients and thus violated regulatory standards established by the FDA.
Important Drug Interactions for Angiotensin-Converting Enzyme Inhibitors
January 2021
Patients taking the widely prescribed angiotensin-converting enzyme (ACE) inhibitors, such as benazepril (LOTENSIN) and lisinopril (PRINIVIL, QBRELIS, ZESTRIL), should be aware that these medications have clinically important interactions with many other prescription and over-the-counter medications.
Common Antidepressants Carry Very Small Risk of Birth Defects
January 2021
In this article, we review results of a new study that sheds further light on the association between the use of specific antidepressants during early pregnancy and the small risk of birth defects.
New Research Finds Commonly Used Gout Drug Not Useful for Slowing the Progression of Chronic Kidney Disease
January 2021
Results of two recently published large, well-designed, randomized clinical trials provide important new evidence against using allopurinol (LOPURIN, ZYLOPRIM) to slow the rate of kidney function decline in patients with chronic kidney disease, a use of the drug that is not approved by the FDA.
Alcohol and Benzodiazepines Commonly Co-Involved in U.S. Opioid Overdose Deaths, Study Finds
December 2020
Combining opioids with other central nervous system depressants — mainly alcoholic beverages or benzodiazepines — greatly increases the risk of opioid overdose and death. These dangers are highlighted by new research showing that alcohol and benzodiazepines were commonly co-involved in U.S. opioid overdose deaths in recent years.
Maker of “Female Viagra” Deceives Women With Misleading Radio Ad
December 2020
In his editor’s column, Dr. Michael Carome discusses a recent FDA warning letter to Sprout Pharmaceuticals accusing the company of airing of an illegal radio ad that made “false or misleading claims about the risks” associated with flibanserin (ADDYI) — a drug intended to increase sexual desire in premenopausal women with hypoactive (low) sexual desire disorder that is often erroneously dubbed the “female VIAGRA” and that we have designated as Do Not Use.
Dexamethasone: A Marginally Beneficial Treatment for Severe COVID-19
December 2020
In this article, we review the results of randomized clinical trials showing that the anti-inflammatory corticosteroid dexamethasone reduces the risk of death in patients hospitalized with COVID-19 who require supplemental oxygen or mechanical ventilation.
Important Drug Interactions for the Calcium Channel Blocker Diltiazem
December 2020
Patients taking the widely prescribed calcium channel blocker diltiazem (CARDIZEM, CARTIA XT, TAZTIA XT, TIAZAC) should be aware that it has clinically important interactions with many other prescription medications.
Liraglutide (SAXENDA): The Wrong Choice for Weight Loss
December 2020
Find out why the FDA-approved high-dose form of liraglutide, which was originally marketed at a lower dose for treatment of type 2 diabetes, is not a safe option for managing weight loss.
Question & Answer
December 2020
In this month’s Question & Answer feature, we respond to a reader’s question about whether the risks of montelukast (SINGULAIR) outweigh its benefits when it is used for chronic obstructive pulmonary disease (COPD).
Hydroxychloroquine and Chloroquine: Failed Remedies for COVID-19
November 2020
Early during the coronavirus pandemic, hydroxychloroquine and chloroquine were considered potentially useful treatments for COVID-19. In this article, we discuss results of randomized clinical trials showing that hydroxychloroquine is not effective for treating or preventing COVID-19.
Leading Generic Drug Manufacturer Indicted by Feds for Price Fixing
November 2020
In his editor’s column, Dr. Michael Carome discusses U.S. Department of Justice charges brought against generic drug maker Teva for engaging in illegal price-gouging schemes for multiple prescription drugs.
Nitrosamine Impurities in Medications
November 2020
Since 2018, the FDA has found that certain commonly used medications contained unacceptable levels of nitrosamine impurities (contaminants) that are considered probable human carcinogens. Learn about the risks of nitrosamines and specific drugs that have been found to be contaminated with these compounds.
New Research Finds Folic Acid and Zinc Supplementation in Men Not Effective for Treating Infertility
November 2020
Supplements for male fertility often contain folic acid and zinc, likely because both substances have been shown to play key roles in the formation and maintenance of normal healthy sperm. However, data from a recently published clinical trial funded by the National Institutes of Health showed supplementation with folic acid and zinc in men among couples undergoing infertility treatment does not increase the chances of achieving a successful pregnancy.
Highlights of the New Guidelines for Severe Allergic Reaction
November 2020
We review new guidelines for treating life-threatening allergic reactions (known as anaphylaxis) recently issued by the American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma and Immunology.
Question & Answer
November 2020
In this month’s Question & Answer feature, we respond to a reader’s question asking about our recommended alternatives to the opioid analgesic tramadol (CONZIP, ULTRACET, ULTRAM), which we have designated as Do Not Use.
Public Citizen Calls on FDA to Require Black-Box Warning for Newest Diabetes Drugs
October 2020
Learn why patients with type 1 diabetes should never use any of the type 2 diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, which are often referred to as “flozins” or “gliflozins.”
“Male-Enhancing” Dietary Supplements Were Tainted With Dangerous Drugs
October 2020
In his editor’s column, Dr. Michael Carome discusses a recent report published in Morbidity and Mortality Weekly Reports that hammers home the potentially life-threatening dangers of using these illegal dietary supplements.
Gabapentinoid Drug Use Is Exploding Despite Poor Safety and Efficacy Profiles
October 2020
Marked increases in the prescribing of the gabapentinoids gabapentin and pregabalin, particularly for uses not approved by the FDA (so-called off-label uses), indicate that these drugs are widely overprescribed and misused in the U.S. In this article, we review three recent studies that characterized the growth and extent of gabapentinoid overuse during the past two decades.
Adults Often Inadvertently Put Children at Risk of Oral Medication Poisoning, Study Finds
October 2020
Ingestion of prescription medications or over-the-counter products is a common cause of poisoning among children. A recently published study found that adults frequently are to blame for this avoidable problem.
Important Drug Interactions for the Stomach-Acid–Suppressing Drug Omeprazole
October 2020
Patients taking the commonly used stomach-acid–suppressing drug omeprazole should be aware that it has clinically important interactions with many other prescription medications.
News Brief: Shortages in Albuterol Asthma Inhalers During the COVID-19 Pandemic
October 2020
In this month’s news brief, we report on shortages of the inhaled asthma drug albuterol that have occurred because of the coronavirus pandemic.
Key Takeaways From the Updated CDC Report on Antibiotic Resistance
September 2020
An updated report from the Centers for Disease Control and Prevention underscores the continued threat of antibiotic resistance in the U.S. and highlights the emerging areas of concern and actions needed to combat this major public health problem.
Evidence Lacking to Support Use of Compounded Topical Pain Creams
September 2020
In recent years, there has been a surge in the use of compounded topical pain creams as an alternative to oral pain medications, such as non-steroidal anti-inflammatory drugs and opioids. However, a committee of experts convened by the National Academies of Sciences, Engineering, and Medicine recently concluded that there is a lack of evidence to support the safety and effectiveness of these compounded products.
Testosterone Therapy for Men: More Evidence of Blood Clot Risk
September 2020
In this article, we discuss the results of a recent large observational study that provide added support for the concern that testosterone therapy heightens the risk of dangerous blood clot formation.
Review of Phenytoin, a Best Pill for Seizures
September 2020
Medications are the mainstay of treatment for most patients with seizure disorders, and more than two dozen such drugs have been approved by the FDA. We review one of the oldest seizure drugs, phe¬nytoin (DILANTIN, PHENYTEK). Patients using the drug need to be aware of its many potentially serious adverse effects.
Driving Under the Influence Caused by Medications
September 2020
Although impaired driving usu¬ally is caused by alcohol or marijuana, many commonly used prescription and over-the-counter medications also can impair one’s ability to drive safely. Learn about several classes of medications that can cause this serious problem to protect yourself, your passengers and others who share the road with you.
Recent FDA Safety Warnings About Schizophrenia Drug Clozapine, Asthma/Allergy Drug Montelukast
August 2020
Learn about important new safety warnings issued by the FDA regarding the schizophrenia medica¬tion clozapine (CLOZARIL, VERSA¬CLOZ) and the asthma/allergy drug montelukast (SINGULAIR).
Beware of Companies Promoting Bogus COVID-19 Cures
August 2020
Soon after the novel coronavirus began infecting people in the U.S., unscrupulous companies rushed to sell products not approved by the FDA with fake claims that they could prevent, treat or cure coronavirus disease 2019 (COVID-19). Consumers need to be aware that such products are fraudulent, a waste of money and potentially harmful.
Important Drug Interactions for the Anticoagulant Warfarin
August 2020
Patients taking the commonly used blood thinner warfarin (COUMADIN, JANTOVEN) should be aware that it has clinically important interactions with numerous other prescription and over-the-counter medications, as well as some dietary supplements.
Vitamin D and Calcium Dietary Supplements: Do They Prevent Bone Fractures?
August 2020
In this article, we discuss whether vitamin D and calcium dietary supplements are useful for promoting bone health and preventing bone fractures.
Allergists’ Group Recommends Newer Antihistamines Over Older Antihistamines for Nasal Allergies and Hives
August 2020
Because of the better safety profile of newer second- and third-generation antihistamines, Public Citizen’s Health Research Group has previously recommended their use over older first-generation antihistamines for both allergic rhinitis and urticaria. A recent position statement by the Canadian Society of Allergy and Clinical Immunology that summarized the research evidence about these drugs reinforces our recommendation.
Important Drug Interactions for the Antibiotic Azithromycin
July 2020
Patients taking the commonly prescribed antibiotic azithromycin (ZITHROMAX) should be aware that it has clinically important dangerous interactions with many other prescription medications.
Chloroquine and Hydroxychloroquine: Dangerous Options for COVID-19
July 2020
In his editor’s column, Dr. Michael Carome explains why President Trump’s reckless promotion of chloroquine and hydroxychloroquine as “game-changing” treatments for COVID-19 was so dangerous.
Melatonin Dietary Supplements: Useful for Jet Lag, Not for Other Conditions
July 2020
We summarize the available evidence from well-designed clinical trials that support the use of the dietary supplement melatonin for treating jet lag, but not other conditions.
Strong Topical Steroids Often Sold Over the Counter Illegally in the U.S., Study Finds
July 2020
New research reveals that potent, prescription-strength topical steroids can be purchased over the counter readily in many U.S. cities. Learn how to protect yourself and your loved ones from these illegal and potentially harmful products.
Daily Low-Dose Aspirin Should Not Be Used to Prevent a First Heart Attack or Stroke
July 2020
If you do not have cardiovascular disease, you should not take aspirin to prevent a first heart attack, stroke or other cardiovascular event, particularly if you are over the age of 60, because the benefits of such treatment generally do not exceed its bleeding risk.
Question & Answer
July 2020
In this month’s Question & Answer, we provide a list of websites that describe the appearance of prescription pills, resources that can help consumers protect themselves from life-threatening pharmacist errors.
Overview of the Insomnia Drug Zolpidem (AMBIEN, AMBIEN CR, EDLUAR, ZOLPIMIST)
June 2020
The insomnia drug zolpidem belongs to a family of drugs known as the non-benzodiazepines or “Z drugs.” Learn why we for years have designated this drug as Do Not Use.
Gilead Exploited FDA Loophole, Sought Windfall Profits From Pandemic
June 2020
Learn about Gilead Sciences’ greedy attempt to profiteer off of the catastrophic coronavirus (COVID-19) pandemic by seek¬ing and receiving a lucrative orphan drug designation from the FDA for an experimental drug being tested as a treatment for COVID-19.
Important Drug Interactions for Cholesterol-Lowering Drug Simvastatin
June 2020
Patients taking the commonly prescribed cholesterol-lowering drug simvastatin (FLOLIPID, VYTORIN, ZOCOR) should be aware that it has clinically important interactions with many other prescription medications.
Restless Legs Syndrome: Overdiagnosed and Overtreated
June 2020
In this review of restless legs syndrome (RLS), we discuss the limitations of the available drug treatments for the disorder and the nondrug approaches that are the safest options for people with mild to moderate RLS symptoms.
FDA Warns 15 Companies Selling “Snake Oil” Cannabidiol Products
June 2020
Except for one purified cannabidiol product approved by the FDA for treatment of two rare forms of childhood epilepsy, cannabidiol products marketed in the U.S. are illegal. Find out why the FDA is cracking down on companies selling these illegal drugs.
Drug-Induced Liver Injury
May 2020
There are more than 1,000 prescription and over-the-counter medications, as well as certain herbal and dietary supplements, that are implicated in liver injury, and the list continues to grow.
FDA Must Be Fully Transparent During the Novel Coronavirus Pandemic
May 2020
In his editor’s column, Dr. Michael Carome calls for greater FDA transparency regarding which drugs are in short supply because of the coronavirus pandemic and the resulting manufacturing disruptions in China and elsewhere.
For COPD Patients Without Heart Disease, Risks of Beta Blockers Outweigh Benefits
May 2020
Learn why you should avoid taking metoprolol or any other beta blocker if you have COPD and have not previously suffered a heart attack and do not have heart failure.
Norelgestromin-Ethinyl Estradiol Patch (XULANE): An Unsafe Choice for Birth Control
May 2020
We explain why the norelgestromin-ethinyl estradiol patch is too dangerous to use and describe safer birth control medication options.
Thiazides (Water Pills): Best Initial Treatment for High Blood Pressure, Study Finds
May 2020
We summarize results of new research showing that thiazides or thiazide-like diuretics, such as hydrochlorothiazide (MICROZIDE), appear to be the most effective and safest medications for initial treatment of hypertension.
News Brief: FDA Requests Withdrawal of Lorcaserin (BELVIQ), a Diet Drug That It Never Should Have Approved!
May 2020
In this month’s news brief, we discuss why the FDA decided to ask the manufacturer of the weight-loss drug lorcaserin to voluntarily withdraw the medication from the U.S. market.
Beware of Piracetam-Containing Dietary Supplements Touting Unproven Brain Benefits
April 2020
In this article, we explain why consumers need to beware of dietary supplements containing the illegal drug piracetam that are promoted to enhance cognitive performance, mood, sleep and longevity.
Protecting Yourself from Life-Threatening Pharmacist Errors
April 2020
In his editor’s column, Dr. Michael Carome discusses findings of a recent exposé published in The New York Times that highlighted how overworked pharmacists at major national pharmacy chains — such as CVS, Rite Aid and Walgreens — have endangered patients by making potentially fatal errors when filling and dispensing prescriptions.
Important Drug Interactions for the Antibiotic Clarithromycin
April 2020
Patients taking the commonly prescribed antibiotic clarithromycin (BIAXIN XL) should be aware that it has clinically important interactions with many other prescription medications.
Avoid the ‘Pink Pill’ Flibanserin (ADDYI) for Low Female Sexual Desire
April 2020
Learn why flibanserin is the wrong choice for women who are burdened by persistent low sexual desire.
FDA Warns of Serious Breathing Problems with Use of Gabapentin and Pregabalin
April 2020
For patients taking opioid analgesics and other drugs that depress breathing and those with lung diseases such as chronic obstructive pulmonary disease, use of gabapentin (GRALISE, HORIZANT, NEURONTIN) or pregabalin (LYRICA) could have deadly consequences.
Important Drug Interactions for the Calcium Channel Blocker Verapamil
March 2020
Patients taking the widely prescribed calcium channel blocker verapamil — which is used to treat high blood pressure, coronary artery disease and certain abnormal heart rhythms — should be aware that it has clinically important interactions with many other prescription medications.
Court Documents Expose Purdue’s Plans to Mislead Doctors About Oxycontin’s Risks
March 2020
Recently released court documents reveal the great lengths to which senior executives at Purdue Pharma — including members of the billionaire Sackler family who founded and own the company — went to downplay Oxycontin’s risks of addiction and abuse.
Study Bolsters Evidence Linking Menopausal Hormone Therapy to Breast Cancer
March 2020
New research linking menopausal hormone use to an increased risk of breast cancer reaffirms the importance of using such hormone therapies at the lowest effective dose and for the shortest duration needed.
Do Not Use Paroxetine (BRISDELLE) for Treatment of Hot Flashes
March 2020
Learn why women should avoid using BRISDELLE, the first and only nonhormonal drug approved by the FDA for treatment of hot flashes associated with menopause.
Public Citizen Urges FDA to Ban Medication Used to Prevent Preterm Birth
March 2020
We discuss why pregnant women who have a history of spontaneous preterm birth should not take the injected synthetic hormone hydroxyprogesterone caproate (MAKENA) to prevent another preterm birth.
Commonly Used Oral Drugs That Can Cause Eye Problems; Second of a Two-Part Series
February 2020
In this second of a two-part series, we review some of the many commonly prescribed medications that can damage your eyes and the steps that you can take to protect yourself from these adverse effects. The first part in this series appeared in our December 2019 issue.
Dollar Tree’s Over-the-Counter Drugs: Cheap, But Potentially Dangerous
February 2020
A recent warning publicized by the FDA suggests that although purchasing medications from Dollar Tree may appear to be good for your pocketbook, doing so may be dangerous to your health.
Available Evidence Shows Selenium Supplements Not Useful for Preventing Cancer But May Cause Harm
February 2020
Dietary supplements containing the trace mineral selenium for many years have been widely touted for the prevention of cancer. But the available scientific evidence shows that selenium is not useful for preventing cancer.
The Heart Rhythm Drug Amiodarone and Its Adverse Effects
February 2020
Public Citizen’s Health Research Group has designated amiodarone as Limited Use because long-term use of this drug can cause many types of adverse effects that can range from mild to life threatening. The drug should be used only when other therapies are ineffective or cannot be tolerated.
FDA Reapproves Primatene Mist Inhaler for Asthma Despite Concerns
February 2020
Learn why Primatene Mist, an over-the-counter form of the bronchodilator drug epinephrine, is a poor choice for treating asthma.
News Brief: Public Citizen Seeks Tighter Restrictions on Opioid Tramadol
February 2020
In this month’s news brief, we discuss Public Citizen’s recent petition to the FDA to move the opioid tramadol to a more restrictive classification of controlled substances because it is overprescribed, often misused, highly addictive and potentially deadly.
Updated Review of the Hair Loss and Prostate Drug Finasteride (PROPECIA, PROSCAR)
January 2020
For many years, we have classified both finasteride products as Do Not Use. Read our updated review to find out why.
Despite Rising Overdose Deaths, DEA Allowed More Opioids to Flood the U.S.
January 2020
In his editor’s column, Dr. Michael Carome discusses a government watchdog’s finding that the Drug Enforcement Administration allowed drug manufacturers to produce substantially larger quantities of opioids from 2002 to 2013, thus helping to fuel the opioid overdose epidemic.
New Study Makes Case for Increased Access to the Opioid Overdose Antidote Naloxone
January 2020
Learn about the results of new research suggesting that implementation of laws expanding naloxone access by authorizing pharmacists to dispense the drug without a prescription may result in fewer opioid-related deaths.
Important Drug Interactions for Immune-Suppressing and Cancer Drug Methotrexate
January 2020
Patients taking the commonly prescribed drug methotrexate, which is used to treat certain autoimmune diseases and several types of cancer, should be aware that it has clinically important interactions with many other prescription and over-the-counter medications.
Review of the Cough Medications Dextromethorphan and Benzonatate
January 2020
Despite its importance in maintaining clear airways and lung health, cough is one of the most common symptoms for which patients seek medical attention and is responsible for millions of doctor visits in the U.S. every year. Learn why the cough medications dextromethorphan and benzonatate generally should be avoided, particularly in children.
News Brief: FDA Cautions the Maker of Diet Drug QSYMIA for Misleading Advertising
January 2020
In this month’s news brief, we highlight a recent letter that the FDA issued to drugmaker Vivus that cited the company for making false or misleading claims on a promotional consumer-directed webpage for its oral weight-loss prescription drug QSYMIA, which we have designated as Do Not Use.
Commonly Used Oral Drugs That Can Cause Eye Problems; First of a Two-Part Series
December 2019
In this first of a two-part series, we review some of the many commonly prescribed medications that can damage your eyes and the steps that you can take to protect yourself from these adverse effects. The second part in this series will appear in our February 2020 issue.
Reckless Failure to Identify Dangerous Adverse Effect of New Diabetes Drugs
December 2019
In his editor’s column, Dr. Michael Carome discusses the failure of drug companies, researchers and the FDA to recognize the overwhelming evidence dating back to the early 1900s demonstrating that the new diabetes drugs known as “flozins” can cause life-threatening ketoacidosis.
Important Drug Interactions for the Antifungal Drug Fluconazole
December 2019
Patients taking the commonly prescribed antifungal drug fluconazole (DIFLUCAN) should be aware that it has clinically important interactions with many other prescription medications. Some of these interactions can lead to an increased risk of fatal heart rhythm abnormalities.
New Research Shows Vitamin D Supplements Not Useful for Preventing Cancer, Cardiovascular Disease or Diabetes
December 2019
Learn about results of two large, well-designed, randomized clinical trials funded by the National Institutes of Health demonstrating that high-dose vitamin D supplementation was not useful for preventing cancer, cardiovascular disease or diabetes.
New Study Finds Higher Risk of Psychosis with Amphetamine Treatment for ADHD
December 2019
Read this article to find out which drug treatment for attention deficit hyperactivity disorder has a greater risk of psychosis in adolescents and young adults.
Question & Answer
December 2019
Read our response to a reader who asked whether the drug pantoprazole (PROTONIX), which suppresses stomach acid, could have caused a false-positive urine screening test result for tetrahydrocannabinol (THC) — the chemical responsible for most of marijuana’s psychological effects.
Review of the Diet Drug Orlistat
November 2019
Learn about the many dangers that make the diet drug orlistat the wrong choice for patients who are trying to lose weight.
Big Pharma Sinks to Bottom of Barrel in Public Opinion Poll
November 2019
In his editor’s column, Dr. Michael Carome reviews the results of a recent Gallup poll showing that Americans now view the pharmaceutical industry more negatively than any other major industry in the U.S.
Medications That Cause Hearing Problems
November 2019
For most people with hearing loss, the condition likely is age-related or due to long-term exposure to loud noise. But for some patients, the cause of the problem can be found in the medicine cabinet.
Most Preventive Antibiotics Before Dental Procedures Are Unnecessary, Study Finds
November 2019
Dentists often prescribe antibiotics before dental procedures as prophylaxis to prevent infection from the release of bacteria from the mouth into the bloodstream. Find out which patients should receive such preventive antibiotics before dental procedures.
New Guideline Recommends Against Thyroid Hormone Treatment for Most Adults With Mildly Underactive Thyroid
November 2019
In this article, we describe a common condition known as subclinical hypothyroidism and discuss the newest guidelines regarding which patients with this condition should be treated with thyroid hormone replacement.
News Brief: FDA Announces Discovery of Cancer-Causing Contaminant in Heartburn Medication
November 2019
In this month’s news brief, we report actions taken by the FDA and regulators in other countries in response to the discovery of a probable human carcinogen in a widely used medication that suppresses stomach acid.
How to Dispose of Unused Opioids and Other High-Risk Drugs Safely
October 2019
Unused, unneeded or expired drugs in homes present a number of risks, including intentional or accidental overdose in humans (particularly young children). Learn how to safely dispose of these drugs.
Revolving Door to FDA Commissioner’s Office Sows Distrust in Agency
October 2019
In his editor’s column, Dr. Michael Carome discusses how FDA Commissioner Scott Gottlieb’s resumption of close ties to the pharmaceutical industry following his resignation from the agency created a cloud of justifiable distrust about actions taken by the FDA under his leadership.
An Update on Drug-Induced Parkinsonism
October 2019
Next to Parkinson’s disease, drug-induced parkinsonism is the second most common cause of parkinsonism, accounting for about 8-12% of all parkinsonism cases. Find out which commonly used drugs can cause this condition.
Recent FDA Safety Warnings About Drugs for Insomnia, Dietary Supplements
October 2019
The FDA recently issued two important safety alerts for doctors and patients. The first alert described risks of serious, often fatal injuries linked to use of the three so-called “Z-drugs” for insomnia. The second warned women of childbearing age not to use vinpocetine, an ingredient found in many widely available dietary supplements.
Foreign Regulators Issue Warnings About Wakefulness Drugs Modafinil (PROVIGIL) and Armodafinil (NUVIGIL)
October 2019
This article discusses important warnings issued by drug regulators in Canada and Ireland about new evidence of an increased risk of congenital birth defects associated with use of the stimulant drugs modafinil and armodafinil.
News Brief: Federal Researchers Link Kratom to 91 Unintentional Overdose Deaths
October 2019
In this month’s news brief, we report new data from the Centers for Disease Control and Prevention regarding the public health risks posed by kratom and kratom-containing dietary supplements, which have been falsely touted by some marketers as safe treatments for a variety of conditions, including anxiety, depression, opioid use disorder and pain.
Antibiotics Not Always Necessary for Acute COPD Exacerbations
September 2019
Doctors often prescribe antibiotics to treat acute exacerbations of chronic obstructive pulmonary disease (COPD), which are characterized by increased shortness of breath, cough, sputum production and wheezing. But for some patients, the risks of such antibiotic treatment outweigh the benefits.
FDA Sued for Dangerous Delay on Petition Seeking Stronger Drug Warnings
September 2019
In his editor’s column, Dr. Michael Carome discusses Public Citizen’s most recent legal maneuver to force the FDA to respond to our June 2016 petition seeking stronger warnings about the risk of compulsive or uncontrollable behaviors in the product labeling for a class of drugs known as dopamine agonists.
Oral Itraconazole and Terbinafine: Too Dangerous for Fungal Nail Infections
September 2019
Fungal infections of the toenails and fingernails, a condition known as onychomycosis, are common. Learn why you should never take oral itraconazole or terbinafine to treat these cosmetic, non-health-threatening nail infections.
Important Drug Interactions for the Seizure Drug Phenytoin
September 2019
Patients taking the commonly prescribed epilepsy drug phenytoin (DILANTIN, PHENYTEK), one of the oldest epilepsy drugs, should be aware that it has clinically impor¬tant interactions with many other prescription and over-the-counter medications. Some of these interactions can lead to phenytoin toxicity, and others can lead to ineffective seizure control.
An Updated Look at the Treatments for Rosacea
September 2019
Rosacea is a chronic skin condition affecting 13 million Americans. Find out steps to take to prevent symptom flare-ups and learn which topical drug therapies are most effective and safest for treating this condition.
Numerous Drugs Have Dangerous Interactions with Alcohol
August 2019
Most U.S. adults drink alcohol at least occasionally. Many also take prescription or over-the-counter drugs that have the potential to inter¬act adversely with alcohol. Avoid serious harm by knowing which drugs should not be taken in combination with alcohol.
44 States Sue Generic Drugmakers for Price-Fixing Scheme
August 2019
Allegations made in a recent lawsuit filed in federal court by 44 states suggest that 20 generic drug companies perpetrated a multi-billion-dollar fraud on the American public over the past decade.
Do Not Take Central Nervous System Stimulants for Weight Loss!
August 2019
Learn why Public Citizen’s Health Research Group advises against using any central nervous system stimulant drugs for weight loss.
Use of Tramadol for Arthritis Linked to Increased Risk of Death
August 2019
The FDA has approved five medications for treatment of cold sores — sometimes referred to as fever blisters, oral herpes or herpes labialis. Find out which of these drugs offer the most benefit.
Treatments for Cold Sores: An Updated Review
August 2019
Accounting for approximately 41 million prescriptions dis¬pensed in the U.S. in 2017, the opioid analgesic tramadol is among the most widely used painkillers. New research linking tramadol to an increased risk of death reinforces our long-standing Do Not Use designation for this drug.
Review of the Popular Stomach-Acid Suppressant Proton Pump Inhibitor Drugs
July 2019
Learn why the widely used proton pump inhibitors should be reserved for certain patients with stomach-acid disorders and only taken at the lowest possible dose for the shortest possible duration needed.
Rare Justice for Pharma Execs Who Illegally Marketed Dangerous Opioid
July 2019
Too often, senior executives of leading pharmaceutical companies that engage in illegal marketing of drugs and other serious crimes escape criminal prosecution. But this was not the case for the billionaire founder of Insys Therapeutics.
Fluoroquinolone Antibiotics Can Increase the Risk of Aortic Rupture, FDA Warns
July 2019
Read about the growing body of evidence showing that the commonly prescribed fluoroquinolone antibiotics increase the risk of potentially fatal ruptures or tears of the aorta, the largest blood vessel in the body.
Question & Answer
July 2019
A reader asked whether the FDA reviews and approves homeopathic drugs. Our answer should make you think twice about using these products.
Potentially Dangerous Interactions Between Erectile Dysfunction Drugs and Other Medications
July 2019
Find out about the many prescription medications that can interact in dangerous ways with the four drugs approved by the FDA for treating erectile dysfunction in men.
Patients Infrequently Screened Before Immunosuppressive Specialty Drug Therapy, Study Finds
July 2019
More and more patients are being treated with an expanding array of potent immunosuppressive drugs that require special screening and monitoring to minimize the risk of serious harm. But new research reveals that too many patients receiving these drugs are not undergoing the appropriate screening and monitoring tests.
For Some Drugs, Crushing Tablets or Opening Capsules Can Yield Fatal Consequences
June 2019
Patients who have difficulty swallowing pills will sometimes crush tablets or open capsules and sprinkle the resulting powder, fragments or granules into food or liquids. Other patients will resort to chewing their pills before swallowing. Find out the dangers posed by taking such measures.
Time to End Tax Breaks for Direct-to-Consumer Prescription Drug Ads
June 2019
In his editor’s column, Dr. Michael Carome advocates federal legislation that would abolish the harmful tax breaks given to Big Pharma for the costs of direct-to-consumer prescription drug advertising.
Review of the Asthma Drugs Montelukast (SINGULAIR) and Zafirlukast (ACCOLATE)
June 2019
Learn why Public Citizen’s Health Research Group has designated the asthma drugs montelukast and zafirlukast as Do Not Use.
Taking These Medications With Grapefruit Can Be Dangerous!
June 2019
Read about the many prescription drugs that can interact in dangerous ways with grapefruit or grapefruit products.
FDA Warns of Life-Threatening Blood Clots with Use of High-Dose Tofacitinib
June 2019
In this article, we discuss preliminary data from an ongoing clinical trial that prompted the FDA to issue a new warning about potentially fatal blood clots caused by tofacitinib, an oral drug used to treat rheumatoid arthritis and other inflammatory diseases.
Review of Testosterone Products
May 2019
Approximately 10 years ago, testosterone makers launched a massive direct-to-consumer advertising campaign to promote the use of testosterone for normal age-related declines in testosterone in men. Learn why such use of testosterone can be dangerous without providing any proven benefit.
Beware of Companies Hawking Snake Oil for Alzheimer’s Disease
May 2019
The FDA’s recent warning about a dozen companies that marketed illegal products purported to treat or prevent Alzheimer’s disease highlights the importance of ignoring advertisements promoting miracle cures for serious diseases.
Indacaterol (ARCAPTA NEOHALER): The Wrong Choice for COPD
May 2019
In this article, we explain why the FDA should not have approved indacaterol, a long-acting inhaled bronchodilator, for long-term treatment of COPD without first requiring further clinical trials testing lower doses of the drug than the currently approved dose.
Colchicine Interactions with Other Drugs Can Be Life-Threatening
May 2019
Read about the many prescription medications that can interact in dangerous ways with colchicine, a commonly used drug for treatment of acute gout attacks.
Medications That Induce Breast Enlargement in Men
May 2019
For men, abnormally large breasts can be distressing and embarrassing. Find out about the numerous drugs that can cause breast enlargement in men.
Review of the Osteoporosis Drug Denosumab (PROLIA)
April 2019
Learn why we have designated Prolia as Do Not Use for treatment of osteoporosis in women and men.
Pharma's Price Gouging on Insulin Is Literally Killing Patients
April 2019
Many diabetes patients, including some with health insurance, can no longer afford to take the dosage of life-saving insulin prescribed by their doctors because of price gouging by the pharmaceutical industry. For some of these patients, the rationing of unaffordable insulin has proved to be fatal.
Medications that Cause Taste Disorders
April 2019
Drugs are the most frequent cause of taste disturbances. In this article, we identify more than 60 commonly used prescription medications that have been linked to problems with taste.
Suicidal Thoughts: Latest Risk for Baldness and Prostate Drug Finasteride (PROPECIA, PROSCAR)
April 2019
In this article, we discuss a new reason for why finasteride should not be used by men to treat symptoms of prostate enlargement or male pattern baldness.
New Research Finds Increased Water Intake Helps Prevent Recurrent Bladder Infections, Reduces Use of Antibiotics in Premenopausal Women
April 2019
Many women are plagued by frequent bladder infections, and use of antibiotics to treat bladder infections comprises a major proportion of antibiotic use around the globe. Read about new research showing that increased water intake in women markedly reduces the frequency of bladder infections and the need for antibiotics.
News Brief: Dangerous Gout Medication Withdrawn from Market
April 2019
In this month’s news brief, we report on Ironwood Pharmaceuticals’ recent decision to cease marketing its dangerous gout drug lesinurad (ZURAMPIC, DUZALLO). Several years ago, we had designated the drug as Do Not Use because its substantial risks far outweighed its benefits.
Study Reveals Increased Risk of Bleeding, Stroke from Combined Use of Oral Blood Thinners and NSAIDs
March 2019
Millions of Americans take anticoagulants on a long-term basis to prevent the formation of potentially harmful clots. Learn why such patients should avoid using nonsteroidal anti-inflammatory drugs.
Caving To Industry, FDA Kills Proposed Safety Rule on Generic Drug Labeling
March 2019
In his editor’s column, Dr. Michael Carome laments the FDA’s troubling decision to withdraw a proposed rule that would have allowed generic drug companies to promptly update safety warnings in their product labels.
Potentially Dangerous Lithium Drug Interactions
March 2019
Read about the many prescription medications that can interact in dangerous ways with lithium, the drug of choice for treating bipolar disorder, also known as manic depression.
Drug-Induced Restless Legs Syndrome
March 2019
Restless legs syndrome is a common neurological movement and sensory disorder that affects 5 to 10 percent of the population. In this article, we identify some of the many drugs that can cause or worsen this disorder.
Review of the Synthetic Human Growth Hormone Drug Somatropin
March 2019
Somatropin was first approved by the FDA in 1987 for the treatment of short stature in children with growth hormone (GH) deficiency. Find out why we recommend not using somatropin in children with short stature who have normal GH levels; people who develop GH deficiency in adulthood; or in healthy individuals as an anti-aging agent, to improve athletic performance or for body-building.
New Research Shows Aspirin Is Not Beneficial for Older Adults Without Cardiovascular Disease
February 2019
Aspirin is widely used to prevent heart attacks and strokes in the elderly. Read this article to learn whether such use of aspirin is the right choice for you.
In Face of Raging Opioid Addiction Crisis, FDA Fuels the Fire
February 2019
In his editor’s column, Dr. Michael Carome slams the FDA for its reckless approval of a dangerous new opioid that will be marketed under the brand name Dsuvia.
New Study Finds Frequent Unsafe Use of the Sleep Aid Zolpidem
February 2019
For many years, we have designated the prescription sleep medication zolpidem as Do Not Use. We review the results of new research exposing the frequent misuse of this dangerous medication.
News Brief: FDA Bans Imports of All Drugs from Chinese Drug Manufacturer That Produced Tainted Valsartan
February 2019
In this month’s news brief, we report on actions taken by the FDA to stop the flow of tainted medications made by a Chinese drug manufacturer into the U.S.
Systemic Corticosteroids Ineffective for Low Back Pain
February 2019
Low back pain is a frequent reason for outpatient and emergency room visits among adults. Read why treatment with corticosteroids is a poor choice for treating this common condition.
New Study Supports Link Between Oral Pain Reliever Diclofenac and Cardiovascular Risks
February 2019
This article discusses new research linking use of oral diclofenac, a nonsteroidal anti-inflammatory drug, to an increased risk of heart attacks, strokes and other adverse cardiovascular events.
Important Clopidogrel (PLAVIX) Drug Interactions
January 2019
Read about the many prescription and over-the-counter medications that can interact in dangerous ways with clopidogrel, a widely used anti-platelet drug.
Florida Clinic Brazenly Deceives Patients About a Cancer “Treatment”
January 2019
In his editor’s column, Dr. Michael Carome recounts how a Florida medical clinic deceived patients by falsifying scientific journal citations in its promotion of a now-illegal heart-toxic drug called cesium chloride for treatment of cancer.
FDA Warns About Serious Genital Infections With Newest Class of Diabetes Drugs
January 2019
Learn about a rare but potentially fatal bacterial infection in the area of the genitals that has been linked to the diabetes drugs known as sodium-glucose cotransporter-2 inhibitors, commonly called “flozins.”
New Study Links Statins to a Rare Autoimmune Muscle Disorder
January 2019
In this article, we review new research showing that statins are associated with a potentially disabling autoimmune muscle disorder known as idiopathic inflammatory myositis, a rare disorder that is distinct from the much more common type of muscle injury seen with statins.
Review of the Parkinson’s Disease Drug Apomorphine (APOKYN)
January 2019
Find out about the risks and benefits of apomorphine, an injectable medicine approved by the FDA for treatment of specific symptoms that occur in patients with advanced Parkinson’s disease.
Question & Answer
January 2019
In response to a reader’s question about our article “Metformin: First-Choice Drug for Type 2 Diabetes” in the August 2018 issue, we discuss the risk of diarrhea and other adverse gastrointestinal effects that may occur when taking metformin.
Public Citizen Seeks Ban of Dangerous Cesium Dietary Supplements
December 2018
Dietary supplements containing cesium chloride or other types of cesium salts are among the most hazardous supplements currently marketed in the U.S. Read this article to find out why.
Our Assessments of Medications Sometimes Change Over Time
December 2018
In his editor’s column, Dr. Michael Carome, prompted by a recent letter from one of our readers, discusses why our recommendations and designations for specific drugs sometimes change based on new information.
Baricitinib (OLUMIANT): The Wrong Choice for Rheumatoid Arthritis
December 2018
Baricitinib is the most recent drug approved by the FDA for treatment of patients with rheumatoid arthritis. Read our assessment of this dangerous drug.
Study Suggests Frequent Improper Use of Systemic Corticosteroids for Respiratory Illnesses
December 2018
In this article we discuss new research showing that patients with acute respiratory illnesses too often are treated inappropriately with corticosteroid drugs, exposing them to unnecessary risks.
Patient-Initiated Deprescribing of Benzodiazepines
December 2018
Learn how patients can initiate a discussion with their doctors to begin the process of weaning off benzodiazepines, a class of highly overprescribed sedative hypnotic drugs primarily used to treat anxiety and insomnia.
Potentially Dangerous Digoxin Drug Interactions
November 2018
Read about the numerous medications that can interact with digoxin, a drug commonly prescribed for heart failure and atrial fibrillation. These interactions can result in either digoxin toxicity or decreased digoxin effectiveness depending on the other drug being used concomitantly.
Hospitals Band Together to Bypass Big Pharma, Start Their Own Drug Company
November 2018
In his editor’s column, Dr. Michael Carome discusses the implications of a major initiative by a large group of U.S. hospitals to establish their own not-for-profit generic pharmaceutical company.
Review of Varenicline (CHANTIX) for Smoking Cessation
November 2018
If you are a smoker, quitting is the most important thing you can do for your health. Learn why we recommend that varenicline only be used a last-resort drug for smoking cessation.
New USPSTF Recommendations Address How Older Adults Can Prevent Falls and Fractures
November 2018
This article reviews the recent recommendation issued by the U.S. Preventive Services Task Force (USPSTF), an independent volunteer panel of national experts in disease prevention, against older adults taking extra vitamin D to prevent falls.
Valproic Acid and Divalproex: High Risk of Birth Defects
November 2018
Find out why women of child-bearing age should avoid taking valproate for migraines and should use it only for seizure or bipolar disorder if other medicines fail to adequately control these conditions or cause unacceptable adverse effects.
News Brief: FDA Responds to Public Citizen Petition to Block Use of Dangerous Cancer Treatment
November 2018
In this month’s news brief, we report on the Food and Drug Administration’s recent action regarding our petition to prohibit the use of heart-toxic cesium chloride — which has been promoted as an alternative treatment for cancer — in pharmacy compounding.
False-Hope Alzheimer’s Disease Drugs
October 2018
The FDA has approved four drugs for treating Alzheimer’s disease, a devastating brain disorder that affects nearly 6 million Americans, most of whom are elderly. Learn why we have designated each of these drugs as Do Not Use.
New Research Shows Drugs Associated with a Risk of Depression Are Widely Used
October 2018
In this article, we summarize the results of a recent research study showing that use of medications that have depression as a potential adverse effect is very common. We also identify some of the many prescription medications that can cause depression symptoms, including suicidal thoughts or behavior.
Review of Lamotrigine (LAMICTAL)
October 2018
For certain types of epilepsy, lamotrigine is an appropriate treatment for preventing seizures. Learn about the common and serious adverse effects that can occur while taking this drug and how to take this drug safely.
FDA Announces Recalls of Certain Valsartan-Containing Medications Because of Cancer-Causing Contaminant
October 2018
We have received numerous questions from readers asking what to do about the recent recalls of valsartan-containing drugs sold by certain companies that were found to be tainted with a probable carcinogen. In this article, we offer advice for those patients who have been taking valsartan.
Question & Answer
October 2018
Several readers have asked us whether the FDA’s recent approval of a drug that reverses the anticoagulant effect of apixaban (ELIQUIS) and rivaroxaban (XARELTO) alters our classification of these two drugs as Do Not Use. Read our answer.
HHS Inspector General Documents Big Pharma’s Price Gouging of Seniors
October 2018
In his editor’s column, Dr. Michael Carome discusses the implications of a recent government report which found that annual out-of-pocket expenses for brand-name drugs covered under Medicare Part D have skyrocketed in recent years.
Aripiprazole (ABILIFY) Drug Interactions
September 2018
Read about the more than two dozen medications that can have clinically important interactions with aripiprazole, one of the widely used newer atypical antipsychotic drugs that is approved by the FDA for treatment of several disorders including schizophrenia, bipolar disorder and depression.
New Study Links Fluoroquinolones to Life-Threatening Blood Vessel Complication
September 2018
In this article, we discuss results of new research linking the widely overused fluoroquinolone antibiotics to an increased risk of life-threatening damage to the body’s largest blood vessel, the aorta.
Review of Medroxyprogesterone (DEPO-PROVERA, DEPO-SUBQ PROVERA 104, PROVERA)
September 2018
Hear our recommendations on the use of medroxyprogesterone, a prescription medication containing a synthetic form of the female hormone progesterone that is most commonly used for contraception and hormone therapy in women.
Prompted by Public Citizen Lawsuit, FDA Finally Acts to Protect Infants from Dangerous Benzocaine Teething Gels
September 2018
Learn why benzocaine-containing gels and liquids should never be used to treat teething discomfort and about Public Citizen’s Health Research Group’s successful campaign to force the FDA to pull these products from the market.
Agency Insiders Recount FDA’s Cozy Relationship with Industry
September 2018
In his editor’s column, Dr. Michael Carome reviews the relationship between the development of a deeply entrenched industry-friendly culture within the FDA and the agency’s increasingly lax oversight of prescription drugs.
Metformin: First-Choice Drug for Type 2 Diabetes
August 2018
Learn why metformin is the drug of choice for the initial treatment of patients with type 2 diabetes who are not able to control their blood sugar through diet and exercise alone and who do not have severe kidney impairment.
NIH-Funded Clinical Trial Finds Omega-3 Fatty Acid Supplements Not Helpful for Treating Dry Eyes
August 2018
Countless companies heavily promote dietary supplements containing omega-3 fatty acids as the solution to many health problems, including dry eyes. But results of a new research study funded by the National Institutes of Health demonstrate that omega-3 fatty acids are not a good choice for treating dry eyes.
FDA Warns Against Use of Opioid-Containing Cough and Cold Medications in Children
August 2018
In this article, we review the dangers of using opioid-containing cough and cold medicines in children younger than age 18.
Illegally Promoting a Dangerous Opioid With Sex, Guns and Cash
August 2018
In his editor’s column, Dr. Michael Carome discusses the outrageous tactics that sales representatives from drugmaker Insys Therapeutics allegedly used to illegally promote fentanyl sublingual spray (SUBSYS), a rapid-acting, highly addictive, dangerous opioid that is sprayed under the tongue.
Bupropion (ZYBAN) for Smoking Cessation
August 2018
If you are a smoker, quitting is the most important thing you can do for your health. Find out whether bupropion (ZYBAN) is an appropriate treatment option to increase your chances of successfully quitting.
Many People Overdose on Ibuprofen (ADVIL, IBU-TAB, MOTRIN) and Similar Drugs
July 2018
Overdosing on commonly used nonsteroidal anti-inflammatory drugs can increase your risk of potentially serious adverse effects, including gastrointestinal bleeding and kidney damage. Learn how to protect yourself from unintentional overdoses of these medications.
Making Opioid Overdose Antidote Affordable Would Save Lives
July 2018
In his editor’s column, Dr. Michael Carome discusses a rarely used authority of the federal government that would lower the price for the opioid-overdose antidote naloxone and save lives.
High-Dose Inhaled Corticosteroids for Asthma Exacerbations: Helpful in Adults and Adolescents, But Not in Children
July 2018
Inhaled corticosteroids are one of the mainstays of asthma treatment in adults and children, and increasing the dose of these medications when early signs of worsening asthma control occur is a commonly recommended strategy. Find out whether this treatment strategy is a safe and effective choice.
Drug-Induced Tremor
July 2018
Tremor is the single most common movement disorder, affecting millions of people in the U.S. If you have tremors, could one of your drugs be the cause? Read this article to learn the answer.
New Report on Big Pharma Settlements Highlights Need for Tougher Enforcement
July 2018
In this article, we present the findings of our most recent report cataloging all major financial settlements that the pharmaceutical industry has been forced to sign with federal and state governments since 1991. The report’s most striking finding is a recent precipitous drop in federal criminal penalties against drug companies.
News Brief: Multiple Sclerosis Drug Withdrawn Because of Serious Safety Concerns
July 2018
In this month’s news brief, we report on the Food and Drug Administration’s announcement that a medication for multiple sclerosis is being withdrawn from the market because of serious safety concerns.
Preventing Heat-Induced Death and Illness
June 2018
This article lists practical steps to take to avoid death, hospitalization or other medical problems caused by heat stress. It also identifies over 100 drugs that can impair your response to heat and thereby increase your risk of heat-induced illness and death.
FDA's "Breakthrough Therapies" Designation Often Misleading
June 2018
In his editor’s column, Dr. Michael Carome discusses an analysis by researchers at Harvard University that suggests that patients and doctors are being misled about the benefits of drugs approved under the FDA’s “breakthrough therapies” pathway.
Antibiotic Clarithromycin May Increase Risk of Death, FDA Warns
June 2018
Clarithromycin is an oral antibiotic that is commonly used to treat a wide range of bacterial infections. Learn why patients with heart disease should avoid this antibiotic unless no other suitable antibiotic is available.
Do Not Use the New Oral Blood Thinner Apixaban (ELIQUIS)
June 2018
Apixaban is a new oral anticoagulant (blood thinner) that was first approved by the FDA in 2012 for decreasing the risk of blood clots in certain patients. Find out why older anticoagulant drugs, such as warfarin (COUMADIN, JANTOVEN), are a better choice.
Topical Clobetasol Propionate: Only Use to Treat Severe Skin Disorders
June 2018
All but one of the clobetasol propionate products are classified as super-high potency topical corticosteroids. They are approximately 1,000 times more potent than over-the-counter 1-percent hydrocortisone. This article offers advice on how to use these products safely.
Overview of the Antiplatelet Drug Prasugrel (EFFIENT)
May 2018
Prasugrel is an oral antiplatelet drug that was approved by the FDA in 2009 as an add-on treatment to aspirin to prevent clots from forming that may cause a heart attack or stroke in certain patients with coronary artery disease. Learn why we recommend avoiding this medication.
TV Drug Ads Routinely Fail to Comply with FDA Requirements
May 2018
Pharmaceutical companies spend billions of dollars annually advertising their products directly to consumers on TV. But as Worst Pills, Best Pills News Editor Dr. Michael Carome explains, prescription drug TV ads often fail to fully adhere to FDA regulations governing direct-to-consumer ads.
News Brief for May 2018
May 2018
In this month’s News Brief, we report the sentencing of the former supervisory pharmacist at the now-shuttered New England Compounding Center located in Framingham, Massachusetts to eight years in prison for his role in the deadly nationwide fungal meningitis outbreak in 2012 that had been linked to tainted steroid drugs made by the company.
Gout Drug Febuxostat (ULORIC): Risks Outweigh Benefits
May 2018
When the FDA approved febuxostat in 2009 for treating high uric acid blood levels in patients with gout, we advised readers not to use the drug until at least February 2016 based on our longstanding “Seven-Year Rule.” Read this article to hear results of new research that prompted us to now designate febuxostat as Do Not Use.
USPSTF Recommends Against Hormone Therapy to Prevent Chronic Conditions in Postmenopausal Women
May 2018
This article reviews the recent recommendation issued by the U.S. Preventive Services Task Force, an independent volunteer panel of national experts in disease prevention, against the use of hormone replacement therapy in postmenopausal women in order to prevent chronic conditions such as heart disease, stroke, diabetes, dementia, cancer and osteoporosis.
Oral Baclofen Effective Only for Multiple Sclerosis
May 2018
Find out why the muscle relaxant baclofen is a reasonable choice for treating reversible muscle spasms in patients with multiple sclerosis but should not be used to treat spasticity due to spinal cord injuries or other spinal cord diseases.
Public Citizen Urges FDA to Improve Drug Ad Requirements
May 2018
In 2017, the FDA announced its intention to consider allowing drug companies to reduce the amount of risk information they disclose to consumers in direct-to-consumer prescription drug television or radio ads. This article discusses why the FDA’s proposal would be bad for consumers.
Beware of Companies Peddling Illegal Opioid Addiction Remedies
April 2018
In his editor’s column, Dr. Michael Carome offers advice on how to avoid being conned by unscrupulous companies promising miracle treatments for opioid addiction and withdrawal.
Topiramate: Limit Use to Treatment of Seizures, Do Not Use for Other Conditions
April 2018
Topiramate is a second-generation antiepileptic drug that was originally approved by the FDA in 1996. In this article, we discuss why topiramate is an appropriate option for treating certain seizure disorders but should not be used for treatment of migraine headaches.
Extended-Release Niacin (NIASPAN): Now Designated as Do Not Use
April 2018
Extended-release niacin is approved by the FDA to reduce elevated cholesterol levels and to reduce the risk of recurrent, nonfatal heart attacks in patients with histories of previous heart attacks and elevated cholesterol levels. Learn why we just changed the designation of niacin extended-release tablets from Limited Use to Do Not Use.
Nebivolol (BYSTOLIC): Limited Use for Hypertension
April 2018
When the beta blocker nebivolol was approved by the FDA in 2007, we advised readers not to use the drug until 2015, in accordance with our seven-year rule. Find out why we now have designated nebivolol as Limited Use and whether it is the right choice for treating hypertension.
FDA Issues a Public Health Advisory Regarding the Dangerous Plant Kratom
April 2018
Read this article to learn about recent FDA public health advisories warning against the use of kratom and kratom-containing dietary supplements, which have been falsely touted by some marketers as safe treatments that have broad healing properties.
10 Rules for Safer Drug Use
March 2018
Patients often wonder what steps they can take to minimize their chances of suffering a serious adverse drug reaction. This article reviews 10 simple rules developed by Public Citizen’s Health Research Group for ensuring safer drug use.
Big Pharma Rings in New Year with More Price Gouging
March 2018
In his editor’s column, Dr. Michael Carome highlights the most recent wave of price hikes by major pharmaceutical companies at the start of 2018.
Review of Gabapentin
March 2018
The FDA has approved gabapentin (NEURONTIN) for several conditions, including a type of seizure disorder, shingles pain and restless leg syndrome. Hear our recommendations for who should use gabapentin and who should avoid it.
FDA: Drug for Treating High Blood Potassium Levels Should Not Be Combined with Other Medications
March 2018
Last year, the FDA warned that a drug used to treat high blood potassium levels can interfere with the absorption of many other oral medications. Learn the name of this drug and how to take it safely when using other drugs.
Questions & Answers
March 2018
We respond to readers’ questions about our October 2017 article regarding the use of vitamin E for preventing or treating mild cognitive impairment or Alzheimer’s disease and our December 2017 article regarding the use of desmopressin spray (NOCTIVA) for treating nighttime urination symptoms.
Meclizine: A Risky and Possibly Ineffective Drug
March 2018
Meclizine is a drug that is commonly used to treat symptoms of motion sickness. Find out why we have designated this drug as Do Not Use.
Do Not Use Fentanyl for Non-Cancer Pain
February 2018
Fentanyl is a dangerous synthetic opioid that has been involved in an increasing number of overdose deaths in the U.S. Learn why this drug should be used only by cancer patients with breakthrough cancer-related pain.
FDA Dragging Its Feet on Improving Presentation of Risk Information in TV Drug Ads
February 2018
In 2007, Congress passed legislation aimed at improving the disclosure of risk information in TV ads for prescription drugs by mandating that ads present this information in a “clear, conspicuous, and neutral manner.” Worst Pills, Best Pills News Editor Dr. Michael Carome takes the FDA to task for never implementing the requirements of this 2007 law.
Incorrect Dosing of Obeticholic Acid (OCALIVA) Could Be Fatal, FDA Warns
February 2018
Obeticholic acid is a second-line treatment for patients with a rare liver disease called primary biliary cholangitis. In this article, we discuss how to appropriately dose the drug in order to avoid life-threatening liver damage.
Clozapine for Treatment-Resistant Schizophrenia: Use With Great Caution
February 2018
No other schizophrenia medicine is more dangerous than clozapine. Learn about the drug’s serious unique risks and why it should be used only by severely ill schizophrenia patients who have failed to respond adequately to other antipsychotic medications.
Drug-Induced Movement Disorders
February 2018
Abnormal involuntary movements (movement disorders) occur as adverse events associated with many widely used medications and can cause substantial hardship for affected individuals. Find out which drugs are associated with these adverse effects.
News Brief for February 2018
February 2018
In this month’s News Brief, we report on Public Citizen’s Health Research Group’s petition to the FDA to ban a cancer treatment ingredient from use in pharmacy compounding because of serious health risks to humans and no evidence of benefit.
Do Not Use Olmesartan for High Blood Pressure
January 2018
Olmesartan (BENICAR) is one of eight drugs in the family of commonly used blood pressure-lowering medications known as angiotensin II receptor blockers. Learn about the severe, life-threatening gastrointestinal adverse effects of olmesartan that could land you in the hospital.
Opioid Maker Executives “No Better Than Street-Level Drug Dealers”
January 2018
Worst Pills, Best Pills News Editor Dr. Michael Carome discusses the recent arrest of John Kapoor, the billionaire founder of Insys Therapeutics — the drug company that markets fentanyl sublingual spray (SUBSYS), a highly addictive, dangerous opioid drug. Kapoor has been charged with “leading a nationwide conspiracy” to profit by bribing doctors to inappropriately prescribe the company’s fentanyl spray product.
Study Links Sleeping Pills to Hip Fractures in the Elderly
January 2018
Every year, more than 300,000 older Americans are hospitalized due to hip fractures, and almost all of these fractures are caused by falls. Read about new research further linking use of sleeping pills to an increased risk of falls and serious injury.
Milnacipran For Fibromyalgia: Do Not Use
January 2018
Milnacipran (SAVELLA) was approved by the Food and Drug Administration in 2009 for the treatment of fibromyalgia in adults, which remains its only approved use. In this article, we review data showing that the drug is ineffective for treating fibromyalgia and dangerous.
Do Not Use Mirabegron (MYRBETRIQ) for Overactive Bladder
January 2018
Overactive bladder is a bothersome — but not serious — medical problem that becomes more common with age. Find out why mirabegron is the wrong choice for treating this condition.
The Dangerous Diabetes Drug Pramlintide: Do Not Use
December 2017
In this article, we explain why the serious adverse effects of the injected diabetes drug pramlintide far outweigh the drug’s limited benefits.
At the Behest of the Opioid Drug Industry, Congress Undermined the DEA
December 2017
Worst Pills, Best Pills News Editor Dr. Michael Carome discusses how the opioid drug industry successfully lobbied Congress to pass a dangerous bill that effectively stripped the Drug Enforcement Agency of one of its strongest enforcement tools for fighting the illegal diversion of opioid drugs.
Drugs That Cause Weight Gain
December 2017
Weight gain is an adverse event associated with many widely used medications and may lead to significant overweight and obesity, especially in susceptible individuals. Find out which drugs have this adverse effect.
Drug for Treating Nighttime Urination Too Dangerous
December 2017
Nighttime urination is a common symptom that becomes more common with increasing age. Learn why the only drug approved for treating this symptom offers only meager benefits along with unacceptable risks.
Rifaximin (XIFAXAN): Another Poor Choice for Treating Irritable Bowel Syndrome
December 2017
Rifaximin was approved by the FDA in May 2015 for treating irritable bowel syndrome with diarrhea as the predominant symptom in adults. Find out about the drug’s serious adverse effects that outweigh its limited benefits.
Do Not Use the New Blood Thinner Edoxaban (SAVAYSA)
November 2017
Learn why edoxaban, one of the new blood thinners approved by the FDA, is not the best option for preventing dangerous blood clots in patients with atrial fibrillation.
FDA Cracks Down on Illegal Stem Cell Treatments
November 2017
Over the past decade, the number of clinics in the U.S. that peddle unproven stem cell "treatments" directly to consumers exploded from a handful in 2010 to as many as 570 in 2016. Find out what the FDA is finally doing to clamp down on the marketing of illegal stem cell treatments.
Corticosteroid Injections Not Beneficial for Knee Osteoarthritis
November 2017
The injection of corticosteroids into the knee joints of patients with osteoarthritis of the knee is a widespread practice. Find out the results of new research funded by the National Institutes of Health showing that such injections actually may accelerate joint damage.
Subclinical Hypothyroidism: When to Treat
November 2017
In this article, we describe a common condition known as subclinical hypothyroidism and discuss which patients with this condition should be treated with thyroid hormone replacement.
News Brief for November 2017
November 2017
In this month’s news brief, we report the FDA’s reckless decision to deny Public Citizen’s petition to ban a dangerous anti-fungal drug.
Pregabalin (LYRICA): Neither Effective nor Safe for Treating Sciatica Leg Pain
November 2017
Doctors often prescribe pregabalin for a neuropathic pain condition known as sciatica, a use that is not approved by FDA. Find out why pregabalin is a bad choice for treating sciatica.
U.S. Senate Passes 'False-Hope' Act
October 2017
In August, the U.S. Senate unanimously passed the so-called Right to Try Act. Worst Pills, Best Pills News Editor Dr. Michael Carome explains how this deceptively named bill would put countless patients at risk by undermining important FDA safety rules related to the use of unapproved, experimental medications.
News Brief for October 2017
October 2017
In this month’s news brief, we report on the FDA’s recent decision to partially grant a petition from Public Citizen to require the addition of a warning about a dangerous drug-drug interaction to product labeling of repaglinide-containing diabetes medications.
Tofacitinib (XELJANZ): The Wrong Choice for Rheumatoid Arthritis
October 2017
Tofacitinib is one of the newer medications approved by the FDA for treatment of rheumatoid arthritis. Learn why we have designated this drug as Do Not Use.
Diabetes Drug Canagliflozin Doubles Risk of Amputations, FDA Warns
October 2017
Canagliflozin is one of three medications in the newest diabetes drug class. In this article, we discuss why the FDA recently required that a black-box warning about the risk of amputations be added to the product labeling of canagliflozin.
Vitamin E Does Not Prevent Declines in Memory and Cognitive Function
October 2017
Dietary supplement makers often tout vitamin E products for a variety of purported health benefits, including the promotion of brain health. Find out why vitamin E supplements are unlikely to prevent cognitive decline and may cause serious harm if taken in doses exceeding the recommended dietary allowance.
Injected Naltrexone for Opioid Addiction
October 2017
Hear how drugmaker Alkermes has engaged in a novel but troubling marketing campaign to increase sales of its once-monthly injected version of naltrexone (VIVITROL) for treatment of opioid addiction.
Owner of Drugmaker Linked to Meningitis Outbreak Convicted of Racketeering But Acquitted of Murder
September 2017
In March 2017, a federal jury found the co-owner of a now-bankrupt Massachusetts compounding pharmacy guilty on more than 50 counts of racketeering and mail fraud for his role in the deadly nationwide fungal meningitis outbreak in 2012, which had been linked to tainted steroid drugs. Read the troubling details of how the company’s co-owner escaped being convicted of second-degree murder.
A Dangerous Proposal to Roll Back Pharmacy Compounding Rules
September 2017
Following a deadly fungal meningitis outbreak linked to a Massachusetts compounding pharmacy’s tainted steroid drugs, Congress in 2013 passed a law to strengthen the FDA’s oversight of the compounding pharmacy industry. Learn about reckless legislation now being considered by Congress that would reverse the 2013 law.
New Evidence Refutes Testosterone Benefits for Age-Related Symptoms
September 2017
In this article, we discuss new data from well-designed randomized controlled trials that show that testosterone treatment in older men with low testosterone blood levels does not improve memory or other cognitive functions and actually increases the buildup of cholesterol in coronary arteries.
Naltrexone-Bupropion (CONTRAVE): Another Dangerous Weight-Loss Drug
September 2017
Learn why Public Citizen’s Health Research Group has designated CONTRAVE, a combination weight-loss medication that was approved by the FDA in 2014, as Do Not Use.
Black-Box Warning Added to Hepatitis C Drugs
September 2017
The FDA recently required that the product labeling for several of the newest hepatitis C drugs be revised to include a black-box warning, the strongest warning that the agency can require. Find out what the new warning says.
Abuse-deterrent Opioids
September 2017
To address the growing epidemic of prescription opioid drug overdoses in the U.S., many drugmakers have attempted to develop opioid pills that are supposedly resistant to being manipulated in ways that make them easier to abuse. In this article, we highlight problems with these so-called abuse-deterrent opioid formulations.
FDA Calls for Withdrawal of Dangerous Opioid That Never Should Have Been Approved
August 2017
Worst Pills, Best Pills News Editor Dr. Michael Carome assesses the implications of the FDA’s recent request that a major pharmaceutical company remove from the market its reformulated extended-release opioid product.
Anti-Clotting Drugs Increase Risk of Dangerous Bleeding In the Head
August 2017
Millions of people in the U.S. take blood thinners or antiplatelet medications to prevent the formation of potentially harmful clots in the heart, large veins or arteries. In this article, we report new research that examined the risk of one of the most serious bleeding complications associated with these drugs: subdural hematomas in the head.
Food-Drug Interactions You Should Know About
August 2017
Although health care professionals often advise patients on whether the medications they are taking may interact with each other, they do not always discuss how various foods may interact with medications. Learn about some of these dangerous food-drug interactions and how to protect yourself.
Drugs That Cause Diarrhea
August 2017
Many medicines can cause diarrhea, which can be severe and life-threatening in some cases. Find out which drugs have this adverse effect.
Medications for Hair Loss
August 2017
Alopecia, or excessive hair loss, is a common problem among both men and women, and it can have a considerable negative impact on the body image and emotional well-being of affected individuals. In this article, we present our recommendations regarding drugs that are approved for treating hair loss.
Do Not Use Eluxadoline (VIBERZI) for Irritable Bowel Syndrome
July 2017
Eluxadoline was approved by the FDA in May 2015 for treating irritable bowel syndrome with diarrhea as the predominant symptom in adults. Learn about the drug’s serious adverse effects that outweigh its limited benefits.
Supplements Purported to Boost Female Sex Drive Were Tainted
July 2017
For years, the Food and Drug Administration has repeatedly warned the public about dietary supplements that have been spiked illegally with hidden drugs. Find out which dangerous drug is now showing up in dietary supplements that are being promoted for increasing sexual desire and libido in women.
Acid-Suppressing Drugs Associated with Serious Infectious Diarrhea
July 2017
In this article, we discuss how two families of commonly used stomach acid suppressants may make patients more susceptible to Clostridium difficile infection, which can lead to severe, sometimes life-threatening diarrhea.
Magnesium Supplements Not Helpful for Nighttime Leg Cramps
July 2017
Nocturnal or nighttime leg cramps (charley horses) are very common in adults, afflicting nearly half of those over the age of 50. Find out why magnesium supplements are not the solution for this often distressing condition.
“Natural” Teething Remedies Also May Be Deadly
July 2017
Parents may be tempted to try assorted teething remedies for their infants. Learn about certain homeopathic products for teething that have been recalled because they were linked to a large number of serious injuries in infants.
Questions & Answers
July 2017
In this month’s Question & Answer section, we respond to a reader's question about how patients with high blood pressure should increase their dietary intake of potassium.
Benefits of Probiotics Remain Unproven
June 2017
The food and dietary supplement industries have been swift to capitalize on the excitement surrounding the microbes living on or within our bodies by selling products that contain probiotics, or live microor¬ganisms purported to improve health by altering the microbiome. In this article, we explain which claims about probiotics have been tested in clinical trials — and why many probiotic supplements are very likely a waste of money.
A Prescription for Making Medicines More Affordable in the U.S.
June 2017
Learn about landmark legislation recently introduced in the U.S. Senate that would lower the cost of prescription medications for all Americans, increase access to drugs for consumers and hold pharma¬ceutical corporations accountable for wrongdoing.
Drugs That Are Most Likely to Land Patients in the Emergency Room
June 2017
Many adverse drug reactions are severe enough to cause serious injury, hospitalization and even death. Find out which outpatient medications are most likely to cause adverse events that necessitate a visit to the emergency room.
Study Uncovers Serious Underreporting of Harms in Orlistat’s Trials
June 2017
For many years, we have designated the weight-loss drug orlistat (XENICAL, ALLI) as Do Not Use because it exposes patients to serious risks that greatly outweigh its minimal benefits. In this article, we describe data from a new study showing that orlistat’s side effects were seriously underreported in published medical journal articles for the clinical trials that the drugmaker conducted to support the drug’s approval.
Side Effects of Blood Pressure Drugs Often Unmonitored, Unaddressed
June 2017
We discuss new studies confirming that the widely used angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers can potentially harm the kidneys and cause dangerous elevations in blood potassium levels. These studies also indicated that many doctors are not heeding recommenda¬tions to look out for these side effects.
FDA Warning: Commonly Used Diarrhea Drug Can Cause Life-Threatening Heart Problems
May 2017
Find out which commonly used prescription and over-the-counter diarrhea medications can cause dangerous abnormal heart rhythms and cardiac arrest if taken at higher-than-recommended doses.
Nominee for FDA Commissioner: Too Cozy With Big Pharma
May 2017
On March 10, President Donald Trump nominated Dr. Scott Gottlieb to be the next FDA commissioner. Worst Pills, Best Pills News Editor Dr. Michael Carome explains why Gottlieb’s appointment would fur¬ther accelerate a decades-long trend in which FDA leadership too often makes decisions that are aligned more with the interests of the pharmaceutical industry than with those of patients.
Researchers Fight to Undo a Depression Drug's Dark History
May 2017
We describe the troubling story of how a pharmaceutical company manipulated the scientific literature to inappropriately promote the use of citalopram (CELEXA) for the treatment of de¬pression in children and teens despite the fact that the drug was not approved by the FDA for this use.
Budesonide and Formoterol (SYMBICORT): A Review
May 2017
The lung diseases asthma and chronic obstructive pulmonary disease together afflict 40 million Americans and can result in disability and life-threatening complications for many affected individuals. In this article, we present our recommendations for using SYMBICORT, a combination of the long-acting beta agonist formoterol and the inhaled corticosteroid budesonide, to treat these lung diseases.
Nonsurgical Treatments for Urinary Incontinence
May 2017
Urinary incontinence — the inability to control the passage of urine — is a widespread problem that affects an estimated 25 million American adults. Learn about lifestyle changes and non-drug therapies that should be the first-choice treatments for incontinence, as well as the best drugs to use as second-choice treatment options.
Study Rebuts Health Benefit Claims for Off-Label Testosterone
April 2017
Overall, use of testosterone medications in the U.S. grew by nearly 10-fold from 2000 to 2011, and by 2013, more than 5 million U.S. prescriptions for testosterone were being filled annually. In this article, we discuss new research findings showing that testosterone products fail to provide benefit to many of the men who are using them.
Big Pharma’s Self-Promoting Media Campaign
April 2017
Worst Pills, Best Pills News Editor Dr. Michael Carome warns readers not to be deceived by the slick advertising campaign recently launched by the Pharmaceutical Research and Manufacturers of America — the leading industry trade group representing brand-name pharmaceutical companies.
Many Psoriasis Drugs Unsafe During Pregnancy
April 2017
Find out which medications that are used to treat psoriasis (a chronic condition that causes patches of scaly and inflamed skin) are particularly dangerous during pregnancy because they carry well-established, high risks of birth defects.
Maker of ‘Female Viagra’ Sued as Sales Fizzle
April 2017
Flibanserin (ADDYI) was billed as the "female Viagra" because it was intended to increase sexual desire in women with "hypoactive sexual desire disorder," or low interest in sex. Learn why this dangerous drug fortunately has failed to be the blockbuster that many expected it to be.
A Review of Anti-Seizure Drug Levetiracetam
April 2017
Levetiracetam (KEPPRA, ROWEEPRA, SPRITAM) and its long-acting variant, levetiracetam extended-release (KEPPRA XR), are approved by the FDA for preventing seizures in patients with epilepsy. Find out who is most likely to benefit from using these drugs and what adverse reactions to watch out for when taking them.
New Research Links Testosterone to Risk of Dangerous Blood Clots
April 2017
We review the results of a new study demonstrating that patients using testosterone products have a significantly increased risk of developing life-threatening blood clots in large veins, most often in the legs.
Beware of Ads for ‘Memory- Enhancing’ Dietary Supplement
March 2017
If you regularly watch nightly national news on TV, you have probably seen ads promising improved memory if you take the dietary supplement apoaequorin (PREVAGEN). Learn why these claims from the maker of PREVAGEN represent an apparent elaborate hoax.
FDA Removal of Black-Box Warning Sets Dangerous Precedent
March 2017
In October 2014, Public Citizen joined four other consumer advocacy and research groups to petition the FDA to strengthen the existing black-box warning on the label of the smoking cessation drug varenicline. In December, the agency instead decided to move recklessly in the opposite direction by removing the black-box warning from the label. In this article, we discuss the dangerous precedent set by this decision.
Year in Review: Troubling New Drug Approvals in 2016
March 2017
In this article, we discuss three new drugs approved by the FDA in 2016 that Worst Pills, Best Pills News has identified as ineffective or lacking in evidence to support key claims made on products’ labels. The drugs discussed include one intended to treat a rare form of muscular dystrophy and two supposedly abuse-deterrent opioid pain drugs.
Spironolactone: Review of a ‘Water Pill’
March 2017
Spironolactone is a diuretic (water pill) that has been used for decades to treat certain patients with high blood pressure, heart failure, swelling (water retention) and other conditions. Find out who is most likely to benefit from using this drug and who should avoid it because of its dangerous adverse effects.
Medications for Bipolar Disorder
March 2017
Bipolar disorder, also known as manic depression, is a serious chronic mental illness that afflicts approximately 5.4 million people in the U.S. In this article, we review the benefits and safety of several drugs that are commonly used to treat this disorder.
Lorcaserin (BELVIQ): Another Do Not Use Diet Drug
March 2017
Learn about the unacceptable dangers posed by lorcaserin, a diet drug that was approved by the FDA in 2012 and that has similarities to the previously banned diet drug fenfluramine.
FDA Requires Stronger Warnings for Commonly Used Antibiotics
February 2017
One of the biggest-selling but most overprescribed classes of antibiotics in the U.S. is the family called fluoroquinolones. Learn why the FDA required the addition of new black-box warnings to the labels of these antibiotics that describe risks of several disabling and potentially permanent side effects.
21st Century Cures: Gift to Big Pharma, Bad Deal for Patients
February 2017
Worst Pills, Best Pills News editor Dr. Michael Carome discusses the dangerous giveaways to the pharmaceutical and medical device industries that are buried within the massive 21st Century Cures Act passed by the lame-duck Congress in December 2016.
Beta Blockers Not for Most Hypertension Patients
February 2017
Beta blockers have long been a mainstay of hypertension drug treatment. While these drugs remain useful for some patients, we now no longer recommend them as the starting treatment for hypertension except in special circumstances. Read this article to find out why our views on beta blockers have changed.
Dangerous Dosing Errors Rampant Among Parents Measuring Liquid Medications
February 2017
This article presents the results of new research showing that many parents make significant errors when measuring the dose of liquid medications for their children. Learn how to minimize dosing errors when administering children’s liquid medications.
Buprenorphine for Opioid Addiction
February 2017
From 2000 to 2014, almost half a million people died of drug overdoses in the U.S. Many of these deaths were fatal opioid overdoses, which have quadrupled in the U.S. since 1999. Learn why buprenorphine now outpaces methadone as a treatment of choice for opioid addiction.
Questions & Answers
February 2017
In this month's Questions & Answers section, we respond to two readers' important questions about our recent article about the treatment of attention deficit hyperactivity disorder.
Drugs That Increase the Risk of Falling
January 2017
Falls remain by far the leading cause of injuries among adults age 65 and older in the U.S. In this article, we identify many of the drugs that can increase your risk of falling and offer advice on how to protect yourself from fall-related injuries.
Patient Safety Advocates, Industry Spar Over Off-Label Promotion
January 2017
Worst Pills, Best Pills News editor Dr. Michael Carome discusses highlights of the debate between the pharmaceutical and medical device industry and patient safety advocates at a recent FDA public hearing regarding the agency’s rules on off-label promotion — the pharmaceutical and medical device industry practice of promoting prod¬ucts for unapproved uses.
Many Older Adults Do Not Take Blood Pressure Medications as Prescribed
January 2017
Keeping high blood pressure under control is essential to preventing long-term complications of hypertension, including cardiovascular disease, stroke and kidney failure. Learn about the steps you can take to boost your adherence to your blood pressure medication treatment.
Do Not Use Linaclotide (LINZESS) for Irritable Bowel Syndrome or Constipation
January 2017
Find out why the risks of linaclotide far exceed its benefits for treating patients with irritable bowel syndrome and constipation, and learn about safer alternative treatments for these conditions.
FDA Advisory Committee Split on Black-Box Warning on Varenicline (CHANTIX)
January 2017
In October 2014, Public Citizen joined four other consumer advocacy and research groups to petition the FDA to strengthen the existing black-box warning on the label of the smoking cessation drug varenicline. Find out why the FDA now is considering moving recklessly in the opposite direction by removing the black-box warning from the label.
Questions & Answers
January 2017
In this month Questions & Answers section, we respond to a reader's question about whether calcium-containing antacids, such as TUMS, for heartburn may increase the risk of adverse cardiovascular events.
The Rising Cost of Generic Drugs
December 2016
The ever-increasing prices for prescription medications are often in the news these days, with some products carrying eye-popping price tags of more than $100,000 per year. Typically the highest prices are for newer, brand-name products. Yet a more surprising pricing story has begun to emerge over the past few years: the rising cost of generic medications.
FDA Leadership Ignores Science, Approves Ineffective Drug
December 2016
Learn why the decision by FDA’s leaders to approve a new medication for a rare muscle disorder, over the strenuous objections of the agency’s scientific experts, threatens to undermine public health.
Endocrine Society Recommends Against Routine Use of Compounded Hormones
December 2016
In this article, we explain why FDA-approved bioidentical hormone medications are preferred over custom-mixed (compounded) products for treating hormone-related disorders.
Ropinirole: A Second-Choice Drug for Parkinson’s Disease
December 2016
In this article, we explore recent research showing that the older drug levodopa-carbidopa has a more favorable benefit-risk balance than ropinirole and other newer dopamine agonists for initial treatment of early Parkinson’s disease.
Dangers of Sleep Drug Suvorexant Still Outweigh Minimal Benefits
December 2016
Find out why Public Citizen’s Health Research Group has designated suvorexant as Do Not Use and what steps you can take to improve your sleep without relying on medications.
EpiPen Maker Mylan Becomes Lead Pharma Villain
November 2016
Worst Pills, Best Pills News editor Dr. Michael Carome discusses how drug manufacturer Mylan assumed the banner of most infamous price gouger among pharmaceutical corporations in the U.S.
Adding Aliskiren to an ACE Inhibitor in Heart Failure Harmful, Without Benefit
November 2016
For many years we have recommended never combining the high blood pressure medications aliskiren and ACE inhibitors. In this article, we review new research showing that this combination of drugs poses unacceptable risks in heart failure patients and provides no additional benefit over an ACE inhibitor alone.
Oral Treatments for Hypothyroidism
November 2016
Not all thyroid hormone replacement medications are the same, and some are not even approved for use in the U.S. Learn which of these medications you should take — and which ones you should not take — to treat hypothyroidism (underactive thyroid).
Insulin Glargine (TOUJEO): Do Not Use for Seven Years
November 2016
TOUJEO is a newer, long-acting, once-daily insulin approved by the Food and Drug Administration for the treatment of Type 1 and Type 2 diabetes in adults. Learn why you should avoid using this drug until at least 2022.
News Brief for November 2016
November 2016
In this month's News Brief section, we report on action taken by the Food and Drug Administration to add important new warnings to the labeling of all opioid and benzodiazepines drugs.
Commonly Used Antibiotic Can Cause Serious Psychiatric Side Effects
November 2016
Find out which commonly used antibiotic can cause psychosis, hallucinations, delirium, mood disorders, sleep disturbances and cognitive impairment.
A Guide to Treatment for ADHD
October 2016
The number of children diagnosed with attention deficit hyperactivity disorder (ADHD) and treated with drugs has increased dramatically over the past decade. Learn the steps needed for an accurate ADHD diagnosis and understand the variety of treatments available before working with your child's doctor on a plan for treatment.
Most Patients’ Groups Opposing Medicare Drug Pricing Reforms Have Ties to Big Pharma
October 2016
Worst Pills, Best Pills News editor Dr. Michael Carome discusses the implications of a recent Public Citizen report showing that the overwhelming majority of patient groups that opposed a recent Medicare Part B plan to rein in drug costs have financial ties to pharmaceutical corporations.
Treatment of Bacterial Skin Infections
October 2016
Bacterial skin infections are very common, resulting in several million visits to health care professionals annually. In this article, we explain the best treatment options for different types of bacterial skin infections.
FDA Issues Multiple Warnings For Newest Class of Diabetes Drugs
October 2016
Over the past year, the Food and Drug Administration has issued a series of new warnings about serious and, in some cases, potentially fatal events linked to the newest class of diabetes drugs. These drugs, known as "flozins," are being heavily promoted in TV ads. Learn more about these newly identified dangers and why you should avoid all flozins.
First-Choice Treatment for Young Children With ADHD Largely Underused
October 2016
For children younger than 6 with ADHD, drug treatment is not the first choice. Find out the non-drug approach recommended by the American Academy of Pediatrics that parents and teachers can use to manage these very young ADHD patients.
Questions & Answers
October 2016
In this month Questions & Answers section, we respond to a reader's question asking for advice on how patients can find out if their doctors have taken money from the pharmaceutical industry.
A Price-Gouging, Tax-Dodging Drug Company
September 2016
Find out which leading drugmaker has reaped billions of dollars in profits in the U.S. by charging unaffordable prices for its hepatitis C drugs, then shifting those profits offshore, enabling it to dodge nearly $10 billion in U.S. taxes.
New Gout Drug Lesinurad (ZURAMPIC) Too Dangerous
September 2016
The FDA's approval of lesinurad despite serious safety concerns and limited evidence of benefits represents another example of the agency's reckless approach to the oversight of prescription drugs. Read our independent analysis of the data considered by the FDA when it approved this new gout drug and our assessment of why you should not use it.
Gabapentin and the Criminal Manipulation of Science, a Decade Later
September 2016
In 2004, Parke-Davis, the manufacturer of gabapentin (NEURONTIN), pleaded guilty to felony charges for illegal marketing of the drug, including for "off-label" uses not approved by the FDA. Protect yourself and your loved ones from unnecessary risk by learning which claims about gabapentin are supported by sound science and which are not.
Questions & Answers
September 2016
In this month Questions & Answers section, we offer advice on how readers can approach their doctors about medicines that we have designated as either Do Not Use or Do Not Use for Seven Years.
Opioids and Benzodiazepines: A Deadly Combination
September 2016
Readers of Worst Pills, Best Pills News are aware that all benzodiazepine tranquilizers and sleeping pills, except for alprazolam (XANAX) and clonazepam (KLONOPIN), are now considered Do Not Use drugs. In this article, we explain why combining these drugs with opioid painkillers could kill you.
Do NOT ‘Go With the Flow’ for Dabigatran (PRADAXA)!
September 2016
Dabigatran is one of several new, heavily promoted anticoagulant drugs (blood thinners) approved by the FDA in recent years. Learn why you should ignore the television ads and not use this dangerous drug.
Doctors Accepting Bribes, Betraying Patients
August 2016
Worst Pills, Best Pills News editor Dr. Michael Carome discusses the recent arrest of two former drug company employees for allegedly running a brazen scheme to bribe doctors to prescribe millions of dollars' worth of a powerful synthetic opioid.
Incretin-Mimetic Drugs: Do Not Use to Treat Diabetes
August 2016
Incretin mimetics, one of the newer classes of diabetes drugs, are widely prescribed in the U.S. Find out why Public Citizen's Health Research Group recommends against using any of these medications.
Starting Beta Blockers Before Noncardiac Surgery May Be Harmful
August 2016
Beta blockers, which are widely used and effective in treating high blood pressure, heart disease and heart failure, are often started in patients prior to surgery in an effort to prevent cardiovascular complications. Learn why starting beta blockers immediately before undergoing surgery may be dangerous.
Proton Pump Inhibitors Linked to Dementia in the Elderly
August 2016
In this article, we review new research linking use of the heartburn and ulcer medications known as proton pump inhibitors to an increased risk of dementia.
Supplements for Age-Related Macular Degeneration
August 2016
Numerous high-dose dietary supplements are now broadly marketed to promote general eye health. Find out who can benefit from — and who should not take — these supplements and which ingredients to look for on the label.
News Brief for August 2016
August 2016
In this month's news briefs, we report on the FDA's decision to require new black-box warnings in the labeling of all immediate-release opioid drugs about the risks of abuse, addiction, overdose and death, as well as the agency's recent drug safety alert reminding consumers not to purchase over-the-counter chelation products. We also discuss the decision of a major drugmaker to terminate its involvement in the marketing of an inhaled form of insulin.
Proton Pump Inhibitors Might Cause Chronic Kidney Disease
July 2016
Public Citizen's Health Research Group has long warned about the serious risks of the commonly used group of heartburn drugs known as proton pump inhibitors. In this article, we discuss new research suggesting that chronic kidney disease is another potential side effect of these drugs.
Antibiotic Misuse: Dangerous for Everyone
July 2016
When health care providers prescribe antibiotics to patients who do not need them, these drugs endanger both the patients taking them and the public at large. Find out why.
Vitamin D for Preventing Falls in the Elderly: Less Is Safer
July 2016
Many people take vitamin supplements to promote bone and muscle health. But taking too much vitamin D may have dangerous consequences. Read this article to find out how much vitamin D is safe.
Drugs That Cause Sun-Related Skin Reactions
July 2016
Summer is a terrific time for healthy outdoor activities, such as walking, hiking, biking and swim¬ming. But for an unlucky few, certain medications can lead to adverse skin reactions following exposure to the sun. Find out whether you are at risk and how to protect yourself.
Drug-Induced Hair Loss
July 2016
For most people with hair loss, the condition usually is age-related or due to the genes they inherited from their parents. But for some patients, the cause of the problem can be found in the medicine cabinet. Learn about some commonly used medications that can cause hair loss.
Industry Money Undermines the Doctor-Patient Relationship
June 2016
Worst Pills, Best Pills News editor Dr. Michael Carome highlights new research showing that the large sums of money pharmaceutical and medical device companies funnel to physicians too often play an inappropriate role in physicians’ prescribing decisions.
Prostate Drugs Increase Risks of Falls, Fractures
June 2016
Symptoms of benign (noncancerous) prostate enlargement afflict most men age 60 or older. In this article, we discuss new research showing that a group of drugs often used to treat this condition slightly increase the risk of falls and fractures. We offer important advice on how to minimize these risks.
What Is a Drug Label?
June 2016
Drug labels provide important information regarding the benefits and risks of prescription medications. In this article, we offer guidance on where to find these drug labels and identify the sections of the label that provide the most useful information for patients.
Important Questions About Shingles
June 2016
Shingles is a very common disease caused by the chicken (herpes zoster) virus. Elderly adults are particularly vulnerable to developing this painful and sometimes debilitating condition. Learn the facts about shingles and how you can lower your risk of developing it.
SPIRIVA for COPD: Find Out Which Inhaler Is Safe
June 2016
Tiotropium (SPIRIVA) is a frequently prescribed drug administered via oral inhalers for chronic obstructive pulmonary disease (COPD). The drug is available in two types of inhaler devices. One of these should never be used. Find out which one.
A Guide to Drugs for Uncomplicated Urinary Tract Infections
May 2016
Urinary tract infections (UTIs) are very common, accounting for more than 10 million visits to doctors’ offices and 2 million to 3 million emergency department visits in the U.S. in 2007. Hear our take on which antibiotics are safest for treating these infections.
FDA to Investigate Effect of Using Cartoon Characters to Peddle Drugs
May 2016
Animated characters are a feature of an increasing number of TV ads for prescription drugs. Find out why the FDA is concerned that these characters may mislead consumers about the risks and benefits of the medications being promoted and what the agency intends to do about this.
Memantine: Still a Poor Choice for Alzheimer’s Disease
May 2016
Memantine (NAMENDA) recently has been one of the drugs for Alzheimer’s disease most heavily promoted through direct-to-consumer advertising. Learn why we have designated memantine as Do Not Use.
Questions & Answers
May 2016
In this month’s Question & Answer feature, we respond to a reader’s request to explain why we recommend use of bisphosphonates for certain patients with osteoporosis despite our warnings about their risks.
Another Look at First-Generation Antihistamines
May 2016
Last month, we discussed the risks and benefits of second- and third-generation antihistamines for treatment of nasal allergies. In this second of a two-part series, we explain why first-generation or "sedating" antihistamines are not a safe option for managing nasal allergies.
Responsible Disposal of Prescription Drugs
May 2016
For various reasons, many prescribed medications go unused. Such leftover medications can pose a hazard to family members, especially young children, and the environment. Find out the best ways to safely dispose of unused prescription medications.
New FDA Commissioner: Unfit for Duty
April 2016
Worst Pills, Best Pills News editor Dr. Michael Carome explains why the new FDA Commissioner, who was confirmed by the Senate in February, was a poor choice to lead such a critically important agency of the U.S. Public Health Service.
Is XARELTO Really the 'Right Move' for Patients With Blood Clots or Risk for Stroke?
April 2016
If you watch TV, you likely have seen ads touting the advantages of the new oral antico-agulant (blood thinner) rivaroxaban (XARELTO). Learn why we have designated this drug as Do Not Use for Seven Years (until at least July 2018).
Treatment for Nasal Allergies: An Updated Review
April 2016
With spring time pollen counts soaring, many patients with seasonal nasal allergies will be looking for relief from allergy medications. Learn the best available treatments to stay safe and relatively symptom-free during allergy season and throughout the year.
The Best Drug for Severe Acute Low Back Pain
April 2016
Low back pain is the fifth most common reason for outpatient doc¬tor visits and leads to 2.6 million emergency room visits in the U.S. every year. This article reviews results of the newest research on which pain relievers are safest and most effective for managing severe low back pain.
Fluoroquinolones Linked to Life-Threatening Blood Vessel Complications
April 2016
In this article, we discuss results of new research linking the widely overused fluoroquinolone antibiotics to an increased risk of life-threatening damage to the body’s largest blood vessel, the aorta.
Year in Review: Troubling New Drug Approvals in 2015
March 2016
Learn about six new drugs approved by the FDA in 2015 that Worst Pills, Best Pills News has identified as dangerous or ineffective. The drugs include two for lowering high cholesterol levels, one for removing excess fat below the chin, and another for treating gout, among others.
CDC Seeks to Rein In Overprescribing of Opioids for Chronic Pain
March 2016
Since 1999, more than 140,000 people in the U.S. have died from overdoses related to opioid pain medication. Worst Pills, Best Pills News editor Dr. Michael Carome applauds a new proposal from the Centers for Disease Control and Prevention to rein in the overprescribing of opioids and reverse this rising death toll.
News Brief for March 2016
March 2016
In this month’s news brief, we report on the Department of Justice taking long-overdue action against a Dallas-area compounding pharmacy for making contaminated drugs and for unsanitary production conditions.
Feds Finally Crack Down on Illegal Dietary Supplement Makers
March 2016
Too often, consumers are exposed to dietary supplements that have been spiked illegally with hidden drug ingredients or contaminated with other potentially dangerous substances. In this article, we report on recent legal actions taken by the FDA, the Department of Justice, and the Federal Trade Commission to stem the flow of these dangerous products.
Some SNRIs Useful for Depression; Avoid Others
March 2016
This article explores one of the newer classes of drugs for treating depression: serotonin-norepinephrine reuptake inhibitors (SNRIs). Find out which SNRIs are safe for treating depression and which should be avoided.
New Biologic Drugs for Rheumatoid Arthritis: Which Are Safe?
March 2016
Patients with rheumatoid arthritis have a wide array of medication choices for reducing joint pain and inflammation and slowing the progression of joint damage. The most potent such drugs are a group of medications known as disease-modifying anti-rheumatic drugs (DMARDs). Learn about the serious risks posed by these drugs and when they should be used.
FDA Joins Hands With Industry to Weaken Its Own Rules
February 2016
Worst Pills, Best Pills News editor Dr. Michael Carome expresses outrage over disclosures that senior Food and Drug Administration representatives colluded with a leading medical device trade association in writing legislation that would weaken regulatory standards for medical devices.
St. John’s Wort: No ‘Wonder Remedy’ for Depression
February 2016
St. John’s wort, an over-the-counter herbal supplement, has been around for centuries, and many patients have been using it in recent years to self-medicate for depression. In this article, we explain why St. John’s wort should not be used to treat this disease.
Commonly Used Gout, Kidney Stone Drug Too Dangerous for Unproven Uses
February 2016
Allopurinol (LOPURIN, ZYLOPRIM) is an appropriate first-choice drug for treating gout and kidney stones caused by excess uric acid levels in the blood or urine. But you should not use allopurinol to treat high blood uric acid levels if you don’t have these disorders. Read this article to learn why.
Drugs That Cause Loss of Bladder Control
February 2016
Urinary incontinence, or loss of bladder control, is a common and often embarrassing problem that can have a huge impact on quality of life. Find out which drugs can cause this problem.
News Brief for February 2016
February 2016
In our news brief this month, we report on two recent warnings issued by the Food and Drug Administration about the diabetes drugs known as SGLT2 inhibitors, more commonly known as “flozins.” This family of drugs, all designated as Do Not Use, includes canagliflozin (INVOKAMET, INVOKANA), dapagliflozin (FARXIGA) and empagliflozin (JARDIANCE).
Still No Good Evidence That Nonstatin Drugs Prevent Heart Attacks and Strokes
February 2016
Statins have long been a mainstay of treatment for patients with high LDL (“bad” cholesterol) and cardiovascular disease. In this article, we explain why you should avoid combining a nonstatin cholesterol-lowering dug with a statin.
New Evidence That Off-Label Drug Use Increases Risk of Harm
January 2016
Worst Pills, Best Pills News editor Dr. Michael Carome discusses the implications of new research showing that patients taking prescription drugs for uses not approved by the Food and Drug Administration are more likely to suffer adverse reactions.
Health Canada Warns of Dangerous Drug Interaction
January 2016
Learn why Health Canada, an agency similar to the Food and Drug Administration, warned Canadian consumers not to combine repaglinide-containing diabetes medications (PRANDIN or PRANDIMET) with the anti-platelet drug clopidogrel (PLAVIX).
Questions & Answers
January 2016
In this month’s Questions & Answers feature, we address readers’ questions about using several non-traditional treatments for osteoarthritis pain, including cetyl myristoleate, s-adenosylmethionine or SAMe, and aloe vera.
Drug Treatments for Chronic Heart Failure
January 2016
For the approximately 5 million Americans suffering from chronic heart failure, there is a wide array of lifesaving drug treatments. Find out our take on the most recent expert guidelines for treating this disease.
Omega-3 Fatty Acid, Antioxidant Supplements Useless for Improving Cognitive Function
January 2016
In this article, we review results from a well-designed clinical trial funded by the National Institutes of Health that debunks the cognitive health claims for dietary supplements containing omega-3 fatty acids or the antioxidants lutein and zeaxanthin.
Dangers of Post-Surgery Delay in Resuming Blood Pressure Drugs
January 2016
Patients taking drugs to treat high blood pressure often are directed to stop their medication at least 24 hours before surgery. Learn why restarting these medications as soon as possible after surgery could save your life.
Inhaled Insulin AFREZZA Ineffective, Can Damage Lungs
December 2015
Find out why this new form of insulin, which is inhaled as a powder, is a dangerous alternative to injected forms of insulin and never should have been approved by the Food and Drug Administration for the treatment of diabetes.
Outrage Over Price Gouging by Pharma Companies Reaches New Heights
December 2015
Worst Pills, Best Pills News editor Dr. Michael Carome examines the possible implications of the rising tide of public anger over the high prices charged by pharma¬ceutical companies in the U.S.
Dangerous Atypical Antipsychotics Minimally Effective for Depression
December 2015
Some powerful antipsychotic drugs originally developed to treat schizophrenia now have been approved to treat depression. Learn about the serious side effects of these drugs that make it advisable to explore other, safer options for managing depression.
Long-Acting Opioids: Extra Caution Needed
December 2015
In this article, we review new evidence suggesting that long-acting opioids are associated with a higher risk of unintentional life-threatening over¬doses than short-acting forms of these drugs.
Many Atrial Fibrillation Patients With Lowest Stroke Risk Receive Unnecessary Blood Thinners
December 2015
A recent study revealed that some cardiologists prescribe blood thinners to atrial fibrillation patients who don’t need them because their risk of stroke is very low. Read this article to learn who these patients are.
News Brief for December 2015
December 2015
In our news brief this month, we discuss Public Citizen's recent petition to the Food and Drug Administration to correct the labeling of a new drug approved for treatment of an uncommon sleep disorder in totally blind people. The agency mistakenly approved a label that expanded the drug's use to nonblind patients.
Drug Industry’s Unacceptable Delays in Reporting Adverse Events To the FDA
November 2015
Worst Pills, Best Pills News editor Dr. Michael Carome discusses disturbing results from a recent study revealing that pharmaceutical companies too often violate the law by failing to promptly report unexpected serious adverse events linked to use of their products. Delays in report¬ing such events undermine a key component of our nation’s system for monitoring the safety of prescription drugs.
News Brief for November 2015
November 2015
In our news brief this month, we report on the Food and Drug Administration's reckless decision to approve flibanserin (ADDYI), the first drug to treat hypo¬active sexual desire disorder in premenopausal women.
Insulin Pumps Need More Scrutiny, Say American and European Diabetes Groups
November 2015
Insulin pumps have been promoted as an important technological advancement in diabetes care. Find out why Public Citizen’s Health Research Group considers these devices too dangerous to use.
Update on the Long-Term Treatment Of Chronic Obstructive Pulmonary Disease
November 2015
In this article, we provide a detailed update of the various drugs available for the long-term management of chronic obstructive pulmonary disease (COPD). Learn which drugs are safest for treating COPD and which ones we have designated as Do Not Use.
Drugs That Cause Hearing Problems
November 2015
For most people with hearing loss, the condition likely is age-related or due to long-term exposure to loud noise. But for some patients, the cause of the problem can be found in the medicine cabinet. Learn about some commonly used medications that can cause hearing disorders.
Questions & Answers
October 2015
In this month's Question and Answers feature, we respond to readers' questions about our June article on injected drugs for age-related macular degeneration.
Initial Ruling in Industry Lawsuit Threatens FDA's Regulation Of Drugs
October 2015
Learn more about a recent federal court decision that threatens to return us to the days of the late 19th and early 20th centuries, when snake-oil salesmen touted "remedies" that were too often ineffective — and sometimes dangerous.
Liraglutide (SAXENDA) for Weight Loss
October 2015
Find out why the recently approved high-dose form of liraglutide, which was originally marketed for treatment of Type 2 diabetes, is not a safe option for managing weight loss
Often-Misused Fluoroquinolone Antibiotics Pose Serious Risks
October 2015
Fluoroquinolones are the biggest-selling and most overprescribed classes of antibiotics in the U.S. Learn why Public Citizen's Health Research Group designates two of the five available fluoroquinolones as Do Not Use and why the other three should be used only in limited circumstances.
More Evidence Linking Hormone Therapy To Cardiovascular Harm in Postmenopausal Women
October 2015
In this article, we discuss the most recent evidence linking the use of hormone replacement therapy in women after menopause to increased risk of heart attacks, strokes and other serious cardiovascular problems.
News Brief for September 2015
September 2015
In our news brief this month, we report on a recent FDA safety warning about permanent disfiguring skin color changes caused by a medication patch used for treating attention-deficit hyperactivity disorder.
Selling More Drugs by Misrepresenting Their Safety
September 2015
Last year, the FDA proposed a guidance that would give drug com¬panies free rein to tell doctors that medications are less dangerous than the FDA has concluded. Find out the serious threat posed by this guidance and action you can take to stop it.
Questions & Answers
September 2015
In response to our recent article on osteoporosis, a reader asks for our opinion regarding the use of the dietary supplement PROSTEON for this disorder. See our independent assessment of this supplement.
Warning From FDA on Prescription Drops for Ear Pain
September 2015
In July, the FDA announced that the agency will be requiring manufacturers to stop selling 16 types of prescription ear drops. These drugs have never been approved as safe and effective for their marketed uses. Find out the names of these drugs so you can protect yourself and your family members from these potentially harmful and unproven remedies.
VYVANSE for Binge Eating: Old Pill, New ‘Disease’
September 2015
Don't fall prey to a drug company's slick marketing campaign of a dangerous drug recently approved by the FDA for treatment of a newly designated disease called "binge eating disorder."
FDA Bolsters Warnings About Heart Attack, Stroke Risks for Commonly Used Pain Drugs
September 2015
Worst Pills, Best Pills News editor Dr. Michael Carome discusses the FDA’s recent safety alert announcing that the agency is strengthening existing warnings in the product labels for all non-aspirin nonsteroidal anti-inflammatory drugs about increased risk of heart attack and stroke.
DUAVEE, Hot Flashes and Bone Health
September 2015
Learn why the new combination of conjugated estrogens plus bazedoxifene (DUAVEE) is a bad choice for treating hot flashes and improving bone health in menopausal women.
Pharma Companies Buying Old Drugs, Dramatically Increasing Prices
August 2015
Learn about one disturbing pharmaceutical industry trend contributing to skyrocketing prices of certain lifesaving medications that have been on the market for decades.
Antibiotics, Common Heartburn Drugs And Spread of Potentially Fatal Intestinal Infection
August 2015
Proton pump inhibitors, a widely used class of heartburn drugs, and essentially all antibiotics increase your risk of C. difficile infections, which can cause severe, even life-threatening diarrhea illness. Read this article to find out how to protect yourself from this dangerous infection.
Update: Treatment of Chronic Asthma
August 2015
Asthma is a common disease afflicting more than 16 million American adults and 6 million children. Find out the safest and most effective options for managing this chronic lung disease.
Questions & Answers for August 2015
August 2015
A reader asks whether a recent change in her thyroid disorder symptoms could have been caused by switching from a brand name to generic thyroid hormone replacement drug. See our advice regarding concerns about such thyroid medication changes.
Risks but No Benefits to Taking Newest Drugs For Type 2 Diabetes
August 2015
The airwaves are filled with ads promoting the newest class of diabetes medications, often referred to as “flozins.” In this article, we review the serious safety concerns that have prompted us to designate all flozins as Do Not Use.
Anticholinergics May Increase Dementia Risk in Elderly
August 2015
Learn about recent evidence suggesting that anticholinergic drugs — which include many antidepressants, antihistamines and overactive bladder control medications — may increase the risk for developing Alzheimer’s disease and other types of dementia in the elderly.
Public Citizen Shines a Light on Off-Label Promotion of Diabetes Drugs
July 2015
In a recent complaint to the FDA, we took several makers of diabetes drugs to task for direct-to-consumer ads that promote the drugs for unapproved uses. Find out the names of the drugs targeted in our complaint and the nature of the off-label uses being promoted in the ads.
New Study Reveals Many Patients at Risk for Dangerous Alcohol-Drug Interactions
July 2015
Recent research revealed that many patients consume alcohol while using drugs that may can cause dangerous side effects when combined with alcohol. Read this article to learn about the many ways alcohol can adversely interact with prescription and over-the-counter medications.
Industry Lawsuit Threatens FDA's Regulation of Drugs
July 2015
Worst Pills, Best Pills News editor Dr. Michael Carome discusses an unusual lawsuit filed by a drug company against the FDA that seeks to bypass the agency’s drug approval process and the prohibition against off-label promotion.
Eight Treatments Commonly Used for Osteoarthritis Pain
July 2015
Patients with osteoarthritis have many treatment options. Find out which ones are safest for relieving osteoarthritis pain.
News Brief for July 2015
July 2015
In this month’s news brief, we discuss Public Citizen’s recent petition to the FDA calling for a ban on all oral forms of a commonly used antifungal drug.
Risk of Sudden Death With Some Hypertension Drug-Antibiotic Combinations
June 2015
Find out which commonly used antibiotic can increase your risk of sudden death if it is combined with either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), which are among the most widely prescribed drugs in the U.S.
More Evidence of Dietary Supplements’ Dangers, Lack of Quality
June 2015
Worst Pills, Best Pills News editor Dr. Michael Carome discusses three recent events that reinforce the importance of being wary when considering the use of dietary supplements.
News Briefs for June 2015
June 2015
In our news briefs this month, we report on a recent FDA warning about the dangers of relying on over-the-counter homeopathic products to treat asthma. We also discuss the FDA’s very first approval of a biosimilar, which is essentially a generic version of a biologic drug.
More Dietary Potassium Can Reduce Occurrence of Hypertension, Amount of Drugs Needed for Its Treatment
June 2015
Learn why increasing the amount of potassium in your diet can help lower your blood pressure and reduce your risk of suffering a stroke. To help readers assess their potassium intake, we offer a list of potassium-rich foods.
Canada Issues Warnings on Alzheimer’s Disease Drugs
June 2015
Health Canada, the Canadian equivalent of the U.S. Food and Drug Administration, recently warned physicians and patients about safety concerns regarding two drugs commonly used to treat Alzheimer’s disease. Find out the names of these drugs and the newly identified serious adverse events linked to them.
Injections for Age-Related Macular Degeneration
June 2015
Age-related macular degeneration is a leading cause of blindness and serious decreases in vision among patients age 50 and older. In this article, we provide our independent expert assessment of the available drug treatments for this disorder.
A Guide to Treatments for Osteoporosis
May 2015
Drug treatment can prevent broken bones in some women with osteoporosis. But drugs are not always necessary and can cause harmful side effects, especially when treatment lasts longer than needed. Read this article to learn who should take osteoporosis drugs, which drugs to take and for how long.
FDA Belatedly Requires Warnings About Heart Attack, Stroke Risks for Testosterone Products
May 2015
On March 3, the Food and Drug Administration finally announced that it was requiring that the labels of all approved prescription testosterone products include a warning about the possible increased risk of heart attacks and strokes. Worst Pills, Best Pills News editor Dr. Michael Carome criticizes the agency for recklessly dragging its feet prior to requiring these warnings.
Painkiller Tramadol Increases Risk of Low Blood Sugar
May 2015
For years, Public Citizen’s Health Research Group has designated tramadol as a Do Not Use drug. We discuss results of a new study providing an additional reason for avoiding tramadol: The drug has been linked to the occurrence of dangerously low blood sugar.
Falls in Elderly People: The Role of Blood Pressure Drugs
May 2015
Recent studies have confirmed that a significant cause of falls in the elderly is medication (and often overmedication) with drugs for high blood pressure, resulting in blood pressures low enough to increase the risk of falling — with attendant fractures and head injuries. Learn who is most at risk and what the blood pressure goal should be for patients age 60 or older.
Studies Cast Doubt on the Benefits of Raising HDL (‘Good’) Cholesterol
May 2015
This article discusses evidence from recent research that calls into question the benefits of taking drugs, such as niacin, to raise blood levels of high-density lipoprotein (HDL), often called “good” cholesterol.
Further Evidence Confirms Danger Of Blood Pressure Drugs Used Together
April 2015
Patients should never take more than one of the following drugs used to treat high blood pressure at the same time: an angiotensin-converting enzyme (ACE) inhibitor, an angiotensin II receptor blocker (ARB), and aliskiren. Learn why doing so could have serious, even fatal consequences.
Health Insurers Find New Way To Discriminate Against Sick Patients
April 2015
Worst Pills, Best Pills News editor Dr. Michael Carome reviews a new scheme being perpetrated by some health insurance companies in order to maximize profits: to discourage certain high-cost patients from enrolling in their health plans.
A Look at Treatments for Rosacea
April 2015
Rosacea is a chronic skin condition affecting 13 million Americans. Find out steps to take to prevent symptom flare-ups, and learn which topical drug therapies are most effective and safest for treating this condition.
Owner, Lead Compounding Pharmacist of Drugmaker Linked to Meningitis Outbreak Charged With Murder
April 2015
In December 2014, a federal grand jury in Boston indicted 14 executives and employees of a Massachusetts compounding phar¬macy on 131 criminal charges in connec¬tion with a deadly nationwide fungal meningitis outbreak. Learn the shocking details of how the company put the lives of thousands of patients around the country at risk.
Benzodiazepines: Widely Prescribed, Dangerous Sleep and Tranquilizer Drugs
April 2015
This article discusses recent research showing increasing frequency of benzodiazepine use as people get older in the U.S. We also review results of a new study showing a possible link between use of these drugs and an increased risk of developing Alzheimer’s disease.
Ten Rules for Safer Drug Use
March 2015
Patients often wonder what steps they can take to minimize their chances of suffering a serious adverse drug reaction. This article reviews 10 simple rules developed by Public Citizen’s Health Research Group for ensuring safer drug use.
Public Citizen Highlights Efforts By Biologics Industry to Maintain Monopolies
March 2015
In his editor’s column, Dr. Michael Carome discusses how companies that make biologic medications are using their political clout to price-gouge and maintain indefinite monopolies on their products, costing consumers billions of dollars.
Public Citizen Joins Other Groups in Requesting Additional Warnings on CHANTIX Label
March 2015
In October 2014, Public Citizen joined four other consumer advocacy and research groups to petition the FDA to require stronger warnings on the label of the smoking cessation drug varenicline (CHANTIX). Learn about the drug’s severe psychiatric and neurological side effects that could potentially lead to fatal consequences.
Big Pharma’s Drug Assistance Programs: Harmless Charity?
March 2015
Pharmaceutical companies market patient assistance programs as a goodwill solution to assist patients who are struggling to pay for expensive prescription drugs. Find out why these programs may encourage physicians to prescribe more expensive drugs instead of less expensive, equally effective alternatives, including generic products.
More on Overprescribing Statins
March 2015
The most recently issued prescribing guidelines for cholesterol-lowering statin drugs were partly based on a new patient risk calculator that significantly overestimates patients’ risk of developing cardiovascular disease. Learn how this overestimation will lead to overprescribing of statin drugs to patients who will not benefit from using them.
News Brief for March 2015
March 2015
In our news brief this month, we report on the FDA’s recent approval of a new, high-dose, extended-release formulation of the opioid drug oxycodone (HYSLINGA). Although this new version of the drug is designed to deter abuse, it may be more dangerous than other oxycodone products. Read this article to find out why.
Questions & Answers for March 2015
March 2015
In a new feature that will appear periodically in issues of Worst Pills, Best Pills News, we respond to some selected questions posed by our readers. In this month’s issue, we respond to questions regarding (a) whether the widely advertised drug adalimumab (HUMIRA) is a new wonder drug, and (b) what should you do if you are already taking rivaroxaban (XARELTO).
With Some Drugs, Crushing Tablets Or Opening Capsules Could Have Fatal Consequences
February 2015
Patients who have difficulty swallowing pills will sometimes crush tablets or open capsules and sprinkle the resulting powder, fragments or granules into food or liquids. Other patients will resort to chewing their pills before swallowing. Find out the dangers posed by taking such measures.
Congress, Justice Department Investigate Spiked Generic Drug Prices
February 2015
In 2014, alarm bells sounded as the prices of many commonly used generic drugs spiked, in some cases by staggering amounts. Read Dr. Michael Carome’s column to find out how Congress and the Justice Department are investigating this price gouging.
New Warnings on Common Heartburn Drugs: Too Little — and, for Some, Too Late
February 2015
After a more than three-year delay and a Public Citizen lawsuit filed against the FDA, the agency finally responded to our petition for stronger label warnings on a class of medications, known as proton pump inhibitors, commonly used to treat heartburn. This article discusses the new warnings that the FDA has required in response to our petition.
Does $760m a Year of Industry Funding Affect the FDA’s Drug Approval Process?
February 2015
This reprint of a British Medical Journal column by Health Research Group founder and former Worst Pills, Best Pills News editor Dr. Sidney Wolfe discusses how user fees paid by the drug industry to the FDA have compromised the agency’s drug review process and undermined drug safety.
New Recommendations to Prevent Complications During Pregnancy
February 2015
In 2014, the U.S. Preventive Services Task Force issued new recommendations regarding the use of low-dose aspirin by pregnant women to reduce the risk of developing preeclampsia, a potentially life-threatening condition. Learn about the risk factors for this serious condition and who is most likely to benefit from taking low-dose aspirin.
Gambling, Hypersexuality And Compulsive Shopping: Drugs That Make You Lose Control
January 2015
Find out which drugs used to treat Parkinson’s disease, restless legs syndrome and the hormone disorder hyperprolactinemia can cause uncontrollable impulsive behaviors, including compulsive gambling and shopping, hypersexuality, and binge eating.
Republican Takeover of Senate Imperils Drug Safety
January 2015
Given the changes in the makeup of the U.S. Senate following the November elections, Congress is likely to pass new legislation that will weaken the FDA’s rules for ensuring that drugs are safe and effective. Read Dr. Michael Carome’s column to find out why.
New Evidence of Flaws in Approach to PRADAXA Dosing
January 2015
One of the supposed major advantages of the anticoagulant dabigatran (PRADAXA) touted by its manufacturer is that patients can take a fixed dose of the drug and do not need to undergo periodic monitoring with blood tests to adjust the dose. This article presents new research data that casts doubt on the safety of this fixed-dose approach.
News Briefs for January 2015
January 2015
In a new feature that will appear periodically in issues of Worst Pills, Best Pills News, we highlight recent important news items related to drug safety. In this month’s news briefs, we report on (a) a recent FDA warning about over-the-counter drugs that can make you drowsy; (b) action taken by the Federal Trade Commission against a company for false advertising of green coffee beans as a miracle weight loss remedy; and (c) the American Academy of Neurology’s position statement cautioning against the use of narcotic drugs for treatment of chronic noncancer pain.
CRESTOR Lacks Any Health Benefit for High Cholesterol; Likely to Increase Risk of Diabetes
January 2015
Since 2003, Public Citizen’s Health Research Group has advised readers not to use rosuvastatin (CRESTOR). Learn about the newest research indicating that rosuvastatin is more dangerous than other available statin drugs.
Sleep Disorder Treatment for Blind Persons May Be Marketed More Widely
January 2015
The FDA recently approved a drug for treatment of a sleep disorder that occurs primarily in people who are totally blind. Find out the name of this new drug and learn about concerns that the company may seek to market the drug to a much wider population of patients who are not blind.
Pregabalin (LYRICA): OK for Certain Seizures, but Not Pain
December 2014
LYRICA is heavily promoted for treatment of chronic pain due to fibromyalgia and other conditions. Learn why Public Citizen’s Health Research Group advises against using the drug to treat these painful conditions.
Sunshine Law Exposes Vast Industry Payments to Physicians
December 2014
In his editor’s column, Dr. Michael Carome discusses the implications of data recently released by the federal government that reveals the staggering amount of money drug and medical device companies are paying doctors and teaching hospitals.
Restless Legs Syndrome: Overdiagnosed and Overtreated
December 2014
In this review of restless legs syndrome (RLS), we discuss the limitations of the available drug treatments for the disorder and the nondrug approaches that are the safest options for people with mild to moderate RLS symptoms.
Albiglutide (TANZEUM): Another Me-Too Drug for Type 2 Diabetes
December 2014
Read about the dangers posed by albiglutide, yet another new diabetes drug designated as Do Not Use by Public Citizen’s Health Research Group because it offers no unique benefits but does pose unique risks.
Adding NSAIDS or Aspirin to Anticoagulants Increases Bleeding Danger
December 2014
If you are one of the millions of patients in the U.S. who take blood thinners on a long-term basis to prevent potentially harmful clots in the heart, veins or arteries, read this article to learn why you should avoid taking NSAIDS or aspirin unless absolutely necessary.
New Cholesterol Treatment Guidelines Recommend Statins for More Patients
November 2014
One year ago, the American College of Cardiology and the American Heart Association released controversial new guidelines on treating high cholesterol. Get Public Citizen’s Health Research Group’s independent take on these new guidelines.
The FDA Should Not Be Promoting Products It Regulates
November 2014
In his editor’s column, Dr. Carome takes the FDA to task for using the agency’s homepage to promote specific medical devices and medications. By becoming the promoter of the products it regulates, the FDA undermines its objectivity and independence.
Combining Diabetes Drugs With Certain Antibiotics May Cause Dangerous Drops in Blood Sugar Levels
November 2014
Serious adverse reactions often occur when different drugs are taken together. Find out which antibiotics diabetic patients taking glipizide (GLUCOTROL, GLUCOTROL XL) or glyburide (DIABETA, GLUCOVANCE, GLYNASE) should avoid because of an increased risk of life-threatening drops in blood sugar levels.
FDA Approves Suvorexant, Latest Dangerous Sleep Drug
November 2014
For many years, Public Citizen’s Health Research Group has recommended against using sleeping pills to treat insomnia. This article reviews the serious risks of the newest sleep medication approved by the FDA.
New Warnings for Bone Drug Denosumab (PROLIA)
November 2014
Learn about new warnings recently issued by the FDA about the bone drug denosumab, a medicine previously designated as Do Not Use by Public Citizen’s Health Research Group.
Benzocaine Teething Gels Associated With Life-Threatening Condition
October 2014
Learn why benzocaine-containing gels and liquids should never be used to treat teething discomfort and about the actions Public Citizen’s Health Research Group has taken to end the use of these dangerous products in infants.
Generic Drugs: Don’t Let Appearances Fool You
October 2014
Stopping beneficial medications threatens patient health. In his monthly editor’s column, Dr. Michael Carome discusses an intriguing new study showing that patients are more likely to stop taking important medications when pharmacies substitute one generic version of a drug for another differing in shape or color.
Widely Used Prostate Cancer Treatment Not Beneficial for Most
October 2014
Many men with localized prostate cancer are being treated unnecessarily with a commonly used class of drugs. Find out which drugs are being overused.
Eszopiclone (LUNESTA): Too Dangerous at Any Dose
October 2014
The Food and Drug Administration’s recent recommendation to lower the starting dose of the insomnia drug eszopiclone is insufficient to address the drug’s dangers. Learn why Public Citizen’s Health Research Group continues to designate eszopiclone as Do Not Use.
Severe Allergic Reactions to Acne Treatments
October 2014
Many commonly used over-the-counter acne products pose a risk of serious allergic reactions in children and adults. This article provides information on how to minimize the risk when starting treatment with one of these products.
New Diabetes Drug Dapagliflozin (FARXIGA): Risks Outweigh Benefits
September 2014
Learn about the many dangers of one of the newest diabetes drugs approved in the U.S., dapagliflozin, which has been designated as Do Not Use by Public Citizen’s Health Research Group.
A Dangerous Gap in FDA Recall Authority
September 2014
The recent refusal of two companies to immediately recall potentially contaminated sterile drugs when requested to do so by the Food and Drug Administration highlights a serious gap in the agency’s regulatory authority. Learn more about the companies involved and the action that must be taken by Congress to address the public health threat posed by such industry obstinacy.
New Blood Pressure Treatment Guidelines Released
September 2014
In December 2013, new guidelines for treatment of high blood pressure were issued by a group of experts appointed by the National Institutes of Health. The guidelines stirred much controversy in the medical community. Get the Public Citizen Health Research Group’s independent take on these new guidelines.
Should You Take Aspirin to Prevent Pancreatic Cancer?
September 2014
Perhaps you have seen some of the recent newspaper coverage of a National Cancer Institute-funded study suggesting that long-term aspirin use may be associated with a decreased risk of pancreatic cancer. In this article, Public Citizen’s Health Research Group reviews the study, compares it with earlier evidence and offers our recommendations.
A Brief Guide to Understanding Medical Studies
September 2014
News stories often excitedly report about the results of the latest medical study. Learn about the three main types of medical studies and find out which type provides the most reliable information for assessing the risks and benefits of drugs and other medical treatments.
New Atrial Fibrillation Treatment Guidelines Released
August 2014
Atrial fibrillation is one of the most common heart rhythm disorders, afflicting more than 2.7 million Americans. Learn about the most recent guidelines for treating this disorder, issued by the American College of Cardiology and the American Heart Association, and about Public Citizen’s Health Research Group’s assessment of those guidelines.
FDA’s Recent Action on Testosterone Products: Grossly Insufficient
August 2014
The FDA recently required manufacturers of all approved testosterone products to include a general warning on the product labeling about the risk of developing blood clots in veins. Find out why the new warning is dangerously incomplete.
Human Growth Hormone, ‘the Sweet Syringe of Youth’: Myths, Evidence and Controversy
August 2014
Numerous advertisements in magazines and on television and the Internet tout the miraculous age-reversing and bodybuilding properties of synthetic growth hormone treatment. This article critically reviews the evidence surrounding these health claims.
Type 2 Diabetes Drug Alogliptin Causes Liver Toxicity
August 2014
Learn why Public Citizen’s Health Research Group has designated the following three new Type 2 diabetes drugs as Do Not Use: alogliptin (NESINA), the combination of alogliptin and metformin (KAZANO), and the combination of alogliptin and pioglitazone (OSENI).
New Study Shows Increased Risk Of Death With Sleeping Pills And Tranquilizers
July 2014
For many years, Public Citizen’s Health Research Group has recommended against using tranquilizers and sleeping pills to treat insomnia and anxiety. This article presents new evidence linking use of these drugs to an increased risk of premature death.
Assessing FDA Performance: Approval Speed Is Not the Answer
July 2014
In his editor’s column, Dr. Carome takes the Food and Drug Administration (FDA) to task for its obsessive focus on drug approval times as a measure of agency success. Focusing on such metrics to assess the agency’s performance is misguided and dangerous.
Genetic Tests Not Useful for Managing Warfarin Dosing, According to New Studies
July 2014
In 2007, the FDA enthusiastically suggested that newly available genetic tests would help doctors select the best dose of warfarin — one of the oldest and most widely prescribed blood thinners (anticoagulants) — for individual patients. Find out why the FDA’s enthusiasm about the promise of genetic testing in the management of warfarin dosing was premature and overstated.
High-Dose Selenium May Increase Prostate Cancer Risk
July 2014
Dietary supplement companies tout the mineral selenium as possibly being able to reduce the risk of prostate cancer and other diseases. Learn about new evidence showing that high doses of selenium may actually increase the risk of prostate cancer.
Do Not Use Steroid Injections for Back Pain
July 2014
Steroid injections are very commonly used to treat back pain. Find out why Public Citizen’s Health Research Group now recommends against such treatment.
Risks of Ospemifene For Menopause-Related Pain During Intercourse
June 2014
Learn about the dangers of the heavily promoted drug ospemifene (OSPHENA), which was recently approved by the FDA to treat pain during sexual intercourse, and about much safer alternatives for treating this condition.
FDA 'Partnerships' Incompatible With Agency's Regulatory Role
June 2014
In his editor’s column, Dr. Carome explains why the FDA’s distorted view of itself as a part¬ner with the pharmaceutical and medical device industries is incompatible with its role as the regulator of these industries and its mission to protect public health.
Further Evidence That CELEBREX Is a Do Not Use Drug; New Designation of Diclofenac (VOLTAREN) as a Do Not Use Drug; and Other Do Not Use NSAIDS
June 2014
Learn about new research that provides further evidence affirming our designation of celecoxib (CE¬LEBREX) as a Do Not Use drug and that has prompted us to reclassify diclofenac (VOLTAREN) from Limited Use to Do Not Use. Also find out which NSAIDs are least likely to cause adverse cardiovascular events, such as heart attacks and strokes.
Important Information to Know About Clopidogrel
June 2014
Clopidogrel is a widely used drug for reducing the risk of a new heart attack or stroke or cardiovascular death in patients who have had a recent heart attack, stroke or established pe-ripheral vascular disease. This article provides a detailed overview of the drug, including potential serious side effects and important precautions to follow when taking the drug.
Do Not Use MIACALCIN Nasal Spray or Other Calcitonin-Containing Drugs for Osteoporosis
May 2014
Learn about the dangers of using calcitonin-containing drugs for treatment of osteoporosis and find out why the Food and Drug Administration, in contrast to regulators in Canada and Europe, has acted recklessly by failing to ban nasal calcitonin products.
Proposed FDA Rule Change on Generic Drug Labeling Essential for Patient Safety
May 2014
In a desperate attempt to prevent the FDA’s November 2013 proposed rule on generic drug labeling from being finalized, the generic drug industry has offered up many groundless objections. In his editor’s column, Dr. Carome outlines the reasons why this rule must be implemented to ensure patient safety.
Type 2 Diabetes: A Guide to Prevention and Treatment
May 2014
The treatment options for Type 2 diabetes can be overwhelming. This article provides a comprehensive summary of our independent expert views on the best approaches for preventing and treating this common disease.
Beta Blockers Save Lives in COPD Patients After Heart Attacks
May 2014
If you have chronic obstructive pulmonary disease (COPD) and suffer or have suffered a heart attack, you should be treated with a beta blocker. Such treatment could save your life. Find out why and learn which beta blockers are safest for COPD patients.
Risk of Serious Harm from Sodium Phosphate Products for Constipation
April 2014
The FDA recently issued an alert about serious, and even fatal, kidney and heart risks from exceeding the recommended dose of over-the counter sodium phosphate products used to treat constipation. This article reviews the data that led to the FDA’s alert and provides advice on how to avoid these serious harms when taking sodium phosphate products.
The FDA Must Aggressively Inspect Foreign Drug Factories
April 2014
On Jan. 23, 2014, the FDA issued an order banning from the U.S. market any drugs produced by a factory owned by a leading manufacturer of generic drugs sold in the U.S. Read this commentary to find out why.
NUVARING: Do Not Use
April 2014
Do not use the contraceptive drug NUVARING. Multiple studies have shown increased risk of blood clotting with drugs from the same family as NUVARING, and some have shown increased risk with NUVARING itself. Learn about safer, equally effective forms of contraception that are widely available.
Calcium Channel Blockers Plus Most Macrolide Antibiotics: A Dangerous Combination
April 2014
Learn about new evidence demonstrating the dangers of combining calcium channel blockers, a widely used class of drugs for treating high blood pressure, with the commonly used macrolide antibiotic clarithromycin and other related antibiotics. Also find out which macrolide antibiotic does not have this dangerous interaction with calcium channel blockers.
Testosterone Use Linked to Increased Risk of Heart Attacks
March 2014
There is a growing body of evidence indicating that testosterone treatment exposes men to an increased risk of adverse cardiovascular events, such as heart attack and stroke, as well as death. This article reviews the results of two recently published studies that provide the most compelling evidence yet linking testosterone use to increased cardiovascular risk.
A Bad Law on Compounded Drugs Made Worse by Poor FDA Messaging
March 2014
In his first column as the editor of Worst Pills, Best Pills News, Dr. Michael Carome highlights the major flaws in a new federal law on compounded drugs and criticizes the FDA’s initial failure to clearly communicate to the public that compounded drugs are riskier than FDA-approved drugs.
Year in Review: Troubling New Drug Approvals of 2013
March 2014
Learn about new drugs approved by the FDA in 2013 that Worst Pills Best Pills has identified as dangerous or ineffective. The drugs include two for diabetes, two for chronic obstructive pulmonary disease and an over-the-counter drug for overactive bladder, among others.
Escalating Criminal and Civil Violations: Pharma Has Corporate Integrity? Not Really
March 2014
Dr. Sidney Wolfe, founding editor of Worst Pills, Best Pills News, concludes that “there is pathological lack of corporate integrity in many drug companies.” Read this article to find out why.
The New Diabetes Drug Canagliflozin (INVOKANA)
February 2014
Do not use the newly approved diabetes drug INVOKANA. It offers no benefits over existing drugs but can result in serious risks, including hypotension and impaired kidney function, outlined in the article.
Passing the Editorial Baton for Worst Pills, Best Pills News and WorstPills.org
February 2014
Learn about the new editor of the Worst Pills, Best Pills newsletter and website, Dr. Michael Carome. The founding editor, Dr. Sidney Wolfe, will continue writing articles for the newsletter, including some of his new regular columns for the British Medical Journal.
Painkiller Patches Cause Accidental Deaths in Children
February 2014
The FDA has announced that accidental exposure to a prescription narcotic patch has been fatal to children. Learn what precautions to take to protect the young people around you.
How Effective Are Antidepressants for Depression?
February 2014
Some degrees of depression are less likely to respond to treatment with an antidepressant. This article reviews the evidence and evaluates 27 different antidepressants, labeling many as Do Not Use or Limited Use.
Do Not Use Paroxetine (BRISDELLE) For Treatment of Hot Flashes
January 2014
A newly marketed drug for treating hot flashes of menopause, BRISDELLE, is a lower dose of the familiar antidepressant PAXIL. This article discusses its risks and barely-evident effectiveness.
Selling Amphetamine-Emblazoned Athletic Shirts Versus Overselling Amphetamines: A Tale of Two Entrepreneurs
January 2014
When the manufacturer of the amphetamine ADDERALL criticized a Los Angeles boutique for selling T-shirts emblazoned with the drug’s name, it stated that the shirts “glorify[y] the misuse and diversion of a federally controlled prescription drug.” But the pharmaceutical company itself was cited by the Food and Drug Administration for overpromoting the drug to increase sales.
Hormone Replacement Therapy: Use at the Lowest Dose for the Shortest Amount of Time
January 2014
The dangers of hormone replacement therapy (HRT) are in direct proportion to the length of time for which they are used. This article discusses strategies for keeping dosage and exposure to a minimum and recommends only using HRT for debilitating hot flash symptoms. Nondrug remedies for milder symptoms also are discussed.
FDA Restricts, EMA Moves to Ban Ketoconazole Tablets
January 2014
A dangerous and easily substituted antifungal drug presents yet another example of Europeans being more protected from dangerous medicines by their regulatory authorities than Americans.
All Sleeping Pills Are Still Risky, But Safer Alternatives Exist
December 2013
We oppose the use of all sleeping pills, based on experts’ findings that “nonpharmacological treatments not only cause fewer side effects, but … can sustain long-term improvements more successfully than pharmacological treatments.” Read this article to learn about some suggested nondrug approaches.
Lax FDA Ethics Policy Helps Pharma
December 2013
Public Citizen stopped the chair of an FDA advisory committee from being the star attraction at an expensive conference for drug industry personnel. The planned session was intended to help the industry more easily get drugs approved by FDA advisory committees. Such activity demeans and undermines the crucial advisory committee process and highlights the need for an explicit FDA ethics policy.
Life-Threatening Liver Toxicity Linked to Supplement
December 2013
Yet another dietary supplement — this one intended for weight reduction and body-building — turns out to have life-threatening toxicity. In this case, the supplement has been linked to an outbreak of acute hepatitis.
When EMA and FDA Decisions Conflict: Differences in Patients or in Regulation?
December 2013
Are Americans more resistant to the risks and more likely to benefit from certain drugs than Europeans? Or is the European Medicines Agency (EMA) more resistant than the U.S. Food and Drug Administration (FDA) to the drug industry’s desire to get approval for drugs with unique risks but without compensating benefits? This article discusses two recently FDA-approved diet drugs deemed too unsafe for Europeans.
Unproven Laxative Widely Used for Childhood Constipation
December 2013
Learn about the problems of a common over-the-counter laxative, widely used for children but never approved for their use. We discuss the preferable, safer alternatives for treating constipation.
Zinc as a Cold Remedy: Still Waiting for Good Evidence
November 2013
A familiar and heavily promoted remedy for colds, zinc has not been found to have very important benefits. This article analyzes studies purporting to show such benefits.
The Continuing Exploitation Of Menopausal Women
November 2013
This month will see the launch of yet another highly promoted drug to treat the hot flashes of menopause. Like almost all of its predecessors, it has clear risks and also lacks strong evidence of usefulness.
Human Papilloma Virus Vaccine: Get the Facts
November 2013
Read about the benefits and risks of this vaccine for women, as well as the doubts about its usefulness for men.
Lomitapide: A Risky Drug for Lowering Cholesterol
November 2013
Lomitapide is approved to treat a rare genetic condition affecting approximately 300 people in the U.S. Yet it may ultimately be used to lower cholesterol in many more people, and it presents serious safety concerns.
New Government Guidelines Discourage Use of Antipsychotic Drugs in Dementia Care
October 2013
The federal government recently issued guidelines discouraging the use of antipsychotic medications to treat dementia in nursing home patients, promoting nonpharmacologic approaches to such treatment. Antipsychotic use among elderly patients is associated with increased chances of death, as well as other serious side effects.
Pharma’s Foreign Corrupt Practices Accompany Its Domestic Violations
October 2013
Several major drug companies have been implicated in scandals involving bribery of foreign doctors and illegal payments to foreign government officials. Learn which companies have paid penalties to the U.S. Securities and Exchange Commission to settle charges of corrupt foreign practices.
Steroid Treatment for COPD Exacerbations: Five Days Just as Effective as 14 Days
October 2013
If you or a loved one has chronic obstructive pulmonary disease (COPD), sometimes known as emphysema, and suffers from periodic acute COPD exacerbations requiring steroids, you should know that new research demonstrates that a five-day course of steroids for treating such exacerbations works just as well as a conventional 14-day course.
FDA Warns of Risks of Kidney Failure, Death With Hydroxyethyl Starch Solution
October 2013
The FDA recently issued a safety alert warning consumers that an intravenous fluid known as hydroxyethyl starch, sometimes used to replenish fluids in critically ill patients, can cause serious kidney damage and death. Learn about the basis for this warning and the available safer, less expensive alternatives.
FDA Moves to Loosen Restrictions on Diabetes Drug Avandia
September 2013
The FDA is considering relaxing the restrictions on the unacceptably dangerous drug rosiglitazone (AVANDIA) so that more people can access it, even while it remains banned in European countries.
TV Ads Expand the Market for Statins, At the Expense of the Public's Health
September 2013
Many doctors lack knowledge of how to prescribe statins appropriately. Learn what happens with this is combined with patients watching TV ads about these drugs.
Excitement Fades for Off-Label Alzheimer’s Treatment
September 2013
This article discusses the latest example of a failed drug for treating Alzheimer's disease. It also examines other ineffective FDA-approved drugs for treating the condition, as well as recent promising evidence for successful nondrug approaches, especially for those with mild cognitive impairment.
“Medicalizing Normality”: Potent Acid Reflux Drugs Overused in Infants
September 2013
The overuse of acid reflux drugs in adults has been well documented. Even worse, there is now evidence of an 11-fold increase in the use of these drugs to treat infants, mostly due to a benign condition for which the risks clearly outweigh any benefit. The article discusses effective, time-honored, nondrug remedies for this benign condition.
Niacin Ineffective in Treating Cardiovascular Disease
August 2013
A new study casts serious doubt on the usefulness of long-popular niacin products to treat or prevent cardiovascular disease.
Drug Company CEOs: Rewarded For Illegal Acts?
August 2013
CEOs of major drug companies are getting increasingly large benefits packages while their companies are paying massively larger criminal and civil penalties for illegal activities.
Do Not Use Over-the-Counter Oxybutynin Without First Checking With Your Doctor
August 2013
If you are thinking of using newly approved over-the-counter oxybutyin (OXYTROL FOR WOMEN) to treat overactive bladder, find out why you should first check with your doctor and learn about possible adverse reactions.
Diabetes Drugs Linked to Pancreas Disease
August 2013
Six recently approved diabetes drugs have been linked to an increased risk of pancreatitis and possibly pancreatic cancer.
Dr. Sidney Wolfe Turns Health Research Group Leadership Over to Dr. Michael Carome
July 2013
Dr. Carome will be directing Public Citizen’s Health Research Group, but Dr. Wolfe will still be working on the issues he has previously focused on, such as drug safety.
Off Diabetes Pills!
July 2013
A recently published article mirrors our now-35-year-old publication “Off Diabetes Pills” in suggesting alternatives to pharmaceutical treatment for a large proportion of adult-onset diabetics.
Asthma Drug Linked to Adverse Psychiatric Events
July 2013
The article reviews evidence that one of the biggest-selling asthma drugs lacks evidence of a unique benefit and has been found to cause a variety of adverse psychiatric events, including nightmares, hallucinations and aggressiveness, especially in children.
Chlorthalidone Versus Hydrochlorothiazide for Hypertension
July 2013
These two widely used diuretics (water pills) are equally effective in lowering blood pressure, but one of them is linked to many more adverse effects than the other.
Online Drug Promotion: A Prescription for Deception
July 2013
Learn tips for bypassing deceptive drug advertising to obtain truly unbiased, noncommercial health information.
Osteoporosis Drug May Lead to Atypical Fractures
June 2013
This article provides the newest information on a big-selling osteoporosis drug that can actually cause fractures as well as numerous other adverse reactions, further explaining its categorization on WorstPills.org as DO NOT USE.
Overprescribed Antibiotics Hurt One, Hurt All
June 2013
To protect yourself and others, when your doctor pulls out a pen to write a prescription for an antibiotic, you should ask him or her, especially if you are not feeling very sick: Do I really need this? And why?
Vitamin D Ineffective in Treating Osteoarthritis Of the Knee
June 2013
A recent study contradicted earlier beliefs by finding that vitamin D supplements (CALCIFEROL) given to people with osteoarthritis of the knee were ineffective in relieving knee pain or slowing damage to the knee joint.
Statins for Primary Prevention: Risks Without Benefits
June 2013
For people who have had heart attacks, strokes and other cardiovascular diseases, statins can prevent further damage. But for primary prevention — in people without such disease — a number of articles raise serious questions about whether the risks of statins outweigh the benefits.
Updates: Pain, High Cholesterol and ADHD Drugs
June 2013
These updates provide new information that has become available since we published our last articles regarding these three categories of drugs.
What Dangers Are Hidden in Your Weight-Loss Supplement?
May 2013
The article reviews evidence that quite often, to "enhance" the effectiveness of usually ineffective dietary supplements for weight loss, companies are illegally lacing such products with the dangerous, now-banned prescription weight-loss drug sibutramine (MERIDIA). Male-enhancement and muscle-building supplements also often illegally hide dangerous drugs in unknown quantities.
Accentuate the Positive, Eliminate the Negative
May 2013
A study documents how little information about important drug risks is disclosed by the drug salespeople who visit so many doctors. Their strategy for increasing sales: Accentuate the positive and almost entirely eliminate the negative about these medicines.
Rheumatoid Arthritis Drugs Linked to Increased Shingles Risk
May 2013
The article discusses evidence that five widely used drugs for rheumatoid arthritis can increase the risk of shingles. If you are using one of these drugs, learn what you can do to reduce such risks.
More on the New Stroke Prevention Drugs
May 2013
An update on last month's article about three relatively new, widely used stroke prevention drugs: dabigatran (PRADAXA), rivaroxaban (XARELTO) and apixaban (ELIQUIS).
New Hypertension Drug Poses Breathing Risks
May 2013
The article discusses possible breathing risks of nebivolol (BYSTOLIC)and how other, older drugs — just as effective as this relatively new high blood pressure drug — are preferred because more is known about their risks.
Hypertension Drugs Plus NSAIDs May Injure Kidneys
April 2013
Recent evidence points to increased acute kidney injury associated with combining nonsteroidal anti-inflammatory drugs (NSAIDs) with two antihypertensive drugs: a diuretic plus either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). Find out the names of these drugs. This is especially important for patients with hypertension, diabetes, congestive heart failure or chronic kidney disease, because such patients are routinely treated with diuretics, ACE inhibitors and ARBs.
Are European Women Different From U.S. Women?
April 2013
Last summer, the European equivalent of the Food and Drug Administration told Europeans not to use a particular drug for osteoporosis. Learn about this drug, which has been used by more than 100,000 U.S. women since then despite evidence of increased cancer risk.
Emerging Risks With New Stroke Prevention Drugs
April 2013
Learn about three new drugs to prevent stroke – so new that their risks relative to those of a much older drug, warfarin (Coumadin), are unknown.
Sleeping Pill Poses Safety Risks
April 2013
Learn about new warnings concerning multiple formulations of a widely used sleeping pill. The levels of the drug remaining in the blood the morning after use may be high enough to impair activities requiring mental alertness, including driving.
Overusing Medications Can Cause Headaches
March 2013
What kind of headache is not relieved by pain medications but actually caused by their frequent overuse? The article describes which painkillers can cause medication overuse headaches (MOH) when used too frequently over specified durations of time.
The FDA Must Restrict the Use of Prescription Narcotic Hydrocodone
March 2013
Find out why the most commonly prescribed drug of any kind in the U.S., hydrocodone, needs tighter restrictions to prevent emergency room visits, overdose deaths and other serious consequences of its massive overuse. Production and use of hydrocodone in this country amounts to 99 percent of that for the entire world. Is the rest of the world wrong and we are right?
Troubling New Drug Approvals in 2012
March 2013
Find out which drugs approved in 2012 have risks greatly exceeding their benefits or no meaningful benefits. If you are using any of the DO NOT USE drugs reviewed in the article, talk to your doctor before stopping their use.
Inappropriate Prescribing of Medicines in the Elderly: A Persistent Problem
March 2013
Approximately 20 percent of prescriptions for elderly patients in primary care settings are inappropriate, leading to adverse reactions that are entirely preventable. The article lists some of the most common inappropriately prescribed drugs.
Drug for Parkinson’s Disease and Restless Leg Syndrome May Increase Heart Failure Risk
February 2013
MIRAPEX (pramipexole) is a drug frequently used for restless leg syndrome, for which there are other safer, effective nondrug treatments, as discussed in the article. It also is used for Parkinson's disease. A recent review has found that this drug can increase the risk of heart failure. Find out how to recognize early symptoms of heart failure.
Harming Tuberculosis Patients Instead of Helping Them?
February 2013
Although there are not many cases in the United States, multiple drug-resistant tuberculosis (MDR TB) is a serious international problem. In a trial for a new drug for MDR TB, bedaquiline (SIRTURO), those receiving the drug were five times more likely to die than those receiving a placebo. Instead of looking into this more carefully, the Food and Drug Administration (FDA) approved the drug with the warning: “In one clinical trial, more deaths were seen in people who were treated with SIRTURO compared to people who did not receive SIRTURO.”
Treatment for Chronic Obstructive Pulmonary Disease
February 2013
Commonly known as emphysema, chronic obstructive pulmonary disease (COPD) affects an estimated 24 million Americans, only half of whom are diagnosed. This article presents recent information regarding the use of drug treatments, including inhaled anti-inflammatory steroids, as well as important nondrug treatments that can be used as an adjunct to drug therapy.
FDA Fails to Ban Toxic Lice and Scabies Treatment
February 2013
Even though safer treatments than lindane for lice and scabies are available, and despite Public Citizen’s efforts to ban this dangerous pesticide, the FDA continues to allow it on the market. This article discusses safer alternative treatments.
Warning: Nasal Sprays, Eye Drops Pose Serious Risk to Young Children
January 2013
Find out the serious risks, often requiring hospitalization, to infants and young children who accidentally swallow the liquids in nasal sprays or eye drops. The article lists the three most dangerous ingredients that are found in several big-selling brand name products, also listed in the article.
What Did Bayer Have in Common with Street Drug Dealers?
January 2013
Read about the history, from an investigation by the London Times, of how the world's first major drug company, Bayer, developed and got the trademark on one of the most dangerous over-the-counter drugs in history, Heroin. It was given this name because Bayer employees, given the drug as part of an experiment, felt "heroic" after using it. Read on.....
Benzodiazepines May Increase Dementia Risk
January 2013
Find out the names of 11 different drugs in this popular family of tranquillizers and sleeping pills that can increase the risk of dementia 30 to 40 percent in older adults.
Managing Herbal Medicines in Patients Undergoing Surgery
January 2013
Find out why, if you are using any of nine different popular dietary supplements and you are planning to have surgery, you need to tell your doctor so you can stop using them at a safe interval before your operation. The intervals range from at least 24 hours before surgery to two weeks, the latter the case for most of the nine supplements.
Vitamin D and Calcium for Bone Health: Getting the Right Amount
January 2013
This article reviews the latest recommendations on how much calcium and vitamin D are best for people. The right amount depends on both your age and whether you are male or female. Also, learn about the upper safe levels of both calcium and Vitamin D so that you do not take amounts that can be dangerous.
Fungal Meningitis Outbreak Highlights the Dangers of Compounding Pharmacies
December 2012
Public Citizen has a long history of opposing the dangerous under-regulation of large-scale pharmacy compounders such as the New England Compounding Center, which is at the center of the recent outbreak of fungal meningitis caused by contaminated injectable steroids. Learn how this current nationwide disaster, and its related deaths, could have been prevented.
Did Drug Companies and the FDA Collude to Harm Patients with Alzheimer’s Disease?
December 2012
The FDA sided with a large drug company in refusing to pull from the market a dangerous drug for treating Alzheimer's disease, which Public Citizen had asked the government to ban. What went wrong and why?
Updates: Migraine, Depression, Hypertension Drugs
December 2012
Topics discussed include evidence that overuse of migraine drugs may cause headache rather than relieve it. Also, a widely prescribed antidepressant, in higher doses, can cause heart arrhythmias, manifested as dizziness, palpitations or fainting. Finally, another widely used antidepressant can cause a life-threatening condition called neuroleptic malignant syndrome, which can include extremely high body temperature, fast heart rate, rapidly changing blood pressure and mental changes.
Do Not Use These Blood Pressure Drugs in Combination
December 2012
It is dangerous to take any of the 18 popular blood pressure drugs of one type (ACE inhibitors) in combination with any of the 14 blood pressure drugs of another type (ARBs). It also is dangerous to take a drug in either of these classes in combination with a newer high blood pressure drug, aliskiren (TEKTURNA). Find out why.
Settlements for Prosecution of Fraud by Big Pharma at Record High
November 2012
Find out the latest about the pharmaceutical industry continuing to remain the number one defrauder of the Federal government. Why does this continue and what are an increasing number of states doing about it?
A Healthy Dose of Skepticism Is Well Justified
November 2012
Find out why many doctors are skeptical of medical journal articles reporting the results of drug industry-funded studies. Apparently for self-interested reasons, the editor of a leading medical journal unfortunately disagrees with this healthy skepticism.
Over-the-Counter Topical Pain Relievers May Cause Burns
November 2012
Find out the names and ingredients of topical muscle and joint pain relievers that can cause moderate to severe local burns and how you can protect yourself.
Steroid Injections and Other Treatments for Lower Back Pain
November 2012
The recent epidemic of life-threatening and fatal infections from contaminated spinal steroid injections is a reminder of the larger issue of their use, even if not contaminated. The article discusses risks that remain even with properly manufactured medications, describing how patients and physicians should know when not to use steroids, consider the risks and benefits of the procedure, and understand other treatment options before using steroids to treat lower back pain.
Statins Frequently Cause Fatigue, Reduce Energy Levels
November 2012
Find out about the latest evidence that statins such as LIPITOR, LESCOL, ALTOPREV, MEVACOR, LIVALO, PRAVACHOL, CRESTOR and ZOCOR can cause fatigue and reduced energy levels, especially in women. The authors concluded that "These effects, germane to quality of life, merit consideration when prescribing or contemplating use of statins, particularly in groups without expected net morbidity/mortality benefit."
Dietary Supplements Offer Little to No Benefit and May Be Harmful
October 2012
The article reviews current evidence on 16 dietary supplements based on a large number of studies testing their effectiveness.
Editorial: The Seven-Year Rule for Safer Prescribing
October 2012
An invited editorial by Worst Pills, Best Pills News editor Dr. Sidney Wolfe in the October Australian Prescriber explains the factual basis for our recommendation not to use any new drug — except for relatively rare breakthrough drugs — until it has been on the market for seven years.
Diet and Exercise: Still the Best Medicine for Losing Weight or Keeping Fit
October 2012
The recent FDA approval of the first two new diet drugs in 13 years occasions our review of the safety problems of both drugs and the history of previous diet drugs, taken off the market because of serious cardiovascular dangers. Two recent well-controlled studies, one in adults and one in children, document the benefit of reasonable diet and exercise programs as the only safe and effective way to lose weight.
New Study on the Effectiveness of Statin Use in Women
October 2012
A recent study challenges the assumption that men and women with pre-existing cardiovascular disease benefit equally from the use of statins to prevent subsequent death or strokes.
Pfizer Includes Foreign Corrupt Practices Act Violations in Its Arsenal of Illegal Activities
September 2012
Learn about the wide range of countries in which Pfizer illegally bribed government officials in order to sell more of the company's drugs.
Smoking Cessation: What Works and What Doesn’t
September 2012
The article reviews the effectiveness and safety of a variety of drugs and strategies to help people stop smoking but also stresses the importance of interpersonal support for those trying to quit this deadly habit.
FDA Should Change Labels On Opioid Painkillers to Deter Misprescribing
September 2012
The article reviews a recent petition to the FDA seeking improvements on the labels of prescription opioids (narcotics). The label change would prevent drug companies from promoting these drugs for noncancer pain for dangerously long periods of time, at doses that are too high, and for uses other than severe pain in noncancer patients. The petition was signed by 37 public health experts, including leaders in the fields of pain medicine, addiction and primary care; the health commissioners of New York City and New York state; and Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.
New Advice on Treating Sinus Infections With Antibiotics
August 2012
Learn the details of the large problem of misprescribing antibiotics for sinusitis, symptoms of the condition, limited indications for antibiotic use and alternative treatments for this very common illness.
Settlement Not Enough to Deter Illegal Pharmaceutical Industry Behavior
August 2012
Find out how a seemingly large $3 billion criminal and civil penalty levied against GlaxoSmithKline — because of its small size relative to the drugmaker’s profits and the absence of jail time for any of the company’s officials — tacitly encourages drug companies to continue illegal activities.
Warning Against Benzocaine Treatment for Teething or Other Oral Pain in Babies
August 2012
Find out how using seemingly benign benzocaine gels and liquids for mouth and gum pain can lead to a rare but serious, and sometimes fatal, condition in infants and babies.
Antidepressants and Dementia in the Elderly
August 2012
We review a recent study concerning the lack of evidence that antidepressants are effective in elderly, demented people. Find out the risks involved with antidepressant use in this population and learn about the safer, more effective nondrug approaches to treating depression in elderly adults.
Increased Risk of Cardiovascular Death With Azithromycin and Levofloxacin
August 2012
We review recent evidence that azithromycin (ZITHROMAX, as in Z-PAK) and levofloxacin (LEVAQUIN), used for relatively short periods, significantly increased the risk of cardiovascular risks such as sudden cardiac death in some patients, compared to the risks in people not taking antibiotics. The overprescribing of these drugs is also discussed.
Fluoroquinolone Antibiotics Associated With Increased Risk of Retinal Detachment
July 2012
Find out the most common symptoms of the vision-threatening condition retinal detachment and how, although rarely, it can be caused by commonly used antibiotics such as ciprofloxacin (CIPRO) and levofloxacin (LEVAQUIN). We also discuss evidence that these antibiotics are overused.
Pfizer Succeeds at Slowing Loss of LIPITOR Sales After Patent Expires
July 2012
We discuss how Pfizer, after its patent on the billions-a-year-selling LIPITOR went off patent, used desperate means to delay giving patients options for much less expensive generic versions of the drug, marketed as atorvastatin.
Do Not Use Azilsartan (EDARBI) for High Blood Pressure
July 2012
Find out why we recommend that you do not use the recently approved high blood pressure drug azilsartan.
Update on Grapefruit Juice-Drug Interactions
July 2012
This article updates and expands our earlier list of drugs that can have harmful interactions with grapefruit juice. The list now includes 82 different drugs.
Do Not Use: Duloxetine (CYMBALTA)
June 2012
We review the dangers of the extremely popular drug duloxetine (CYMBALTA) and discuss why you should not use it to treat depression, anxiety or pain.
‘Dollars for Docs’
June 2012
Do large "gifts" from drug companies to doctors make a difference in the care that patients get? Find out how to view a partial list of drug companies to check whether your physician is getting such payments and how the government is delaying the disclosure of payments from all drug companies.
Preventing Heat-Induced Death and Illness
June 2012
This article lists practical steps to take to avoid death, hospitalization or other medical problems caused by heat stress. It also contains a list of 123 drugs that can impair your response to heat.
Some Anti-Hypertensive Drugs Increase the Risk of Gout
May 2012
The article lists many drugs that treat high blood pressure but can also increase the risk of gout. If you have gout, ask your doctor whether your dose of any of these drugs could be reduced or whether you should switch to a medication with a lower gout risk. However, hypertension control is of utmost importance.
Drug Companies Eager to Market And Sell to Older Adults but Not To Adequately Test Them
May 2012
The proportion of patients 65 or older in drug trial reports was lower than half the proportion in the treated population who were 65 or older, leading authors of a recent analysis to conclude that drugmakers should study an appropriate and larger proportion of older adults for drugs that will predictably be used by them.
Exenatide (BYDUREON) Injection to Control Blood Sugar in Type 2 Diabetes
May 2012
The article explains why you should not use the newly approved diabetes drug exenatide (BYDUREON), a long-acting dosage form of the previously approved BYETTA. Important safety concerns cited in the drug’s label and FDA warnings are also discussed.
Does Aspirin Prevent Heart Disease and Cancer?
May 2012
There is little doubt from earlier studies that using aspirin to prevent cardiovascular death in patients who already have cardiovascular disease is effective. A new review found that aspirin, taken daily or every other day in low doses for primary prevention of cardiovascular death in patients without existing cardiovascular disease, was not effective in these patients in either reducing cardiovascular death or death from cancer. It did, however, increase clinically important bleeding events in these patients.
Applying the Life-Saving 7-Year Rule: An Antiarrhythmic and 3 Anticoagulants
April 2012
Find out why you should not use four recently approved heart drugs — dronedarone (MULTAQ), prasugrel (EFFIENT), dabigatran (PRADAXA) and rivaroxaban (XARELTO) — for at least seven years.
More About Generic Drugs: A Trillion Dollar Finding
April 2012
A thorough review of studies that document the benefits — $1 trillion saved in the past 10 years — of our increasing use of generic drugs.
Benefits and Risks of Popular Allergy Medications
April 2012
This article discusses drugs you should and should not use as the allergy season commences.
A Review of the ‘Gliptin’ Diabetes Drugs
March 2012
Find out why you should not use any of the three recently-approved diabetes drugs known as "gliptins".
FDA’s About-Face on Financial Conflicts of Interest
March 2012
Last year, FDA Commissioner Dr. Margaret Hamburg told an audience at our D.C. Headquarters that FDA needed to allow more people with drug industry financial conflicts in order to get enough qualified doctors to fill its advisory committees. Find out why she was wrong and how she backed off this dangerous idea.
Sitagliptin With Simvastatin (JUVISYNC): A New Drug Combination to Avoid
March 2012
The article discusses the reasons why we have categorized JUVISYNC as a DO NOT USE drug.
Risk of Bleeding and Use of Antidepressants After Heart Attack
March 2012
The article discusses why taking certain antidepressants after a heart attack may increase the risk of bleeding. Find out which ones are the culprits.
Accidental Child Poisoning From Medications: A Growing Epidemic
February 2012
What kinds of prescription and over-the-counter products are responsible for the unintentional ingestion of these drugs by children? Such poisonings result in the hospitalization, admission to intensive care units and injury of thousands of children a year. How can they be prevented?
Overuse of Antibiotics in Children
February 2012
A very recent study found that each year, children in this country get 10 million antibiotic prescriptions that are clearly unnecessary, creating risks of adverse reactions without any possible benefit.
Fenofibric Acid (TRILIPIX) May Not Lower Heart Attack/Stroke Risk
February 2012
Over 15.2 million prescriptions were filled in 2010 for the brand-name or generic versions of two essentially identical drugs (fenofibrate [TRICOR] and fenofibric acid [TRILIPIX]) that clearly do not add any benefits to taking statin drugs alone but add to the risks.
Update: ‘Removal of Dr. Wolfe From FDA Advisory Committee Meeting Is Bad Policy’
February 2012
Shortly after allowing our editor only allotted time to present his views during the public session of an FDA committee meeting discussing the drugs YAZ and YASMIN, the FDA reconsidered and said he could participate as a committee member but would not be allowed to vote at the meeting. Ultimately, Dr. Wolfe participated as a nonvoting member, under protest.
Increased Prostate Cancer Risk With Vitamin E Supplements
February 2012
A recent study shows there is significant harm from using widely advertised vitamin E dietary supplements. Not surprisingly, the study was not funded by vitamin E manufacturers but by the U.S. National Institutes of Health.
Inadvertent Adverse Reactions With Commonly Used Drugs
January 2012
Find out how to prevent emergency hospitalizations from two commonly used drugs, warfarin (COUMADIN) and clopidogrel (PLAVIX). There are approximately 33,000 emergency hospitalizations a year from warfarin alone. This article includes a list of more than 50 drugs that can have harmful interactions with warfarin and/or clopidogrel.
Removal of Dr. Wolfe From FDA Advisory Committee Meeting Is Bad Policy
January 2012
Read about how the Worst Pills, Best Pills News editor was not allowed to vote on the safety of a big-selling drug because he thought it was unsafe.
Quetiapine (SEROQUEL) Drug Interactions and Heart Trouble
December 2011
Find out about 12 drugs that can interact with widely prescribed quetiapine -- 12 million prescriptions sold in 2010 -- to cause serious, sometimes fatal, heart arrhythmias.
More Patients Being Ripped off by Pay-for-Delay
December 2011
Patients pay more when brand-name drug companies legally "bribe" generic companies to delay the selling of less expensive products.
New Drug Interaction With Widely Used Antibacterial Drug and Common Diuretic
December 2011
Find out how using a combination of two commonly prescribed drugs (a total of 30 million prescriptions filled annually in the U.S.) can cause life-threatening increases in blood potassium, a risk that has led to hospitalization.
Saw Palmetto Extract: Ineffective for Enlarged Prostate Symptoms
December 2011
Read about the results of a study comparing higher doses of saw palmetto extract with a placebo for treating some common symptoms of benign prostate enlargement (such as urinary retention and incomplete emptying of the bladder).
Bladder Cancer Warning for Pioglitazone (ACTOS)
November 2011
Find out the full list of serious problems with pioglitazone (ACTOS) that cause it to be a DO NOT USE drug, of which bladder cancer is but the latest.
Dangerously Blind Faith in Drug Advertising and the FDA Drug-Approval Process
November 2011
Learn about the results of a study concerning people's faith in the validity of the FDA drug-approval process and in the agency's restrictions on drug advertising.
Proton Pump Inhibitors: Dangerous and Habit-Forming Heartburn Drugs
November 2011
PPIs are now one of the most widely used classes of prescription drugs, with an estimated one out of every 20 people in the developed world currently taking one of these medications. However, given that recent research shows PPIs may be habit-forming, that the majority of PPI use is probably inappropriate, with minimal or no benefit to the patient, and that new, life-threatening risks with long-term therapy are continually emerging, it is time for the medical community to re-evaluate the role of PPIs in everyday practice.
Do Not Use 5-Alpha Reductase Inhibitors for Enlarged Prostate
October 2011
Treatment for enlarged prostate is not always required. Find out which family of drugs is best should treatment be needed.
U.S. Approves Cancer Drugs Faster Than Europe
October 2011
We share the results of a 2011 Health Affairs study.
Risk for Men Using Inhaled Anticholinergic Drugs
October 2011
Read more for information on inhaled anticholinergic drugs and the risk they pose to older men with chronic obstructive pulmonary disease (COPD).
FDA Should Remove Weight-Loss Drugs ALLI and XENICAL From the Market
October 2011
Following our April 2011 petition to the FDA to have weight-loss drug orlistat removed from the market, we review the serious adverse effects associated with its over-the-counter and prescription forms.
Dangers of Taking Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers Together
September 2011
Find out how using a combination of two drugs, one from each of these two families, can increase the risks of kidney toxicity and dangerously higher blood levels of potassium compared to use of one of these two families of drugs alone. The article lists 10 different drugs in the first class and seven in the second class. Worse yet, most of the patients in the study were prescribed the combination to treat conditions for which the combination has not proven to be beneficial.
Hypocrites at Merck -- Not Just in Washington, D.C.
September 2011
Find out how Merck tried, unsuccessfully, to keep from being sued by stockholders who accused the company of withholding information about the risks of Vioxx.
New Heart-Risk Safety Warning for Varenicline (CHANTIX): Do Not Use Until 2013
September 2011
Find out why the FDA is now requiring patient warnings on this drug about an increased risk of cardiovascular adverse events in patients with existing cardiovascular disease. This adds to the growing list, including many psychiatric adverse effects, of problems associated with varenicline.
Warning About Surgical Mesh Devices Used in Women
September 2011
Each year 67,000 women undergo surgery for pelvic organ prolapse (POP) involving transvaginal placement of nonabsorbable surgical mesh that commonly results in many serious and potentially life-threatening complications. Find out why safer, equally effective non-mesh surgery is a better alternative.
Proton-Pump Inhibitors: Dangerous and Habit-Forming Heartburn Drugs
September 2011
PPIs are now one of the most widely used classes of prescription drugs, with an estimated one out of every 20 people in the developed world currently taking one of these medications. However, given that recent research shows PPIs may be habit-forming, that the majority of PPI use is probably inappropriate, with minimal or no benefit to the patient, and that new, life-threatening risks with long-term therapy are continually emerging, it is time for the medical community to re-evaluate the role of PPIs in everyday practice.
Too Much Levothyroxine Increases the Risk of Fractures in Older Adults
August 2011
Many of the millions of older adults who take thyroid pills are taking too much each day, with significantly increased risks of bone fractures. Find out what to do.
Cholesterol-Lowering Combination of Extended-Release Niacin (NIASPAN) Plus Simvastatin (ZOCOR) Misses the Mark
August 2011
NIASPAN (extended-dose niacin) alone may still be useful, but in a study published in 2011, it did not add any benefit when taken along with the statin simvastatin.
Inappropriate Prescribing of Atypical Antipsychotic Drugs in the Elderly: Inexcusable Deaths and Medicare Dollars Wasted
August 2011
Most prescriptions for antipsychotic drugs to people in nursing homes are inappropriate and quite dangerous. Find out what you can do to protect your family or friends.
Another Addition to the Annals of Prescription-Drug Price Gouging
August 2011
Find out how a generic manufacturer got an exclusive "brand name" for its previously generic gout drug, colchicine, and increased the price by 125 times.
Prescription Drugs and Increased Traffic Accident Risk
July 2011
The article reviews evidence that taking any of eight different classes of prescription drugs can significantly increase the risks of being involved in a traffic accident in which someone is injured. Find out what the classes of drugs are.
Rivastigmine (EXELON) May Be Harmful to Critically Ill Patients
July 2011
In addition to its use for Alzheimer's disease, the drug rivastigmine (EXELON) is used to treat critically ill patients with delirium in intensive care units (ICUs). In a November 2010 study, those getting the drug had a death rate almost three times higher than those getting a placebo.
Revisiting Memantine (NAMENDA) and Other Alzheimer’s Disease Drugs
July 2011
Find out what outside experts, in published medical journal articles, think about the usefulness of the currently available drugs for treating Alzheimer's disease.
Warning About SimplyThick for Premature Infants
July 2011
Find out about a life-threatening intestinal condition that can be caused by feeding premature infants infant formula or pumped breast milk treated with this thickening agent.
Remove Dangerous Alzheimer’s Drug -- ARICEPT 23 -- From the Market Immediately
July 2011
Find out why Public Citizen and an expert in Alzheimer's disease from Johns Hopkins have asked the FDA to ban the recently approved Alzheimer's drug, Aricept 23, from the market.
Correction: 'Liraglutide (VICTOZA): Add Another One to the List of "Do Not Use" Drugs for Type-2 Diabetes'
July 2011
There was an error in a paragraph describing interpretation of the results of the blood test hemoglobin A1c (HbA1c), which is used to assess the body’s control of sugar (glucose).
Dutasteride (AVODART) to Prevent Prostate Cancer
June 2011
Find out why a drug widely used to treat prostate enlargement should not be used to prevent prostate cancer.
Drug Mix-Ups
June 2011
This article lists 355 drugs with names that are often confused with similar-sounding drug names. Find out what you can do to prevent getting the wrong drug.
Foreign Corrupt Practices By the U.S. Pharmaceutical Industry
June 2011
Find out how Johnson & Johnson officials "violated the Foreign Corrupt Practices Act (FCPA) by bribing public doctors in several European countries and paying kickbacks to Iraq to illegally obtain business."
Antidepressants: Effective for Major Depression, Not for Minor Depression
May 2011
Find out the difference between major depression and minor depression and why antidepressants, which are effective with precautions for the former, are not effective for the latter.
Will Cranberry Juice Every Day Keep the Doctor Away (And Prevent Urinary Tract Infections)?
May 2011
Previous studies have shown cranberries to have some effectiveness in preventing urinary tract infections. However, in these studies the researchers and subjects knew what they were receiving, which almost always guarantees a biased result favoring the treatment. Find out what a new study, where both patients and doctors were not aware of whether they were using cranberry juice or fake cranberry juice, concluded.
Oral Contraceptives Containing Drospirenone - Increased Risk of Blood Clots
May 2011
This article reviews recent studies showing significantly increased risk of blood clots in high-selling contraceptives containing drospirenone, compared to the lower risk of blood clots with older contraceptives containing levonorgestrel. Drospirenone is an ingredient in the contraceptive pills Yaz and Yasmin, which are sold in the U.S.
What Should People Do if They Miss a Dose of Their Medicine?
May 2011
This article, adapted for U.S. patients from an excellent review of the topic in the U.K., gives answers as to what course of action to follow if you miss a dose.
Illegal Promotion of a Drug That Causes Birth Defects
May 2011
Find out why Johnson & Johnson was recently criminally prosecuted for illegally promoting an epilepsy drug that clearly causes birth defects.
Drug-Induced Acute Akathisia (Restlessness)
April 2011
The article lists 27 drugs that can cause akathisia, a condition characterized by muscular quivering and the inability to sit still. Other signs of the condition include fidgety movements, leg swinging while sitting, rocking from foot to foot or pacing and motor restlessness.
Review of Type-2 Diabetes Medication Liraglutide (VICTOZA)
April 2011
This article reviews the safety and efficacy of liraglutide (VICTOZA), a new medication used to treat type-2 diabetes.
Update on Herpes Zoster (Shingles) Vaccine: Zoster Vaccine Live (ZOSTAVAX)
April 2011
Find out what the latest study of the effectiveness of the shingles vaccine reveals.
Pharmaceutical Industry Is Biggest Defrauder of the Federal Government
April 2011
The pharmaceutical industry has now surpassed the defense industry as the largest defrauder of the federal government, as determined by payments it has made for violations of the False Claims Act (FCA).
Quality of Drug Prescribing
March 2011
The article reviews a study on the potentially dangerous, inappropriate prescribing of 77 drugs that pose a high risk to older adults. Of the 67 of these drugs that we had previously reviewed in Worst, Pills, Best Pills News, we had classified 60 (90 percent) of them as “Do Not Use,” and the other seven as "Limited Use."
No. 1 Rule for Safe Drug Use: Have ‘Brown Bag Sessions’ with Your Primary Doctor; Fill Out a Drug Worksheet
March 2011
The article details how you should review all of the medications you are using with your doctor. It also provides a drug worksheet for you to fill out with him or her. The worksheet, when shown to your doctors, may save you from being prescribed drugs that interact with each other or have other side effects that you might not have recognized as being drug-related.
‘Should the FDA Review Drugs Used for Executions?’
March 2011
We discuss the controversy about the role of the FDA in approving the use of prescription drugs used to execute prisoners.
Homeopathic Teething Tablets Recalled Due to Possible Belladonna Toxicity in Children
February 2011
This article discusses why certain homeopathic teething tablets should not be used and lists symptoms of their toxicity that parents and other child caregivers can look for.
Nine Rules for Safer Drug Use
February 2011
We discuss nine safety rules you need to know when using medications. The tenth, equally important rule will be discussed in detail in next month's issue.
Saxagliptin (ONGLYZA) - Another Diabetes Drug
February 2011
This article discusses why you should not use this newly approved diabetes drug until more is known about its safety.
Vitamins C and E and Prevention of Cataracts
February 2011
This article discusses the results of a new study involving more than 11,000 people who were given vitamin E, vitamin C, vitamin E and C together, or placebos and followed them to see if they developed new cataracts. The article also includes a review of older studies of the effects of these vitamins on colds, kidney stones, cancer, heart disease and other diseases.
Extra Dollars for Docs
February 2011
Find out how to see if your doctor is one of more than 32,000 who have taken money from pharmaceutical companies, mainly for acting as drug company speakers or as consultants. Three hundred eighty-four of these physicians have gotten more than $100,000 in little more than one year. Does this affect the way they treat you?
Update on Withdrawals of Dangerous Drugs in the U.S.
January 2011
This article lists 11 of the prescription drugs that we warned Worst Pills, Best Pills News subscribers not to use before they were banned by the FDA. Subscribers knew an average of 3.3 years before the FDA acted that these medications were unsafe to use.
FDA Consumer Warning: Dangerous Chelation Products to Treat Serious Diseases
January 2011
Learn about all of the diseases for which chelation products are illegally promoted, the products' lack of effectiveness for treating any of these diseases, and some of the products' serious risks.
Interactions Between Methotrexate (TREXALL) and Proton Pump Inhibitors (PPIs) and Many Other Drugs
January 2011
This article discusses the dangerous interactions that can occur when using methotrexate (TREXALL) with certain other drugs. See our list of 27 drugs you should never take with methotrexate.
Delayed FDA Removal of Painkiller Propoxyphene (DARVON, DARVOCET) From U.S. Market Has Cost More Than 1,000 U.S. Lives
January 2011
Learn about our efforts to ban Darvon and our warnings about the drug going back 32 years. Why did the FDA take so long to ban it compared to the United Kingdom and Europe?
Pitavastatin (LIVALO): 8th Cholesterol-Lowering Statin Marketed in the U.S.
December 2010
Find out why you should not use the newest entry into the crowded statin market.
Neuroleptic Malignant Syndrome (NMS)
December 2010
The article describes the symptoms of the life-threatening neurological disorder neuroleptic malignant syndrome (NMS) and lists 40 different prescription drugs that have been found to cause it.
Fatal Drug Interactions With Simvastatin (ZOCOR)
December 2010
Find out how simvastatin (ZOCOR) can interact with another widely used drug to greatly increase the chance of life-threatening muscle damage that can lead to kidney damage.
Erectile Dysfunction Drugs and Hearing Loss
December 2010
The article describes evidence that sudden hearing loss can occur in people using certain erectile dysfunction drugs, and tells you which drugs can cause this problem. It also describes other symptoms that can accompany the onset of this drug-induced hearing loss.
U.S. Troops: More Deaths Related to Prescription Drugs
December 2010
Two recent studies found that indiscriminate prescribing of drugs to U.S military troops has been associated with an increase in drug-associated suicides and drug-induced deaths, probably related to interactions between drugs.
Estradiol Spray (EVAMIST) for Hot Flashes — Risks for Children and Pets
November 2010
This article discusses the potential risks to children and pets when they come in contact with the skin of someone who has used estrogen sprays for hot flashes.
Corticosteroid Drug Interactions
November 2010
This article discusses 36 drugs that, when used by people also using a corticosteroid, can either cause toxic interactions with the steroid or decrease the steroid's effectiveness.
Lamotrigine (LAMICTAL): Risk of Aseptic Meningitis
November 2010
Non-bacterial (aseptic) meningitis has been found in some people using the anti-convulsant drug lamotrigine (LAMICTAL), which is also used to treat bipolar illness. This article explains the symptoms of meningitis, what to do if these symptoms occur and how to prevent drug-induced meningitis.
Adverse Drug Reactions: How Serious Is the Problem and How Often and Why Does It Occur?
November 2010
Find out how many deaths, hospitalizations and emergency room visits are caused by adverse drug reactions, many of which could have been prevented.
Drug-Induced Parkinsonism
October 2010
A study discovered that more than 1 out of every 10 people who went to a Parkinson’s disease center was found to have drug-induced Parkinsonism. These people were misdiagnosed as having the more common illness, Parkinson’s disease, which is irreversible and has unknown causes.
Lipodissolve Products for Weight Loss
October 2010
The lipodissolve procedure involves a series of injections that purport to selectively melt away pockets of fat in the body. On April 7, 2010, the Food and Drug Administration (FDA) issued warning letters to companies selling lipodissolve products and alerted consumers about the products’ risks.
Bupropion Drug Interactions
October 2010
Bupropion is used to treat depression (brand name: WELLBUTRIN) and to aid smoking cessation (brand name: ZYBAN). The drug has a number of potentially dangerous interactions, some of which are quite different from typical antidepressant interactions.
Stronger Liver Toxicity Warning for the Arthritis Drug Leflunomide (ARAVA)
October 2010
On July 13, 2010, the Food and Drug Administration (FDA) announced that the black-box warning for the arthritis drug leflunomide (ARAVA) will be updated to highlight the risk of severe liver injury with the use of this drug and to explain how this risk may be reduced.
The Dangers of Combining Sleeping Pills With Other Medication
September 2010
The article list 34 other medications that can harmfully interact with sleeping pills, increasing their sedative properties and causing excessive sedation. Excessive sedation at night could increase the risk of falls, should the person get up in the night for some reason. Moreover, excessive sedation causing respiratory depression could be dangerous for people with certain disorders, such as lung disease.
Risk of Overdose — Rivastigmine Transdermal (Exelon) Patch for Alzheimer’s Disease
September 2010
Yet another problem has arisen with this drug which we have listed as DO NOT USE for a long time. There are a growing number of people who have unintentionally overdosed with the EXELON patch, leading to symptoms of toxicity described in the article. We also discuss ways of avoiding this dangerous overdose.
Life-Threatening Side Effects With Quinine (QUALAQUIN)
September 2010
Quinine is only approved to treat malaria but most of the use is for treating or preventing nighttime leg cramps, a purpose for which there is no evidence of effectiveness. Among 38 reports of serious side effects, including two deaths and two dozen cases of serious blood reactions, almost all occurred in people using the drug for purposes other than malaria.
French Court Dismisses AstraZeneca Complaint Against French Health Insurer Regarding CRESTOR
September 2010
Another blow for Crestor occurred when a French court upheld the right of health insurers to state that the drug does not provide any significant added benefit compared to other medicines and recommended that doctors should only prescribe it in serious cases.
Beware: Bioidentical Hormones
September 2010
Many women are using so-called bioidentical hormones, "natural" and implicitly safer versions of prescription drugs such as Premarin, because the latter drugs have been found to cause breast cancer, heart disease and many other serious health problems. The article discusses the fact that these products can be expected to have the same serious adverse effects that con­ventional preparations have and that they have the added disadvantage of not being regulated and thereby having unpredictable amounts of ingredients.
New Iloperidone (FANAPT) Is Not as Effective as Older Drugs For Schizophrenia Treatment
August 2010
The article explains why you should not use the new drug for schizophrenia, FANAPT.
Possible Increased Risk of Fractures With Long-Term, High-Dose Use of Heartburn Drugs
August 2010
The article reviews evidence that patients 50 years old or older who take proton pump inhibitors (PPIs -- a list of the six approved ones is in the article) or use them for a year or more may be at increased risk of fractures of the hip, wrist and spine. Since much of the use of these drugs is inappropriate and unnecessarily dangerous, the article discusses pharmacologic and non-pharmacologic alternatives to PPIs.
Vitamins and Minerals: A User’s Guide
August 2010
Vitamin and mineral supplements are a booming business in this coun­try. Many people are misled by ad­vertising into thinking that taking a supplement will help get rid of many of their health problems. But this is not the case.
Interactions With Cancer Drug Vincristine (ONCOVIN)
August 2010
The article lists 34 prescription drugs that can have harmful interactions with vincristine. Recognizing signs of toxicity from vincristine early, as described in the article, is urgent because most of the side effects are reversible when the interacting drug is stopped and the patient receives corrective treatment.
Zolpidem (AMBIEN) Reinvented As Zolpidem Sublingual (EDLUAR) For Sleep
July 2010
Learn more about zolpidem sublingual tablets (EDLUAR), a newly approved drug for the short-term treat­ment of difficulty falling asleep.
Dexlansoprazole (KAPIDEX, DEXILANT): The Sixth Proton Pump Inhibitor for Heartburn
July 2010
This sixth drug for treating "heartburn" has no advantage for patients over older drugs such as PREVACID, generic name lansoprazole. Any advantage is for the industry because the manufacturer of DEXILANT charges three times more for this drug than the cost of generic lansoprazole, sold by another company and just as effective for patients.
Preserving Bones with Bisphosphonates: Should You Avoid NSAIDs?
July 2010
It appears likely that patients who take bisphosphonates (such as FOSAMAX) and NSAIDs at the same time have an increased risk of gastrointestinal ulcers as opposed to taking either drug alone. The article reviews the studies demonstrating this and offers some practical advice on what the cautious drug user should do.
Severe Liver Toxicity Added to Already Lengthy List of Risks for Diet Drug Orlistat (XENICAL, ALLI)
July 2010
New evidence of severe liver failure, sometimes fatal, caused by orlistat (over-the-counter as ALLI, prescription version, XENICAL) adds to the many other reasons why no one should use this drug. They include Do not use orlistat. This drug has a meager effect on weight, but its potential to cause serious side effects, including pre-cancerous lesions of the colon (aberrant crypt foci), liver damage and pancreatitis, is significant. The most common side effects of orlistat include oily spotting, gas with discharge, fecal urgency, fatty/oily stools and fre­quent bowel movements. The article lists symptoms of liver failure.
Alternatives for Sleeping Problems
July 2010
Experts in sleep and aging have stated, “It’s extraordinarily rare to find an old person who actually requires sleeping pills." This article lists many over-the-counter and prescription drugs that can actually cause difficulty with sleeping and also discusses a variety of non-pharmacologic alternatives to sleeping pills. Sleep experts have also said that “Nonpharmacological treat­ments not only cause fewer side ef­fects, but they can sustain long-term improvements more successfully than pharmacological treatments.”
Should Vitamins Be Regulated As Drugs?
June 2010
Increasing knowledge about the risks and, in some cases, lack of benefits of vitamins suggests that by classifying vitamins as drugs, companies would be forced to give patients much more information than they now provide and would have to back medical claims for efficacy and safety with evidence. The article also provides recent evidence of previously unknown harms from certain vitamins and updates on current knowledge about the 13 most commonly used vitamins.
Dextromethorphan (DELSYM, ROBITUSSIN DM) for Cough: More Reasons to Avoid It
June 2010
Find out why you should not use cough products such as ROBITUSSIN DM that contain dextromethorphan. Also view a list of 22 other drugs that can have harmful interactions with dextromethorphan.
Safety Update for Transplant Drugs Mycophenolate (CELLCEPT) and Mycophenolic Acid (MYFORTIC)
June 2010
For these drugs, approved only for people who have had organ transplants, there are more than one million prescriptions a year filled at a cost of more than $700 million dollars. There is clearly some prescribing for medical conditions for which the drugs are not approved. This has serious implications since the drugs can cause several kinds of life-threatening toxicity, described in the article.
Oral Drugs for Diabetes: Avoiding Hypoglycemia
May 2010
After explaining the symptoms of low blood sugar (hypoglycemia) the article lists 42 prescription drugs that can interact with one or more diabetes drugs to increase the chance of hypoglycemia.
Smoke & Mirror Marketing (& Other Clever Big Pharma Tricks)
May 2010
The article reviews 12 prescription drugs, many of which are top-sellers, all of which are greatly overpriced in comparison to older "versions" of the same drugs. The patents on the old drugs expired so the "innovative" companies patented these new products, gaining a patent on them, and, for all practical purposes, using them as a license to print money. There is no evidence that any of the new ones are better than the now less-expensive, old versions.
Safety Concerns Lead to Label Changes For Topical Testosterone
May 2010
The article reviews the dangers of testosterone gels and gives recommendations that adults who use testosterone gels should follow.
Drugs for Cold Sores: How Well Do They Work?
May 2010
The article reviews studies showing that widely-sold prescription drugs for treating cold sores, such as ZOVIRAX, DENAVIR, FAMVIR, and VALTREX and ABREVA have significant side effects, are expensive and, on the average, only reduce the duration of the cold sore by less than one day. The article describes other non-drug methods to treat cold sores that make more sense.
Risk of Serious Gastrointestinal Bleeding With Newer Antidepressant Drugs
April 2010
This article discusses the greatly increased risk of bleeding with some widely-used antidepressant drugs and provides information that the FDA has not yet required be included in the patient Medication Guides for these drugs.
Aripiprazole (ABILIFY) Drug Interactions
April 2010
The article lists 53 drugs that can interact with the psychiatric drug ABILIFY to either increase the amount in the body, which can lead to toxicity, or decrease the amount rendering the drug less effective.
Reporting Adverse Events from Drugs and Medical Devices to the Food and Drug Administration
April 2010
Learn how to report dangerous side effects of drugs and dietary supplements to the Food and Drug Administration (FDA).
Digoxin Drug Interactions
March 2010
The article lists 35 different interacting drugs that can either increase blood levels of digoxin, leading to the serious problem of digitalis toxicity or decrease blood levels, causing the drug to be less effective.
A New Old Drug for Depression: Desvenlafaxine (PRISTIQ)
March 2010
Find out how Pristiq and the older antidepressant drug, Effexor are, essentially, the same and why not to use the new one.
Liver Toxicity With Topical Diclofenac Sodium (VOLTAREN)
March 2010
Although skin application of drugs usually results in lower blood levels than oral use, cases of liver toxicity have been found with topical diclofenac Sodium (VOLTAREN). The article lists other names of these products and explains the warning signals that may indicate liver toxicity.
Europe Moves to Ban Sibutramine (MERIDIA): FDA Should Ban Weight-Loss Drug
March 2010
In the first study to examine the long-terms consequences of using any diet drug, sibutramine (MERIDIA) actually increased the risk of stroke, heart attack, resuscitated cardiac arrest or cardiovascular death in patients taking the drug, compared to those taking a placebo. The results of this study properly caused European drug agency to recommend banning the drug. In this country, the FDA recklessly decided to leave it on the market for now.
Quetiapine (SEROQUEL) Interactions With Other Drugs
February 2010
Quetiapine (SEROQUEL) can interact with 26 different drugs, increasing its blood levels and causing dangerous side effects such as slowed breathing, dizziness and fainting. The article also lists 10 other interacting drugs that can result in lower blood levels, rendering the drug less effective.
A Review of Drugs for Overactive Bladder
February 2010
The newest FDA-approved drug for treating overactive bladder, TOVIAX (fesoterodine) is no more effective than the older five drugs, reducing the number of urinations a day by only one. In addition, since it is a new drug, we recommend not using it now because more will be known about its dangers after it has been on the market for a longer time.
Black Box Warnings Updated on Tumor Necrosis Factor Blockers
February 2010
New warnings are being required on CIMZIA, ENBREL, HUMIRA, EMICADE and SIMPONI because of evidence that lymphoma (tumor of lymph tissue) and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers.
Type 2 Diabetes Drugs Fail to Improve the Most Serious Long-Term Complications
February 2010
The article discusses why all of these 16 diabetes drugs carry a label stating: "There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction [heart attacks, strokes, etc] with oral antidiabetic drug[s]." The article also explains why lifestlyle changes such as diet and exercise to prevent or even treat type II diabetes are not heavily promoted or usually reimbursed.
New Black Box Touts Old Warning: Drug-Induced Movement Disorders with Metoclopramide (REGLAN)
January 2010
The FDA has belatedly required a black box warning that treatment with metoclopramide (a drug for heartburn unresponsive to conventional therapy and for the symptoms of gastroparesis, a condition in which the stomach takes too long to empty its contents) can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. We have warned Worst Pills readers about this for 21 years.
A Review of ADHD Drug Lisdexamfetamine (VYVANSE)
January 2010
We list this amphetamine-like drug as DO NOT USE because it is more expensive than (and does not treat ADHD better than) older, safer alternatives (such as methylphenidate [RITALIN]).
Lithium Toxicity Due to Drug Interactions
January 2010
This article lists a large number of drugs, used to treat high blood pressure and other carediovascular disease, that can interact harmfully with lithium (ESKALITH; LITHOBID; LITHONATE;generic lithium carbonate), drugs used to treat bipolar (manic/depressive) disorder. This may result in a dangerous condition known as lithium toxicity because these drugs stop the body from getting rid of lithium and lithium blood levels are increased; in severe cases, this can cause seizures, coma and even death. The article also lists other symptoms of lithium toxicity.
Think Twice About Third-Generation Oral Contraceptives and YASMIN
December 2009
Two large new studies shed light on the increased risks of so-called "third generation" oral contraceptives containing desogestrel as well as oral contraceptives containing drospirenone (such as YASMIN and YAZ) compared to older, "second-generation" oral contraceptives. This study also discusses newly discovered risks associated with YASMIN and YAZ.
The Myth Is False: Caffeine Will Not Sober You Up After Drinking Alcoholic Beverages
December 2009
Many people believe that drinking caffeine with or after drinking alcohol will sober them up, but there is no evidence to support this.
An Update on H1N1 Influenza
December 2009
As the H1N1 influenza continues to spread, we review the best ways to prevent the flu. We also discuss over 100 products that the Food and Drug Administration reprimanded for selling unapproved flu treatments online.
Supreme Court Justice Ginsburg’s Drug Interaction Is a Reminder to Pay Attention to Meds
December 2009
In mid-October, Supreme Court Justice Ruth Bader Ginsburg was kept at a hospital overnight after she became drowsy, fell from her airplane seat and had to be taken off the plane before it departed. What common drug interaction was to blame?
The Case of Neurontin: Skewed Research in the Service of Selling
December 2009
When pharmaceuticals are intent on proving that one of their products is safe and effective, they may engage in practices that are professionally suspect and morally unethical. The recent news on Neurontin is a case in point.
A Review of Exenatide (BYETTA) for Type-2 Diabetes
November 2009
Because exenatide (BYETTA) is a new drug with increasing reports of severe, hospitalization-requiring pancreatitis and offers no significant breakthrough compared to other diabetes drugs, we urge readers not to use it until 2012--seven years after its approval, by which time much more will be known about its dangers.
Middle Ear Infections and Antibiotic Use in Children
November 2009
The article explaions how parents, in consultation with their doctors, in certain circumstances can safely avoid using antibiotics for treating children's middle ear infections.
New Gout Drug Febuxostat (ULORIC) Has Important Drug Interactions: Do Not Use Until 2016
November 2009
The article explains why febuxostat (ULORIC) should not be used because of problems with both its safety and effectivness.
An Update on the HPV Vaccine GARDASIL
November 2009
The article updates our previous information on the benefits and risks of this important vaccine.
Antacid Drug Interactions
October 2009
Antacids can interact with a number of medications, either increasing or decreasing drug effect.
A Review of Homeopathy
October 2009
This article reviews how homeopathy is said to work and concludes that there is no condition for which its effectiveness has been convincingly demonstrated.
Insulin Glargine (LANTUS) and Cancer: Is There a Link?
October 2009
We review recent studies potentially implicating one form of insulin in cancer and conclude that there is insufficient evidence to link the drug to cancer at present.
Are We Now Twice as Sad? The Drug Industry and Doctors Think We Are!
October 2009
The use of anti-depressants in the U.S. nearly doubled in a 10-year period as drugs displaced "talk therapy" and the drugs came to be used for an ever-widening set of disorders.
Milnacipran (SAVELLA) Fails to Alleviate Fibromyalgia Pain, Has Safety Concerns
September 2009
This article raises serious questions about the the limited effectiveness of SAVELLA and reviews evidence of serious toxicity.
Oxycodone: Be Careful What You Take With It
September 2009
The article lists 24 drugs that can increase the toxicity of oxycodone if taken together with the drug and 11 other drugs that can weaken its effectiveness as a painkiller if they are simutaneously used.
A Review of Shingles Vaccine ZOSTAVAX
September 2009
The article reviews the benefits and risks of the new shingles vaccine and discusses who should and who should not get the vaccine.
Facts and Myths about Generic Drugs
September 2009
Common myths, often spread via the brand name drug companies who lose as a result of competition from lower-priced generic drugs, are discussed and rebutted in this article.
Ghostly Prescriptions
September 2009
The article describes how many noted physicians lent their name to articles they had not actually written resulting in much more prescribing of hormones to post-menopausal women. As a result, this misinformation caused thousands of cases of breast cancer and heart disease. Some doctors received medical school tenure on the basis of their "literary production" when they had merely agreed to stake their names (and, by extension, the reputations of their institutions) to enhance pharmaceutical company's profits and line their own pockets.
New Study Further Links Alzheimer's Drugs to Side Effects
August 2009
We review evidence from a recently-published medical journal article that syncope (fainting), often leading to falls, can be a serious side effect of the Alzheimer’s disease drugs donepezil (ARICEPT), rivastigmine (EXELON) and galantamine (REMINYL). In addition, hospitalizations for slow heart rhythms, pacemaker insertions and hip fractures — all of which can be related to syncope — increased in patients using these Alzheimer’s drugs. This, along with their questionable effectiveness, further increases the evidence underlying our recommendation not to use these drugs.
Do Automated Screening Systems for Drug Interactions Adequately Protect You?
August 2009
Many doctors and pharmacists use computerized drug interaction screening systems to prevent the prescriptions for drugs that may have a harmful interaction with drugs already being used by the patient. This article points out several significant weaknesses of these systems and provides five common sense suggestions as to how patients can avoid dangerous drug interactions despite the weaknesses of these computerized systems.
Herbal Medicines for Menopausal Symptoms? Hang Onto Your Wallet and Your Health
August 2009
The article reviews published evidence of safety and effectiveness for five herbal supplements widely used for treating menopausal symptoms. There is no convincing evidence that any of the herbal supplements promoted for relief of menopausal symptoms is beneficial. In addition, as discussed in the article, many of them have serious safety problems.
FDA Requires Warnings about Serious Mental and other Side Effects With Certain Asthma Drugs
August 2009
The FDA has just warned about about mood and behavior changes for three drugs used to treat asthma: montelukast (SINGULAIR), zafirlukast (ACCOLATE) and zileuton (ZYFLO, ZYFLO CR). The article describes these side effects and urges that patients talk with their health care providers if these events occur. However, we advise that patients should not stop any asthma medication without first consulting your physician. Abruptly stopping a medication may result in acutely deteriorating asthma control.
How Ineffectual Medical Treatments Can Misleadingly Produce “Good” Results
August 2009
Many drugs, devices, and procedures that are found to be ineffectual or even dangerous have seemed to work when initially introduced, or seemed to prove useful for selected populations. Consumers are therefore often puzzled when some therapies that are initially hailed as breakthroughs are later pronounced useless, even hazardous.
No More Free Drug Samples?
July 2009
The article discusses a variety of reasons why it is neither in the best interests of doctors to prescribe or patients to use free samples. The truism that "there is no such thing as a free lunch" rings true once again.
Another Chapter in the Long History of Exposing the Dangers of the Most Popular Drug in America
July 2009
This article documents how long it has taken the FDA to fully implement a recommendation from its own advisory committee 32 years ago stating that: "Do not exceed the recommended dosage [acetaminophen--as in Tylenol] because severe liver damage may occur." Other countries have done more.
Muscle Damage from Interactions Between Statins and Other Commonly Prescribed Drugs
July 2009
The article lists 38 prescription drugs that can harmfully interact with statin drugs. The article also advises that No matter what statin you are taking and regardless of any interacting drugs, you should notify your prescriber immediately if you develop muscle pain, weakness or a darkening of your urine. .
A Review of Lubiprostone (AMITIZA) for Irritable Bowel Syndrome with Constipation
June 2009
Do not use lubiprostone. There are safer and equally or more effective treatments for both chronic constipation and for the constipation variety of irritable bowel syndrome. We have just asked the FDA to place a black box warning on this drug because it may cause abortions in women using it who are pregnant.
Hypothyroidism: A Consumer’s Guide to Diagnosing and Treatment
June 2009
The article explains why it is not a good idea to start treatment with thyroid hormone replacement without confirmation with laboratory tests that you actually have hypothyroidism. It also discusses the kinds of symptoms that should lead you to have your thyroid level checked.
The BOTOX Label Gets Ready for its Close-up
June 2009
Sixteen months after we petitioned the FDA to greatly increase warnings to doctors and patients about BOTOX, the agency has agreed to do so. The article discusses some of the life-threatening side effects of the drug such as swallowing and breathing problems and points out that much of its use is for conditions for which it has not been approved by the FDA.
Alpha-Blockers for Prostate Enlargement: Some Important Drug Interactions
June 2009
Taking alpha-blockers in combination with drugs for erectile dysfunction and with other drugs can cause dizziness and fainting. In this article we will discuss alfuzosin (UROXATRAL), doxazosin (CARDURA), tamsulosin (FLOMAX) and terazosin (HYTRIN) and drugs with which they can have harmful interactions.
Vermont’s Pharmaceutical Laws Move Toward Fuller Disclosure
June 2009
A new Vermont law is the most extensive state law requiring the reporting of payments from drug and device companies to physicians.
What is Comparative Effectiveness Research, and Why is it Being Badmouthed?
June 2009
Comparative effectiveness research permits comparisons between existing therapies to establish whether they are safer or more effective than one another. The pharmaceutical industry opposes these studies because it doesn't want you to know the truth about these therapies.
People on Certain Beta Blockers Should Be Wary of Epinephrine
May 2009
Patients taking a non-selective beta blocker should make sure the provider is aware of this before they receive an injection of epinephrine, as your physician or other health care provider may not be aware that a systemic dose of epinephrine may produce a dangerous spike in blood pressure. The article lists the selective beta blockers that do not cause this problem because they do not interact with epinephrine.
What Aspirin Dose Is Safest and Most Effective for Preventing Heart Disease?
May 2009
This article discusses the fairly narrow range of daily aspirin doses most safe and effective for preventing heart disease.
Weight-Loss Supplements Illegally Spiked with Prescription Drugs
May 2009
The article lists 72 weight loss dietary supplements that have recently been found to have been spiked with one of nine different prescription drugs, often at dangerously high concentrations. If you have used any products containing these ingredients, you should stop taking them and consult your health care professional immediately.
WARNING: MRI Scans May Burn Patients Wearing Transdermal Drug Patches
May 2009
On March 5, 2009, the FDA sent a public health warning to patients and doctors that transdermal drug patches containing metal may overheat during a MRI scan, causing skin burns. The article discusses several precautions you can take to prevent this from happening.
Possible Interaction Between Cranberry Products and Widely Used Blood-Thinner Warfarin (COUMADIN)
April 2009
This article adds other substances, cranberry products, to the long lists of drugs we have previously stated should not be used with the important blood thinner, warfarin (COUMADIN).
LOVAZA: Limited Use Drug for Lowering Trigylcerides
April 2009
The article reviews a widely-prescribed drug that contains a specific formulation of purified fish oil that is only approved for lowering very high levels of one type of fat, triglycerides, because these high levels can increase the risk of pancreatitis. The article explains why there should only be limited use of this drug.
Drug-induced Cognitive Impairment: Part 2: Delirium and Dementia
April 2009
This second article about drug-induced dementia or delirium lists and discusses an additional 79 drugs that can cause these reversible kinds of mental deterioration. The two articles collectively review 136 drugs that can cause these serious side effects, especially in older people.
Watch Out for Interactions with Tamoxifen (NOLVADEX)
March 2009
Tamoxifen (NOLVADEX) is still widely and successfully used for treatment of breast cancer. However, when used along with certain other drugs, its effectiveness can be significantly reduced. The article explains how this can happen and lists 19 different drugs that can cause this serious problem if used with tamoxifen.
Drug-Induced Cognitive Impairment: Part One
March 2009
The article lists 57 different drugs that can cause dementia if used. This can be even more problematic if more than one of these drugs is being taken. These drugs are only one class of drugs that can cause mental deterioration and next month's issue will discuss additional drugs that can also impair thinking.
Dangerous Interaction Between Heartburn Drugs and Clopidogrel (PLAVIX)
March 2009
This article describes how and why people using both PLAVIX, a drug that prevents blood clotting, and heartburn drugs such as NEXIUM had a 27 percent increased risk of heart attacks compared with people using PLAVIX alone.
Update: Oral Sodium Phosphate Used as Preparation for Colonoscopy Can Cause Kidney Damage
March 2009
The article explains how certain commonly-used prescription and over-the-counter drugs can cause kidney damage when used as bowel preparation for colonoscopy. The article also list alternative drugs for this important screening procedure that do not cause kidney damage.
Nonsteroidal Anti-Inflammatory Drugs Can Make Blood Pressure Hard to Control
February 2009
Twenty different NSAIDS (nonsteroidal antiinflammatory drugs) are listed in this article that can adversely affect your blood pressure control. The article discusses the way in which this happens and what you can do about it.
New Study: Vitamin C and Vitamin E Do Not Prevent Cancer
February 2009
The article discusses evidence from a large, new study finding that neither Vitamin C nor E had an effect on prostate cancer, a number of other cancers total cancer. The article also reviews older evidence concerning the effects of these vitamins on cardiovascular disease and other diseases.
Reporting Side Effects from Drugs and Medical Devices to the Food and Drug Administration
February 2009
The sooner the Food and Drug Administration (FDA) finds out about serious side effects of drugs, the more quickly it can warn the public. The article explains you can easily report suspected side effects of drugs or other medical products to the FDA.
“Morning after” Contraception: Too Difficult to Get
February 2009
Despite a 2006 Food and Drug Administration decision to make the morning-after contraceptive Plan B over the counter, 31% of pharmacies in Los Angeles do not carry the product.
Watch out for Interactions Between Drugs for Erectile Dysfunction and Other Medications
January 2009
The article lists 56 drugs that can interact with the three drugs for erectile dysfunction (ED): sildenafil (VIAGRA), tadalafil (CIALIS) and vardenafil (LEVITRA). Eight of the drugs are either nitrates such as nitroglycerin or a certain group of high blood pressure drugs.In combination with ED drugs, these drugs can cause a dangerous fall in blood pressure that could lead to a heart attack or stroke. Thirty-two other drugs can inhibit the enzyme that helps the body to eliminate the ED drugs, resulting in abnormally high blood levels of the drugs and a potentially harmful "overdose" even though you are actually taking the recommended amount. The other 16 drugs speed up the metabolism of the ED drugs, thereby lowering the blood levels and reducing the effectiveness of the ED drugs.
Prescribing “Easy Fix” Placebo is Common
January 2009
In a recent survey of U.S. doctors, 55 percent of those responding stated that, in the past year, they had used a placebo, defined as “a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself.” However, the prescribing of these "placebos" was not limited to the traditional inert "sugar pill" but also included actual drugs such as over-the-counter analgesics,sedatives and antibiotics, products that can have serious side effects even though, for the illnesses they were being used to treat, they would not be expected to have benefits beyond the patient expectation level. The article concludes with a discussion of the basis of our opposition to the use of placebos.
Long-term Use of Bisphosphonates for Osteoporosis
January 2009
Emerging reports of a rare but unique type of fracture in patients receiving bisphosphonates for many years point toward the drug as a possible culprit. Unlike most drugs, bisphosphonates remain in your body for many years after you stop taking them. Further investigation into the risks, as well as benefits, of long-term bisphosphonate use is needed. But, because there is little evidence of benefit after five years and the long-term risks remain largely unknown, it is reasonable to discuss with your doctor discontinuing these drugs after five years. However, you should continue to take calcium and vitamin D supplements at currently suggested doses (discussed in the article) regardless of whether or not you are on bisphosphonates.
Public Citizen Urges Immediate Ban of Rosiglitazone (AVANDIA)
December 2008
On Oct. 30, Public Citizen formally petitioned the Food and Drug Administration (FDA) to immediately ban the dangerous diabetes drug rosiglitazone (AVANDIA) because the drug causes multiple types of serious toxicity.
Osteoporosis Fracture Prevention: What You Need to Know about Drugs and other Measures - Part 2
December 2008
The article discusses the difference between the benefits of drugs to prevent a first fracture (primary prevention) and to prevent further fractures in people who have already experienced a fracture (secondary prevention).In addition to discussing when it may or may not be appropriate to use drugs such as Fosamax (alendronate) or Actonel (risedronate) the article discusses ways of preventing falls and other non-pharmacologic approaches to preventing fractures.
Colchicine Interactions with Other Drugs Can Be Life-Threatening
December 2008
This article lists 27 drugs that can have life-threatening interactions with the widely-used gout drug, colchicine, resulting in dangerously elevated levels of colchicine. Too much colchicine in the body leads to toxicity such as fever, vomiting, diarrhea, abdominal pain and muscle pains. Even worse, it can impair the bone marrow’s ability to make red and white blood cells, causing severe anemia and dangerously low numbers of white blood cells. When the number of white blood cells is reduced, your body may have difficulty fighting infections. Most people who have died from colchicine toxicity have had bone marrow toxicity or had preexisting kidney problems. Every patient on colchicine — whether on other drugs or not — should be alert for evidence of colchicine toxicity as described above.
Update on Drugs that Can Cause High Blood Potassium
December 2008
This article lists 68 drugs that can cause high blood potassium (hyperkalemia) that can result in nausea, fatigue, muscle weakness or tingling sensations, as well as heart abnormalities (showing up as an abnormal electrocardiogram). In some cases it can be fatal. If you are taking any of these drugs, be especially careful if you have diabetes or kidney disease. If so, you are at increased risk, and your doctor will have to weigh the risk of giving you these drugs. Also, the older you are, the more likely you are to develop hyperkalemia. Also, make sure you are receiving appropriate laboratory monitoring.
Potassium Increases Due to Drug Interactions Can Be Dangerous
November 2008
One of the most common drug interactions occurs when patients take two or more drugs that can each increase blood potassium levels. The resulting condition, hyperkalemia (increased blood potassium levels), can cause nausea, fatigue, muscle weakness or tingling sensations, as well as heart abnormalities, showing up as an abnormal electrocardiogram. In some cases it can be fatal. The article lists 50 drugs which, especially when used in combination, can cause hyperkalemia.
Muscle Injury From Use of Simvastatin (ZOCOR) with Amiodarone (CORDARONE)
November 2008
Despite the dangers of this combination--risk of severe muscle injury, rhabdomyolysis, which can lead to kidney failure or death--many clinicians continue to prescribe them together and cases of life-threatening adverse reactions from continue to be reported to the FDA. Patients taking simvastatin at a dose greater than 20 milligrams a day in combination with amiodarone should let their physician know that this combination puts them at high risk of muscle injury. There are other statins that do not appear to interact with amiodarone that are discussed.
New Evidence of Suicidal Thinking and Behavior In Patients Using Anti-Epileptic Drugs
November 2008
Among patients taking antiepileptic drugs for epilepsy, the risk of suicidal thinking and behavior was 3.5 times greater compared to placebo. These drugs are also used to treat pain and as mood stabilizers in people with manic-depressive disorders. Pay attention to common warning signs that may indicate an increased risk of suicide, including: talking or thinking about hurting oneself or ending one’s life; withdrawal from family and friends; worsening depression; increased preoccupation with death and dying; giving away prized possessions. Do not make any medication regimen changes without consulting your provider. Unsupervised sudden changes in prescription drugs can have dangerous adverse effects
Osteoporosis Screening: What You Need to Know
November 2008
The article lists 13 risk factors for fractures. But it points out that in deciding whether to use drugs, several important risk factors other than bone mineral density are often omitted which can result in inappropriate drug treatment for people who may not necessarily need it. Examples are given of patients who are really at low risk of a fracture but who often get treated.
Mongering Diseases to Hawk Pills: The Case of Fibromyalgia
November 2008
Dr. Nortin Hadler discusses the causes of and solutions to fibromyalgia.
Botox, Mark Spitz, Nadia Comaneci vs. Willie Nelson
October 2008
The article reviews what former Olympians — swimmer Mark Spitz and gymnast Nadia Comaneci - have in common with Botox. Instead of tens of millions of people watching these athletes’ performances in the past as they strived for their personal best, people will now be able to watch videos of doctors’ performances as they inject Mark Spitz and Nadia Comaneci with BOTOX. Read about the new definition of "personal best".
Tizanidine: Watch Out for Drugs Interacting With This Muscle Relaxant
October 2008
Tizanidine (ZANAFLEX) is a muscle relaxant for which more than 3.8 million prescriptions were filled in the U.S. last year. The article lists more than 64 drugs with which it can have dangerous interactions resulting in excess sedation, difficulty breathing or dangerously low blood pressure that can result in falling.
FDA Must Warn Patients Taking Fluoroquinolone Antibiotics of Possible Tendon Ruptures
October 2008
After a petition and lawsuit by Public Citizen's Health Research Group, the FDA announced in July that it will require a “black box” warning concerning tendon rupture and tendinitis caused by fluoroquinolone antibiotics, as well as an FDA-approved medication guide to be dispensed when prescriptions are filled. Although this accomplishes two of the three steps Public Citizen has urged the agency to take for nearly two years, we are troubled that the FDA is not doing everything within its power to prevent more people from needlessly suffering disabling tendon ruptures. Nothing could be simpler and more effective than a letter to doctors in addition to what the FDA has already agreed to do.
Worst Pills, Best Pills Review: Carisoprodol (SOMA, SOMA COMPOUND)
October 2008
The European Medicines Agency (EMEA) has recently proposed removing the widely prescribed, dangerous muscle relaxant carisoprodol (SOMA, SOMA COM- POUND and SOMA COMPOUND with CODEINE) from the market in all European Union countries because “the risks of these medicines outweigh their benefits.”
Massive Misprescribing of Inappropriate Drugs to Hospitalized Elderly Patients
September 2008
A nationwide study published in spring 2008 in the Journal of Hospital Medicine showed that nearly half (49 percent) of almost 500,000 hospital patients older than 65 have been prescribed one or more of 92 drugs known to be unnecessarily unsafe for older patients. 10,000 of these patients had four or more of these inappropriate medicines prescribed during their hospitalization. Among the most common categories of adverse drug reactions these inappropriately prescribed drugs can cause are excessive sedation, abnormally low blood pressure and bleeding. We list the 92 drugs in the article and give further details about the kinds of side effects these drugs can cause.
29 Medications That May Cause Adverse Interactions with Thyroid Drugs
September 2008
Thyroid medications are among the most widely-prescribed drugs in the U.S. In this article, we review 29 different medications that can have harmful interactions with thyroid medicines such as levothyroxine (Synthroid). There are four major kinds of interaction problems that can occur: • Certain medications can decrease the absorption of levothyroxine resulting in lower levels in the blood. • Other medications can increase the rate at which the body gets rid of levothyroxine, also resulting in lower thyroid levels in the blood. • Other medications can cause changes of levothyroxine binding in blood, decreasing the body's ability to use levothyroxine. • Levothyroxine can affect the safety or effectiveness of other medications by raising or lowering the levels of these other drugs in the blood, causing them to be either infective (lower levels) or dangerous (higher levels).
Athletic Prowess and the Doping of Consumers
September 2008
Athletes once were rewarded for their prowess by appearing on a box of Wheaties, but now promote drugs in frequently played commercials during the Olympics.
Advice for Patients: New Inhaler Propellants to Replace CFC Inhalers
August 2008
With the imminent demise of CFC-propelled albuterol asthma inhalers and the substitution of HFA (hydroflouroalkane)as a more environmentally-friendly propellant, two sets of problems arise. First, and the main subject of this article, are differences between the old and new propellants that require special attention by asthmatics using the new HFA asthma inhalers because they may clog more easily than the older CFC-containing ones. The second problem is cost in that less expensive generic versions of the HFA inhalers will not be available until 2010 and the half-as-expensive generic CFC albuterol inhalers will not be manufactured or sold after December 31, 2008.
Dangers of Mixing Alcohol with Certain Medications or Diseases
August 2008
The article discusses 273 drugs that can have harmful interactions with alcohol. Also reviewed are several ways in which these harmful interactions can occur: 1/ Medications Can Increase Alcohol Blood Levels 2/ Additive effects of medications and alcohol. One of the best- known drug-alcohol interactions is when alcohol, a depressant, is taken with other sedative medications, and excessive sedation or depression of respiration can occur 3/Alcohol can increase the blood levels of some medications leading to toxicity of these drugs. 4/ Alcohol also can reduce blood levels of some medications causing them to be less effective. Although some of the interactions between alcohol and medications mainly occur in people who drink heavily (three or more drinks on one occasion), many of these interactions may occur with much lower amounts of alcohol use, such as one to two drinks on an occasion. We strongly urge you to tell your physicians and other health care providers how much alcohol you are drinking so they can effectively assess the risks and advise you about the safe use of alcohol and medications.
The Growth Hormone Craze: Why it Should Be Used only Rarely
August 2008
Growth hormone is only approved for three relatively rare conditions in adults: AIDS Wasting Syndrome, Short bowel syndrome involving malabsorption of food and Growth Hormone Deficiency. Experts in the care of patients with hGH-related problems clearly state that giving hGH for antiaging, age management or bodybuilding is not medically appropriate particularly when weighing the potential benefits and risks. The article discusses known risks including soft tissue swelling, joint pains, carpal tunnel-like syndrome, breast enlargement and diabetes. Other side effects include liver and heart enlargement, increased pressure around the brain and high blood pressure. Do not use growth hormone unless you have one of the three medical conditions for which there is actually evidence that the benefits outweigh the risks.
Update: Diabetes Drug JANUVIA (Sitagliptin)
July 2008
An increasing body of evidence documents both the risks and lack of evidence of clinical benefits associated with sitagliptin, and several reviews have cautioned against its use.
Medications and the Perils of Too Little Sodium in the Blood
July 2008
Low levels of sodium in the blood are one of the most common laboratory abnormalities and the consequences range from mild and non-specific to life-threatening. The article discusses the symptoms of low blood sodium and lists 53 prescription drugs that can cause it. We urge that both patients and health professionals be alert for symptoms that may signal the onset of hyponatremia if the patient is predisposed to this disorder as a result of their drug therapy or diseases.
New Report Sheds Light on Serious Safety Problems with Anti-Smoking Drug Varenicline (CHANTIX)
July 2008
A recent study has found large numbers of reports of psychiatric adverse effects with varenicline (CHANTIX) including hundres of reports of suicidal acts, thoughts or behaviors; possible psychosis; and hostility or aggression.
Black Box Warning for ENBREL (etanercept)
June 2008
Etanercept, an effective disease-modifying anti-rheumatic drug (DMARD), now joins adalimubab (HUMIRA) and inflixamib (REMICADE) to be the third of the arthritis disease-modifying drugs (see discussion on the following page about disease-modifying drugs) to receive a black box warning concerning infections, calling for TB testing and, if positive, TB treatment before starting these drugs. For some people, the potential benefit of etanercept outweighs the risk of infections, including the very small risk of TB infection. The article also discusses a fourth DMARD and the precautions we advise for its use.
Codeine: The Drug With Multiple Personalities
June 2008
Codeine is routinely converted to morphine in the body in order for it to be an effective painkiller. The metabolism of codeine to morphine takes place through the actions of an enzyme in the liver. The article explains how various drugs and or a person's genetic makeup can greatly influence the conversion of codeine to morphine, making its pain-relieving properties too week if not enough conversion occurs and resulting in what amounts to an overdose at the recommended dose if the conversion to morphine is too rapid. Fourteen drugs that inhibit the conversion to morphine are listed in the article.
American Heart Association Recommends Screening for Heart Disease in Children Getting Drugs for ADHD
June 2008
The American Heart Association (AHA) has just recommended specific screening for heart problems for children and adolescents before they get stimulant drugs for treating attention deficit hyperactivity disease (ADHD). The recommendations include a thorough history, a physical exam focussing on the heart and, according to the American Heart Association, that it is reasonable to obtain an electrocardiogram. The article lists the components of an adequate history and physical exam to look for the presence of pre-existing heart disease in children.
Public Citizen Petition Urges Removal of ORTHO-EVRA Patch From Market
June 2008
Last year, US women filled 2.7 million prescriptions for a contraceptive that has, compared to the pill: significantly higher estrogen levels; a possible two-fold increase in the risk of blood clots; increased painful side effects such as breast discomfort, severe menstrual pain, nausea and vomiting; an increased likelihood of discontinued contraceptive use; and no improvement in contraceptive outcomes. The article gives more details about why we want this product banned.
Backsliding on Childhood Immunization
June 2008
More and more Americans are choosing not to have their children vaccinated, and as a result, obsolete diseases are making a come-back.
Human Experimentation and Speedy For-Profit Ethical Review Boards
June 2008
The drug industry uses for-profit human experimentation companies to obtain faster results, to the detriment of the consumer.
Calcium Channel Blocker Drug Interactions
May 2008
This article lists more than 60 prescription drugs that can interact with calcium channel blocking drugs such as amlodipine (NORVASC),diltiazem (CARDIZEM, DILACOR XR TIAZAC)or nifedipine (PROCARDIA)to either cause toxicity or to lessen the effectiveness of the calcium channel blocking drugs. Included in the lists are a number of drugs that we list in Worst Pills, Best Pills as DO NOT USE or LIMITED USE drugs. The article also explains the different kinds of toxicity that can ensue from these interactions.
Nine Reasons Why Older Adults Are More Likely Than Younger Adults to Have Adverse Drug Reactions
May 2008
Older patients are especially at increased risk for adverse drug reactions because of age-related factors.The article reviews nine reasons why this is the case and discusses what you can do about these often-preventable adverse reactions. Increasing awareness of this problem should result in the prescription of far fewer drugs to older adults, and those that are prescribed will be given at lower doses in most instances.
A Review of Modafinil (PROVIGIL) For Narcolepsy
May 2008
PROVIGIL, an amphetamine-like drug, has been illegally promoted by its manufacturer for treating many conditions for which there is no evidence that its benefits outweigh its risks. Thus, a large proportion of prescriptions for this top-200 selling drug are for off-label or unapproved uses.
Serotonin Syndrome Due to Drug Interactions
April 2008
The article lists more than 30 prescription drugs that can cause the serotonin syndrome.
Drug-Induced Eye Toxicity: 62 Drugs That Can Cause Eye Disease
April 2008
This article, based on a recent review in Drug Safety, lists 62 prescription drugs that can cause eye disease. The range of drug-induced eye diseases includes diseases of the eyelids, glaucoma, cataracts, retinal damage and optic nerve damage. As is true for drug-induced diseases in other parts of the body, you should consider newly developed eye symptoms beginning shortly after starting a new medication to be possibly drug-induced and consult a physician.
Advice for Patients: Denture Cleansers
April 2008
Allergic reactions to a component of denture cleansers - persulfates - can occur with both proper and improper use of denture cleansers and can be delayed. Symptoms of an allergic reaction may include: irritation, rash, hives, gum tenderness, breathing problems and low blood pressure.
Avoiding Overuse of Proton Pump Inhibitors (PPIs)
March 2008
This article reviews evidence for the international epidemic of overuse of proton pump inhibitors (PPI), drugs used to treat ulcers and gastroesophageal reflux disease (GERD). There were 70 million prescriptions filled in U.S. pharmacies in 2006 for the four leading PPI drugs: esomeprazole (NEXIUM), lansoprazole (PREVACID), pantoprazole (PROTONIX) and rabeprazole (ACIPHIX). Find out about several serious side effects of these drugs such as increased community-acquired pneumonia, increased hip fractures and acute kidney inflammation. Learn about alternatives to using PPIs.
Get the Mercury Out! Is There a Link Between Childhood Vaccinations and Autism?
March 2008
This article explains what autism is and analyzes the latest evidence concerning its alleged link to mercury from childhood vaccines.
FDA and Drug Makers Should Have Warned Public Earlier About Zetia, Vytorin
March 2008
Find out why Worst Pills warned against the use of VYTORIN more than three years ago. Also, learn about new evidence showing that despite the fact that this drug lowers cholesterol, there is no evidence that it prevents heart attacks or strokes (though massive misleading advertising would have you believe otherwise).
Ibuprofen Can Reduce Aspirin’s Protective Effect Against Heart Attacks and Strokes
March 2008
This article explains the dangers of using ibuprofen (MOTRIN, ADVIL) because it interferes with the protective effect of low-dose aspirin to prevent blood clots and protect against heart attacks or strokes. Find out how these two widely-used therapies have a harmful interaction and what you should do.
Medical Records: Q&A
March 2008
This article reviews such topics as: Why should I have my medical record? Am I entitled to my medical record? Who has access to my medical record? Can a provider deny me access to my record? What if I change health care providers, or my provider has moved or gone out of business? What happens to my record if my provider dies?
Public Citizen Launches New Blog
March 2008
Public Citizen’s communications office launched “Citizen Vox” in February as the organization’s latest tool in spreading the word about its mission of protecting health, safety and democracy. Check out www.CitizenVox.org.
Is Less More? New Study Challenges Conventional Thought on Desirable Cholesterol Levels, Links Very Low Cholesterol to Cancer
February 2008
We review a recent study suggesting that very low cholesterol levels may be linked to an increased risk of cancer. The related issue discussed in the article is whether the current U.S. thinking that "lower is better," especially for those who have not yet had a heart attack or stroke or angina, is correct. There is also a discussion about the difference between primary and secondary prevention.
Update on Rosiglitazone (AVANDIA): More Strikes Against the Drug
February 2008
Recent updates on this diabetes drug that we have urged our readers not to use for three years are reviewed, including the delisting of the drug by the Veterans Administration because of its dangers and warnings by the Canadian government. We are renewing our call for a ban on the drug in the U.S.
Macrolide Antibiotic Drug Interactions
February 2008
The article discusses the adverse drug interactions between either of two widely-prescribed macrolide antibiotics, erythromycin (as in ERYTHROCIN) and clarithromycin (BIAXIN)and more than 40 other drugs that are listed in a table in the article. It also describes the nature of the adverse interactions that can occur.
Drug Industry Spends Almost Twice as Much on Promotion of Drugs as on Research
February 2008
A recent study examined the ways the drug industry spends an average of $61,000 per physician each year trying to convince them to buy certain drugs. The findings provide a well-documented reminder that the industry is much more financially committed to massive promotional expenses than to research and development of drugs.
Painkiller DARVOCET Now Phased Out of U.K. Market; Still Widely Prescribed in the U.S.
January 2008
Why is this big-selling, extremely dangerous, not very effective narcotic painkiller still on the market in the U.S. despite haveing been withdrawn in the U.K.? Learn about how it kills more than 200 people a year.
SSRIs Can Have Dangerous Interactions With Other Drugs
January 2008
More than 70 million prescriptions a year are filled for these popular antidepressants, including Prozac, Paxil, Zoloft, Luvox, Celexa and Lexapro. This article gives details about more than 60 other widely prescribed prescription drugs that can have harmful interactions if used with these antidepressants. The two different kinds of interactions are also discussed.
Reporting Adverse Events from Drugs and Medical Devices to the Food and Drug Administration
January 2008
Learn how you can easily report to the FDA an adverse reaction you have had to a drug or dietary supplement. The basis for most drugs being taken off the market or being required to have a black box warning are such reports. Do your part!
Pay for Performance? Incentives Gone Awry
January 2008
This article reviews an example of the growing trend of paying doctors more for "better" performance. Referring to doctors getting financial kickbacks for prescribing generic drugs, the article points out that doing the right thing for the wrong reason is not acceptable. Having doctors increasingly basing their decision-making on financial conflicts of interest is not in patients' interests.
Taking TOPAMAX to Treat Alcoholism Could Have Serious Consequences
December 2007
A recent drug industry-funded study was widely hailed as showing that TOPAMAX, a drug approved for seizures and migraines, worked well in treating alcoholism in heavy drinkers. However, upon closer inspection, the study does not convincingly prove the safety or effectiveness of the new suggested use of topiramate. The use of the drug produced only a modest decrease in the percentage of days of heavy drinking, compared to placebo. Topiramate can be unsafe if mixed with alcohol. Current FDA labeling for the approved uses of the drug states, “You should avoid drinking alcohol while taking [topiramate]. Alcohol with [topiramate] can make side effects such as sleepiness and dizziness worse.” In addition. the drug can cause metabolic acidosis, a condition that occurs when there is too much acid in your blood. Metabolic acidosis can cause symptoms such as tiredness, loss of appetite, irregular heartbeat and impaired consciousness.
Drug Interactions: Warfarin (COUMADIN)
December 2007
This article explains how to understand the International Normalized Ratio (INR), a test applied to a sample of a patient’s blood to determine how “thin” it is when you are using the blood thinner COUMADIN (warfarin). In addition, the article lists more than 50 drugs or dietary supplements that can interact harmfully with COUMADIN to cause the blood to be too thin (abnormal bleeding) or not thin enough which could result in lessening the effect of COUMADIN in stopping blood clot formation.
What Happened in U.S. Health Care in 2007?
December 2007
This article summarizes 14 important health events that occurred in 2007, including seven that involve the pharmaceutical industry or its increasingly close financial partner, the FDA. Seven other reviews involve our so-called health care system.
New European Warnings and Restrictions on Painkiller Piroxicam (FELDENE): FDA Fails to Issue New Warning
November 2007
The European Medicines Agency (EMEA) has issued new warnings for the painkiller/arthritis drug piroxicam (Feldene). The drug "was singled out for special review because piroxicam-containing medicines are associated with more gastro intestinal side effects and more serious skin reactions than other non-selective NSAIDs." In a series of published studies, in comparison to ibuprofen (ADVIL, MOTRIN), piroxicam was between 2.8 and 7.1 times more likely to be associated with severe gastrointestinal toxicity, defined as bleeding, ulceration or perforation. No other NSAID was as consistently as high in gastrointestinal risk as piroxicam. We continue to recommend that this uniquely dangerous drug be classified as Do Not Use.
Harmful Interactions Between Smoking and Prescription Drugs
November 2007
Something never mentioned on cigarette warning labels is that smoking can affect the way a number of medications work, in some cases resulting in significant, dangerous adverse outcomes. Smokers should be aware that a number of medications may not work as well because of smoking cigarettes. The article lists 16 drugs whose levels in the blood become lower, making the drugs less effective, if the patient is also smoking.
Drug Interactions 101
November 2007
This month marks the beginning of an important addition to every issue of Worst Pills, Best Pills News concerning drug interactions. The articles are being written by one of the world’s top authorities on interactions, Dr. Philip Hansten of the University of Washington. This introductory article explains how to understand different types of interactions and every month, starting now, there will be a specific article on the adverse interaction of the month.
Trials and Tribulations: How the FDA Fails to Adequately Oversee Human Experiments
November 2007
A September 2007 report by the Inspector General (IG) of the Department of Health and Human Services suggests that there has been inadequate oversight of clinical trials in which experimental drugs are used, to the possible detriment of the patients in these studies. People who are willing to take risks to benefit science and society deserve respect, even honor and certainly protection. They are entitled to a system that can monitor clinical trials and that can correct deficiencies before it is too late. What they have instead is a system that is more interested in the data they generate than their well-being.
Rethinking Health Care for the Elderly
November 2007
The authors of a recent British Medical Journal article plead for physicians to take a more global look at their patients, not to focus on individual diseases, and especially not to turn healthy patients into “sick” ones by the inappropriate use of certain prescription drugs. Rather than putting people on drugs for prevention of a disease they might never have, they recommend using the available money to improve the quality of life of their patients (e.g., provide cataract operations, joint replacement surgery, and personal care of those with dementia). Physicians should not turn the elderly population into patients worried about disease. Instead, they should provide them with the care needed to increase their enjoyment of day-to-day life.
“Reminder” Ads: Innuendo Minus Information
November 2007
At present, facing increasing competition and dwindling sales, Pfizer has launched a “reminder” ad for Viagra that skirts FDA requirements. Because any ad that mentions the product’s name and the condition that it treats must also disclose its side effects, Pfizer has eclipsed its message with a song and an image. The song is “Viva Viagra” (to the tune of “Viva Las Vegas”) and the image is that of a jam session of guitar-playing 40-something-year-old men singing about their “not straying” and their devotion to an unseen “she.” The ad omits a caution against sexually transmitted diseases (STDs) and HIV, although this is flashed briefly on the screen. The result is an undermining of the pharmaceutical manufacturers’ original rationale for direct-to-consumer advertising: that it would be a tool to provide important information to patients who would benefit from the knowledge.
Another U.S. Go-It-Alone Policy: Direct-to-Consumer Advertising
November 2007
The U.S. is essentially isolated when it comes to permitting Direct-to-Consumer (DTC) ads. Other than the U.S., only New Zealand has ever permitted such ads – and health authorities there have been recently struggling valiantly to put an end to them. Here in the U.S., the problem is more intractable. A veritable army of drug companies and advertisers, to say nothing of their now DTC-dependent counterparts in the print and electronic media, now exists to resist any challenge to the primacy of these ads. But the ultimate culprit is the government. By failing to provide objective information on medications, the FDA, in particular, has ceded its authority and delivered a massive nest egg to industry – with the usual, predictable results. The best we can hope for is that no other countries follow us down this garden path.
HRG’s Quack-o-Meter: Tips to Detect Fraud in the Marketing of Drugs and Devices
November 2007
Consumers are bombarded with claims about new medications, diets and devices. These claims promise much, and there is no guarantee that they will deliver. In fact, there are usually indicators that they will not deliver. In order to alert consumers to some of the tell-tale signs of questionable products, we have devised a quack-o-meter to assess these products. The article lists 10 different sorts of "quacks" that should alert people to the possibility/probability of fraudulent health products.
EU Warns About BOTOX Dangers: Why has the US failed to inform its residents?
October 2007
The European Union has warned that Botox can travel from the site of injection and cause muscle paralysis at other sites. The consequences can include difficulty swallowing and inhaling of food into the lungs. The US FDA has not issued similar warnings.
Hoodia: The Latest in a String of Diet Pill Scams
October 2007
Hoodia is a Southern African succulent that is claimed to reduce the craving for food. In fact, it is just the latest in the long line of dietary supplements making unproven weight-loss claims.
Drug-Induced Diseases: Part 2
October 2007
This article describes patients who have had side effects of drugs, in some cases leading to years of misdiagnosis. It also provides a list of common conditions that can be caused by drugs and some drugs that cause them.
Research as Public Relations: Antidepressants and Suicide in Youth
October 2007
Because of evidence from a number of studies, the Food and Drug Administration (FDA) recently required a “black box” label for all SSRI (selective serotonin reuptake inhibitor) antidepressants indicating that use in children could lead to an increased risk of suicidal behavior. Now comes a study published in the prestigious American Journal of Psychiatry (Volume 164, pp. 1356-1363) purporting to show, in effect, the opposite: the FDA warnings had caused the rate of pediatric SSRI prescriptions to plummet and as a result young people are killing themselves due to lack of treatment. If this were true, it would be a clear example of the unintended consequences of regulation. The paper and its subsequent publicity appear to be little more than a public relations ploy. The editors of the AJP should not have allowed such gross misrepresentations to pass into print unscathed, and journalists who cited this study as if it deserved equal credence to the RCTs are just as guilty.
A Review of Varenicline (CHANTIX) To Quit Smoking
September 2007
Varenicline was approved by the FDA in May 2006 for use as an aid in smoking cessation treatment. It belongs to a new family of drugs, not containing nicotine, but thought to work by stimulating nicotine receptors in the brain, just as nicotine does.
Drug-Induced Diseases
September 2007
This is the first of two articles discussing drug-induced diseases, often mistaken for these diseases that commonly occur even if you are not taking drugs. Examples include drug-induced depression, hallucinations, confusion, delirium, memory loss, impaired thinking as well as neurologic problems such as parkinsonism, involuntary movements of the face, arms, legs (tardive dyskinesia), and sexual dysfunction.
Manipulating the Hispanic Market: The Case of Viagra
September 2007
This article describes Pfizer's attempts to promote Viagra for erectile dysfunction by targeting Latinos, in part through support to a Latino physicians association.
Improving Public Access to Clinical Trial Information
September 2007
Clinical trials databases can disclose that a trial is taking place and the results of the trial once it is completed. Our international study of such databases shows that only a government-run database is likely to produce a comprehensive, consumer-friendly database.
Pharmacists Ordered to Distribute Medication Guides About Serious Heart, Psychiatric Problems Linked to Attention Deficit Drugs
August 2007
Patients currently taking drugs approved for the treatment of ADHD who experience any of the cardiac or psychiatric side effects mentioned in this article are advised to seek medical attention immediately.
FDA Issues New Warnings For Muscle Spasm Drug Tizanidine (ZANAFLEX)
August 2007
The muscle spasm drug tizanidine (ZANAFLEX) combined with certain other drugs could cause serious complications such as drowsiness and can dramatically lower blood pressure, according to the Food and Drug Administration (FDA). The article lists 20 drugs to avoid if you are using Zanaflex so that you avoid these potentially dangerous interactions.
Older Adults May Have Low Blood Sodium Levels When Using the Antidepressant Venlafaxine (EFFEXOR)
August 2007
Patients over the age of 65 taking or considering taking venlafaxine (EFFEXOR) should ask their provider to check for low blood sodium levels within three to five days after treatment is started. Patients taking venlafaxine who are experiencing the symptoms of low blood sodium levels listed in the article should contact the prescriber as soon as possible. Patients should not discontinue taking venlafaxine without first consulting with their prescribing health care provider. Other antidepressants in the SSRI family such as PROZAC and PAXIL have also been found to cause low sodium levels.
XYZAL: A Not-So-New Antihistamine
August 2007
There is no medical reason that you should be taking levocetirizine (XYZAL) rather than one of the many other prescription and non-prescription antihistamines that are available in the market. The article discusses alternatives.
Q&A on the Human Papilloma Virus Vaccine Gardasil
August 2007
The article answers 18 commonly asked questions about the new vaccine for preventing cervical cancer such as: Won’t the HPV vaccine cause an increase in teen sexual activity? While this has also not been studied, this seems very unlikely to us. Of all the factors young women (and men) take into consideration when deciding whether to have sex, a vaccination, years previously, against an infection they may not have heard of seems unlikely to rank high.
What are the Presidential Candidates Talking About? A Brief Dictionary of Health Policy Terms
August 2007
The article explains 15 of the most commonly used terms involving types of health insurance now being debated nationally, such as the difference between a market-based, pay-or-play, Medicare-for-all and single payer systems.
New Findings: AVANDIA Poses Risks of Heart Attacks, Heart Failure
July 2007
In addition to years-old information about increased heart failure in patients using AVANDIA, that Worst Pills readers have been warned about for years, new evidence has emerged about increased heart attacks as well. The article reviews the evidence for both of these serious problems and why we continue to advise people not to use either AVANDIA or the related drug, ACTOS.
FDA: Women Taking AVANDIA, ACTOS at Increased Risk of Fractures
July 2007
Yet another reason has arisen to support our several years-old warning not to use the diabetes drugs AVANDIA or ACTOS. Randomized trials of both drugs, compared to other diabetes drugs, showed an increase in fractures in women (not men) using them.
Human Growth Hormone Not Recommended as Antiaging Treatment
July 2007
The harms of human growth hormone outweigh any benefit when used in healthy elderly individuals, according to a systematic review of randomized controlled trials. The article lists a number of side effects caused by growth hormone in otherwise healthy elderly people. The antiaging industry has established a new low in disease mongering by turning the normal aging process into a disease that can be treated by growth hormone.
FDA: All Antidepressants Should Carry Warnings About Risks of Suicidal Thoughts in Young Adults
July 2007
Because of new information about increased risks of suicidal thoughts associated with the use of a variety of antidepressants, people of all ages should be monitored closely with all antidepressants after the drugs are first prescribed, switched or when the dosage is changed. Do not stop using any antidepressants without first consulting the prescriber.
Desmopressin Removed From UK Market for Bedwetting But Still Approved in the US
July 2007
The government in the UK has removed the approval of desmopressin nasal spray for bedwetting because it can cause low sodium and life-threatening swelling of the brain. In the US, however, the drug is still approved for this purpose. The article discusses symptoms of low sodium induced brain swelling that should lead to seeking emergency medical help.
Sitagliptin (JANUVIA) for Type-2 Diabetes
June 2007
Worst Pills, Best Pills reviews side effects and long-term effects of type-2 diabetes drug sitagliptin (JANUVIA) in this article.
Drugmaker Removes Parkinson's Disease Medication from the Market; Drug Linked to Heart Valve Damage
June 2007
On March 29, 2007, the Parkinson’s disease drug pergolide (PERMAX) was withdrawn from the market. This follows the publication of two studies which show an increased risk of heart valve damage in patients taking pergolide compared to those not taking the drug. You should contact your health care professional immediately if you are taking pergolide to discuss other treatments. Do not discontinue taking pergolide abruptly. The dosage of the drug must be gradually decreased.
The Diet Drug Orlistat (XENICAL) and Gallstones
June 2007
Yet another problem has been detected with this diet drug whose approval we opposed and that we have been attempting to get banned. The FDA found 37 cases of gall stones in patients using orlistat. This, in addition to inhibiting the absorption of important vitamins such as A, D, E and K as well as evidence that the drug can cause pre-cancerous abnormalities in the colon of animals, further emphasizes why this barely effective drug should not be used, either in the prescription version called Xenical or the about-to-appear over-the-counter version, Alli.
Antibiotic Telithromycin (KETEK) Can Cause Liver Damage, Respiratory Failure and Death
June 2007
If you experience one or more of the signs of liver toxicity listed in the article, you should stop taking telithromycin and call your physician immediately. Do not take another dose of the drug unless instructed to do so by your physician.
FDA Pulls ZELNORM Off the Market for Safety Reasons
June 2007
The Food and Drug Administration (FDA) removed tegaserod (ZELNORM), a widely prescribed constipation drug, from the market on March 30, 2007. Public Citizen wrote a letter to the FDA opposing the approval of this drug in March 2001 because studies showed it to be only marginally effective. Further, the drug exhibited serious safety problems in clinical trials before it was approved, including an increased incidence of non-cancerous ovarian cysts and a five-fold increase in fainting compared to patients receiving a placebo. For the past three years, we have urged readers of Worst Pills not to use the drug. If you are currently taking tegaserod, you should contact your physician right away to discuss alternative treatments.
Methadone for Pain
May 2007
A few months ago the FDA warned about the potential of methadone - when used to treat pain - to cause life-threatening breathing problems and heart rhythm disturbances. When it made this safety announcement, however, the FDA negligently failed to point out that they had recommended a drastic reduction in the starting dose for pain to prevent some of these life-threatening adverse reactions. The new recommended starting dose is more than a 2.5 fold reduction in the dosage for the initial treatment of pain. Symptoms of overdose with the older, higher doses are discussed in the article.
Don't Get Sold By Drug Ads on TV, Says Study
May 2007
Not only does this study find that consumer drug ads are not educational, it also says that the ads may oversell the benefits of the drugs and could put the public health in danger. For example, of the 24 drugs included in this advertising study, seven are listed as Do Not Use in Worst Pills, Best Pills publications. You should not rely on direct-to-consumer television advertisements as a source of drug information.
FDA Requests New Safety Warnings for AMBIEN (Zolpidem), Other Sleeping Pills
May 2007
Patients taking sleep medications could be at risk of severe allergic reactions and complex sleep-related behaviors, which may include sleep driving, driving while not fully awake after ingestion of a sleeping pill, with no memory of the event, according to the FDA. DO NOT suddenly stop taking sleeping pills without consulting your physician because of the possibility of withdrawal reactions.
Public Citizen Petitions FDA To Ban Oral Contraceptives Containing Desogestrel
April 2007
Public Citizen's Health Research Group filed a petition with the Food and Drug Administration (FDA) on February 6, 2007, to ban the sale of all third-generation oral contraceptives (OCs), which double the risk of potentially life-threatening blood clots compared to second-generation birth control pills. A list of these oral contraceptives that contain desogestrel accompanies this article.
A Review of Lubiprostone (AMITIZA) For Chronic Constipation
April 2007
The long-term safety of lubiprostone is unknown. Because lubiprostone is the first in a new class of drugs that works in a new way, it is possible that unknown and unpredictable side effects may occur after the drug is used in large numbers of patients.
Dangerous Abnormal Behavior In Children And Adolescents Treated With Flu Drug Oseltamivir (TAMIFLU)
April 2007
Roche Laboratories Inc., announced on November 14, 2006, that new precautions have been added to Tamiflu's professional product label (also known as a package insert) about the possibility of abnormal behavior in children and adolescents that, in extreme cases, has resulted in deaths. Oseltamivir should be stopped immediately if the person taking this drug develops abnormal behavior, delirium, hallucinations, delusions, aggression, suicidal ideation and/or other mental status changes while taking the drug to treat the flu.
Adverse Reactions to Cough and Cold Meds Sent 1500 Babies to the Emergency Room in 2004, 2005
March 2007
Prescription and over-the-counter cough and cold medications should not be used in children younger than 2 years of age. For example, the American Academy of Pediatrics issued a policy statement advising that parents should be told that efficacy of the cough suppressants codeine and dextromethorphan in young children was unproven, and that there is a potential for adverse drug reactions.
A Review of Ranolazine (RANEXA) For Chronic Chest Pain
March 2007
Although the FDA medical officer in charge of reviewing ranolazine recommended that ranolazine's professional product labeling display a black box warning about potential disruption in the heart's electrical cycle, the drug does not have a black box warning.
Black Cohosh Does Not Relieve Symptoms of Menopause
March 2007
There is reliable evidence that products containing black cohosh do not help menopausal symptoms compared to no treatment at all and there is growing evidence of substantial harm, such as liver toxicity, with the use of this dietary supplement.
Serious Safety Concerns With Unapproved Pharmacy-Compounded Topical Anesthetics and Other Drugs
February 2007
Some of the names used for these products are: Anesthetic Skin Lotion (containing lidocaine and prilocaine), Tetracaine in DMSO Gel (tetracaine and dimethyl sulfoxide) and Triple Kwick Anesthetic Gel (benzocaine, lidocaine and tetracaine), N*E*W* topical anesthetic (lidocaine, prilocaine and tetracaine), Kwick Anesthetic Gel (benzocaine, lidocaine, tetracaine and dimethyl sulfoxide), Lidocaine and Tetracaine Demi Gel and Anesthetic Skin Gel 3+ (lidocaine, prilocaine and tetracaine). The article explains the risks of each.
Life-Threatening Adverse Effects and Deaths Reported in Patients Using Methadone (DOLOPHINE) for Pain Relief
February 2007
Deaths, cardiac and respiratory, have been reported during initiation and conversion of pain patients to methadone treatment from treatment with other opioid agonists. Because methadone has some of the effects of other narcotics, do not stop the drug without consulting the prescriber because of the possibility of serious and uncomfortable withdrawal symptoms.
FDA Warns Against the Use of Quinine to Prevent Nocturnal Leg Cramps, Orders Unapproved Quinine Drugs Off the Market
February 2007
The use of unapproved quinine-containing drugs to prevent nocturnal leg cramps poses serious safety concerns, including the risk of death, according to a December 11, 2006, warning from the Food and Drug Administration (FDA). The risk associated with the use of quinine sulfate in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps, outweighs any potential benefit in treating and/or preventing this benign, self-limiting condition.
A Review of Levalbuterol (XOPENEX HFA) Inhaler for Asthma
February 2007
If you are presently using albuterol and your asthma is adequately controlled, there is no medical reason why you should be switched to levalbuterol. There is no convincing evidence that it is any safer or more effective than the older, much less expensive short-acting beta agonist, albuterol.
FDA Should Not Seek More Drug Company Money, Should Get All Funding From U.S. Treasury
February 2007
The Food and Drug Administration (FDA)is proposing that the Prescription Drug User Fee Act (PDUFA) be reauthorized by Congress this year and that under the act, drug companies give the agency nearly $400 million a year. The FDA's crucial drug regulatory functions are too important to be tainted and compromised by direct funding from the very companies whose drugs the agency reviews for safety.
Conflicts of Interest: An Issue That Will Not Go Away
February 2007
Recent data confirm that drug manufacturers are also savvy marketers, and that they consider physicians to be a prime target. In 2004 drug companies spent a total of $7.8 billion influencing physicians. This computes to an average of $10,000 for every practicing doctor in the United States. If these companies gave each doctor a check for this amount, we would be duly outraged.
Conflicts of Interest Among Clinical Investigators
February 2007
Imagine the following: You are involved in a lawsuit against a manufacturer whose product you say caused you injury. During the trial, you get the impression that the judge is favoring your opponent; ruling to his or her advantage on motions, objections, evidence and the like, and you end up losing. Later, you learn that the judge had a significant financial interest in the form of stocks and stock options in the company you sued. Would you suspect that you had been had by a biased judge? You bet!
Adverse Drug Reactions Cause 1.4 Million Emergency Room Visits in 2004 and 2005
January 2007
An estimated 701,547 patients were treated for adverse drug reactions in emergency rooms each year in 2004 and 2005, totaling 1.4 million visits to the emergency room. Of these, an estimated 117,318 patients were hospitalized each year. According to the study. 18 drugs were each, either independently or in combination with other drugs, implicated in one percent or more of the estimated adverse drug events. These drugs are listed in the table that accompanies this article along with the annual estimates of adverse drug events.
Using Seizure and Depression Drug Lamotrigine (LAMICTAL) While Pregnant May Result in Birth Defects
January 2007
The seizure and depression drug lamotrigine (LAMICTAL) may cause birth defects when taken during the first trimester of pregnancy. Specifically, the drug may cause either or both cleft lip (a gap in the upper lip) and cleft palate (a gap the roof of the mouth) in babies. If you are taking lamotrigine and become pregnant, consult the prescribing physician immediately. DO NOT discontinue any seizure medication without first consulting the prescriber.
Using Oral Terbinafine (LAMISIL) for Fungal Infections Poses Risks to Your Health
January 2007
Serious health complications involving toxicity to the bone marrow have been reported in association with the drug terbinafine (LAMISIL), according to the August 2006 edition of the Australian Adverse Drug Reactions Bulletin. This is in addition to the hundreds of cases of liver toxicity that were the cause of our listing this drug as Do Not Use.
New Research: Cognitive Behavioral Therapy to Treat Insomnia is Superior to Sleeping Pills Such as Eszopiclone (LUNESTA)
January 2007
Cognitive behavioral therapy is a safer, more effective alternative to taking sleeping pills such as zopiclone or eszopiclone (Lunesta). DO NOT ABRUPTLY DISCONTINUE ANY SLEEP MEDICATION BECAUSE OF THE POSSIBILITY OF WITHDRAWAL REACTIONS.
Dr. Wolfe’s Diet Revolution
January 2007
The article describes, in detail, a safe, sustainable combination of diet and exercise that enables people to lose one pound per week.
Conflicts of Interest: The Hidden Side of Science
January 2007
New evidence indicates that conflicts of interest permeate much of what passes as unbiased scientific judgment, and that three gatekeepers of medical knowledge the National Institutes of Health, institutional review boards monitoring human experimentation, and major medical journals are part of the problem.
FDA-Approved Drug Information Now Required For The Blood Thinner Warfarin (COUMADIN)
December 2006
The Food and Drug Administration (FDA) announced October 10 that an agency-approved Medication Guide, which provides information about drug safety, will now be required to accompany all new and refill prescriptions for the blood thinner warfarin (COUMADIN). Warfarin can interact dangerously with a number of other drugs, dietary supplements and vitamins, but these products are inexplicably not listed in the Medication Guide. The details of these serioius interactions can be found at Worstpills.org or in our book, Worst Pills, Best Pills.
The Case Against The Diabetes Drug Rosiglitazone (AVANDIA)
December 2006
In addition, there was an almost significant 37 percent excess in the rosiglitazone group of what the authors called cardiovascular events composite, comprised of heart attacks, strokes, cardiovascular deaths, heart failure, the appearance of new angina attacks, and the need for heart surgery such as bypass or angioplasty. You have a greater likelihood of preventing type 2 diabetes by improving your diet and getting a moderate amount of exercise than by taking a prescription drug. The effects of such a change in lifestyle can last a lifetime.
Reporting Adverse Events From Drugs and Medical Devices To The Food and Drug Administration
December 2006
Consumers can play a vital role in protecting the public health by reporting to the Food and Drug Administration the often serious health problems they experience while taking prescription drugs and dietary and herbal supplements or while using medical devices. The article details different ways to report to the FDA.
FDA Issues Stronger Warnings for ADHD Stimulants; Warnings Don’t Go Far Enough
November 2006
If you are considering treatment with a stimulant ADHD drug for yourself or your child, become familiar with the new warnings for these drugs that are presented in this article. The new warnings do not tell patients that the drugs can also cause sudden death in those using the medication properly, not just in those abusing the drugs.
Used as a Glaucoma Treatment, Beta-Blocker Eye Drops May Cause Serious Adverse Reactions in Some Patients
November 2006
You should not use beta blocker eye drops to treat glaucoma if you have pre-existing breathing or certain heart conditions.
Public Citizen Urges FDA to Warn Consumers About Risk of Tendon Rupture Associated With Certain Antibiotics
November 2006
You should stop taking fluoroquinolones(listed in the article) and immediately contact your physician if you experience pain in any tendon while taking one of these antibiotics so you can be switched to another antibiotic.
Canadian Government Warns Against the Use of Dietary Supplement L-Arginine in Patients Who Have Had a Heart Attack
November 2006
A study published in the Journal of the American Medical Association found an increased risk of death in patients using l-arginine after a heart attack. L-arginine is widely promoted on the Internet for a number of conditions, including protecting the heart.
Bogus Cures for Diabetes on the Internet
November 2006
A joint effort of the Food and Drug Administration (FDA) and the Federal Trade Commission(FTC) has resulted in recent warning letters to a large number of companies who are illegally marketing unproven diabetes treatments online. The article lists many of these products.
Internet-Sold Dietary Supplements For Erectile Dysfunction May Endanger Users
October 2006
The FDA analysis found that some of these products illegally contained sildenafil (VIAGRA), which is FDA-approved for erectile dysfunction. Others contained chemicals similar to sildenafil.
PUBLIC HEALTH ADVISORY: Migraine Drugs, Antidepressants May Cause Life-Threatening Interactions
October 2006
If you are taking triptans, SSRIs or SNRIs and experience the symptoms of serotonin syndrome listed in this article, you should seek medical attention immediately. This is because of the possibility of life-threatening reactions such as nausea, changes in blood pressure or hallucinations that may be caused by the interaction of migraine headache drugs, called triptans, and certain antidepressants.
A Review of Ibandronate (BONIVA) For Osteoporosis
October 2006
Although this osteoporosis drug has been shown to decrease vertebral fractures, which involve the bones that make up the spine, the drug did not show any decrease in nonvertebral fractures, such as hip fractures, in postmenopausal women. We know more about the older, alternative drugs for osteoporosis.
PUBLIC HEALTH ADVISORY: Continuing Antidepressants During Pregnancy May Help Mother, Harm Baby: A Medical Dilemma
October 2006
Women who are pregnant and taking certain antidepressants take note: a recent study finds that you are more likely to have a recurrence of depression if you stop treatment during pregnancy, but another recent study suggests that taking certain antidepressants may harm your baby. Find out about this dilemma.
No 'Alternative'
October 2006
Placebos are very powerful. Beyond yoga for lower back pain and acupuncture for analgesia, there has not been a study showing an unequivocal benefit of an alternative therapy when subjected to the rigor of an NIH trial. This negative outcome should not be greeted smugly, because most experimental drugs developed by pharmaceutical or biotechnology companies fail to fulfill their promise.
New Study Links Signs of Possible Liver Damage to Lower Doses of Acetaminophen (TYLENOL), Supporting Previous Research
September 2006
The authors of the study commented that their review of previously published medical studies supports their observations that some healthy adult patients in clinical trials developed ALT elevations when repeatedly treated with four grams of acetaminophen daily,which is within the recommended dosage range for the drug.
Death of Parts of the Jaw Bone With Osteoporosis Drugs Such As Alendronate (FOSAMAX)
September 2006
The typical signs and symptoms of osteonecrosis of the jaw may include pain, swelling or infection of the gums, loosening of the teeth, poor healing of the gums, numbness or a feeling of heaviness in the jaw, drainage and exposed bone. Patients taking a bisphosphonate (including Fosamax) should carefully monitor themselves for any sign of jaw problems resembling those described in this article.
A Review of the Antibiotic Telithromycin (KETEK)
September 2006
The Food and Drug Administration (FDA) announced that new warnings about liver toxicity, including the possibility of death, have been added to the package insert for the antibiotic telithromycin (KETEK).
For Prescriptions, Eye Doctors Recommend Using One Drop per Eye, Not Two
September 2006
Ophthalmologists consulting for the Medical Letter generally agree that all eye drops should only be used in a dose of one drop because there is a smaller chance of an overdose with one drop. Also, using one drop instead of two makes more efficient use of the medicine.
Fairness Creams in South Asia — A Case of Disease Mongering?
September 2006
Promoting a particular body image or behavior pattern as the preferred one and then selling medicines or products to help people attain the particular ideal may be regarded as disease mongering. Fairness cream manufacturers have exploited the preference for fair skin, portrayed it as a necessary prerequisite for success, and promoted the use of their product to achieve the ideal. Controlled studies on the efficacy and safety of fairness creams are lacking.
FDA Public Health Advisory: Birth Defects with High Blood Pressure-Lowering Drugs Containing Angiotensin-Converting Enzyme (ACE) Inhibitors
August 2006
Because of the risk of birth defects, you should contact your physician immediately if you are pregnant and are taking either an ACE or ARB inhibitor at any stage in pregnancy. DO NOT discontinue a blood pressure-lowering drug without first consulting the prescriber.
A Review of Bioidentical Hormone Replacement Therapy (BHRT) Manufactured by Compounding Pharmacists
August 2006
Two industries peddling hormone replacement drugs became involved in a conflict with one another on October 6, 2005, when the pharmaceutical company Wyeth filed a petition with the FDA urging the agency to counter flagrant violations of the law by pharmacies compounding Bioidentical Hormone Replacement Therapy Drugs. Both sides have been very culpable in assaults on women's health.
Deaths In Children Using Promethazine (PHENERGAN) Increase; FDA Issues a Safety Alert and a Stronger Black Box Warning
August 2006
PHENERGAN should not be used in pediatric patients less than two years of age because of the potential for fatal respiratory depression. It is also advisable that the drug not be given to children less than 16 years of age.
Dietary Supplement Black Cohosh Linked to Liver Toxicity
August 2006
49 cases of liver toxicity worldwide have been associated with the use of the dietary supplement black cohosh.
Pharmaceutical Marketing and the Invention of the Medical Consumer
August 2006
An anthropologist comments insightfully on the pharmaceutical industry's exploitation of medical consumers. He concludes that "[I]n our pursuit of a near-utopian promise of perfect health, we have, without realizing it, given corporate marketers free reign to take control of the true instruments of our freedom: objectivity in science, ethics and fairness in health care, and the privilege to endow medicine with the autonomy to fulfill its oath to work for the benefit of the sick."
Women Should Wait to Use Osteoporosis Drug Raloxifene (EVISTA) to Prevent Breast Cancer
July 2006
You should wait to use raloxifene for reducing the risk of breast cancer until the drug is FDA approved for this use.
Off-label Prescribing: Prescribing without Proof Can Lead to Harm
July 2006
21 percent of the prescriptions written in 2001 in the United States were for drugs that were not deemed to be safe and effective to treat the diseases or symptoms for which they were prescribed. If you have been prescribed a drug for an off-label (unapproved) use, ask your physician about the science supporting the use of the drug and ask if a drug that is approved for that use could be substituted.
The Danger of Prescribing without Proof: Examples of Prescriptions for Drugs Not Shown to be Safe and Effective
July 2006
The article discusses numerous recent examples of the harm that has been caused by off-label prescribing, including the heart drugs amiodarone (Cordarone), many antipsychotic drugs, topiramate (Topamax)and several antidepressants.
Increased Personal Care Provides Alternative to Antipsychotic Drugs for Elderly Dementia Patients
July 2006
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo...The percentage of patients using antipsychotic drugs in the six nursing homes receiving training and support was significantly lower (23 percent) than that in the nursing homes whose patients received usual care (42.1 percent).
Public Citizen Asks FDA to Immediately Remove Orlistat (XENICAL) from the Market
June 2006
Public Citizen petitioned the Food and Drug Administration (FDA) on Apr. 10, 2006 to immediately remove the diet drug orlistat (XENICAL) from the market. The basis for the petition is the fact that orlistat can cause pre-cancerous changes in the lining of the intestines called aberrant crypt foci (ACF). You should not take orlistat. There is no evidence that this drug can reduce the health risks associated with obesity and inactivity, and the drug's minimal effectiveness for weight loss-coupled with both the real and theoretical risks of orlistat-outweigh any known benefit for the drug.
Health Research Group Petitions to Phase Out the Sale of the Painkiller Propoxyphene (DARVON, DARVOCET, and Generic Versions)
June 2006
On Feb. 28, 2006, the Health Research Group petitioned the Food and Drug Administration (FDA) to immediately begin phasing out the sale of the dangerous painkiller propoxyphene (DARVON). The reason for the petition is that propoxyphene has been associated with over 10,000 confirmed deaths and 2,110 reported accidental deaths in the U.S. from 1981 through 1999. There are many generic versions of propoxyphene on the market, as well as a number of products that combine propoxyphene with acetaminophen (TYLENOL). These products are sold as DARVOCET and are also widely sold as generic drugs. A phased withdrawal, instead of an immediate ban, is necessary because of the addicting properties of the drug and the need to switch patients to other painkillers.
Nightmares Associated with Atorvastatin (LIPITOR)
June 2006
Assume that any new symptom you develop after starting a new drug may be caused by the drug. If you develop a new symptom after starting atorvastatin or other statins (such as nightmares), report it to your doctor. The drug may be responsible.
Folic Acid and B Vitamins No Better Than Placebo in Heart Patients and May Cause Harm
June 2006
You should not use combinations of folic acid and B vitamins to lower blood levels of homocystine with the goal of preventing heart attacks, strokes, or sudden death. There is no evidence of a beneficial effect of these vitamins, and there is a possibility that they may cause harm.
Lung Inflammation (Pneumonitis) with the Arthritis Drug Leflunomide (ARAVA)
June 2006
There is increasing evidence that the arthritis drug leflunomide (ARAVA), taken alone or in combination with another drug, methotrexate, can case serious lung inflammation called pneumonitis. If you are taking leflunomide, either alone or in combination with methotrexate, and you experience difficulty breathing, a dry cough, and dizziness, you should contact your physician immediately.
Poll: People Understand Systemic Problems at FDA
June 2006
A Harris poll released on May 24th found that 58 percent of 2,371 people surveyed last week thought that the Food and Drug Administration (FDA) does only a fair or poor job ensuring the safety and efficacy of new prescription drugs, a significantly worse assessment than as recently as two years ago. This shows that the public has caught on to the systemic problems at the FDA — problems that jeopardize the health of millions of prescription drug users in this country.
Pharmaceuticals Need Price Controls
June 2006
Every other substantial country in the world has some kind of government price controls on pharmaceutical manufacturers. This policy assures that any savings realized go to the government and taxpayers rather than being diverted to profits of a middleman.
Adding Clopidogrel to Aspirin Offers No Benefit in Preventing Heart Attacks or Strokes
May 2006
If you have had a previous heart attack or stroke or have blood vessel disease, you should be on aspirin treatment rather than clopidogrel with or without aspirin. You should only take clopidogrel if you cannot tolerate aspirin.
Celecoxib (CELEBREX) May Double the Risk for Heart Attacks Compared to Older Arthritis Drugs
May 2006
New research published in the March 2006 edition of the Journal of the Royal Society of Medicine indicates that the popular arthritis and painkilling drug celecoxib (CELEBREX) may double the risk for heart attacks compared to older arthritis medications.
Glucosamine and Chondroitin for Knee Arthritis - Still No Evidence of Effectiveness
May 2006
In the most rigorous study to date, there was no evidence of effectiveness for glucosamine, chondroitin or the two together. We continue to recommend against the use of these unregulated supplements.
FDA Relegates ADVAIR and SEREVENT to Last Choice Status for Asthma Treatment
May 2006
ADVAIR DISKUS is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.
Sustained High Blood Pressure with Antidepressant Venlafaxine Extended Release (EFFEXOR XR)
May 2006
If you are taking venlafaxine (Effexor XR)and experience an episode of increased blood pressure you should talk to the prescribing healthcare provider about lowering the dose or stopping the drug.
From Unease to Disease: Redefining Male and Female Sexual Function in the Quest for a Broader Market
May 2006
In comments about the benefit risk ratio of the testosterone patch for women, the question was asked, "Is an increase in approximately one sexually satisfying encounter a month (not from zero to one, but from approximately four to five times per month) worth the possibility of an increase in breast cancer or coronary artery disease?"
Blurring the Boundaries Between Health and Illness
May 2006
The desire to take medicine," wrote Dr. William Osler, "is perhaps the greatest feature which distinguishes man from animals." This desire, however, is neither innate nor stable over time. At present, it is actively promoted by direct-to-consumer advertising on TV and pop-up ads on the Internet as well as by industry-funded disease-awareness campaigns. New diseases may result from new pathogenic agents, of course. But they are most often the result of three deliberate processes: the medicalization of aspects of everyday life (e.g., menopause), the portrayal of mild problems as serious illnesses, and the framing of risk factors (high cholesterol, obesity, osteoporosis) as diseases. The recent issue of PLoS Medicine cited elsewhere illustrates how these processes have affected the diagnosis and treatment of a number of relatively new disease entities
Some Diabetes Drugs May Cause Vision Problems: Rosiglitazone (AVANDIA) and Macular Edema
April 2006
If you experience visual deterioration while taking rosiglitazone (AVANDIA)or the combination of rosiglitazone with metformin (AVANDAMET), report this potential adverse drug reaction to your physician as soon as possible.
A Review of Saw Palmetto in Treating Urinary Symptoms from an Enlarged Prostate
April 2006
Saw Palmetto was found to be no more effective than sugar pills in treating urinary symptoms from an enlarged prostate.
A Review of Amino Acid Dietary Supplement L-Arginine Use After a Heart Attack
April 2006
A study has shown that patients given l-arginine after a certain type of heart attack were more likely to die than similar patients given a placebo (sugar pill).
The Diagnostic Drug Technetium 99m Tc Fanolesomab (NEUTROSPEC) is Banned
April 2006
Mallinckrodt Inc. has agreed to remove the diagnostic drug technetium 99m Tc fanolesomab, a drug to help diagnose appendicitis, from the market because of potentially fatal adverse drug reactions, according to a Dec. 19, 2005 Food and Drug Administration announcement. This is the 17th new drug safety withdrawal since 1992.
Drug Interactions: Updated Information on the Cholesterol Drug Lovastatin (MEVACOR)
April 2006
If you are taking lovastatin to lower your cholesterol and also take any of the 13 drugs discussed in this article, consult with your physician as soon as possible. Dose alterations may be necessary to avoid drug-induced muscle damage.
Drug Ads Fail to Present Risk Information
April 2006
Among the reasons not to trust prescription drug advertising is that the FDA has admitted that 82 percent of drug advertising violations were because inadequate risk information was presented in the ads. The article discusses the importance of using reliable sources for this important information.
FDA Issues Public Health Advisory About Liver Toxicity with the Antibiotic Telithromycin (KETEK)
March 2006
There is no reason to take telithromycin.(KETEK) There are safer and equally effective antibiotics available that are approved to treat the same illnesses. If you or a family member experience the symptoms of potential liver toxicity listed in the article, contact the prescriber immediately. Do not stop taking this antibiotic without an urgent call to your physician so you can be placed on a different, safer antibiotic.
Chronic Kidney Failure Linked to Certain Bowel Cleansing Products Used Prior to Colonoscopy
March 2006
You should talk to your physician prior to a colonoscopy or other procedure that requires a sodium phosphate bowel cleansing drug about the possibility of phosphate-induced kidney toxicity. There are alternative methods of pre-colonoscopy bowel cleansing, discussed in the full article, that are effective but are safer because they do not involve the use of sodium phosphate.
Increased Risk of Blood Clots with the Birth Control Patch Ethinyl Estradiol With Norelgestromin (ORTHO EVRA)
March 2006
Because of the possibility of an increased risk of potentially fatal blood clots with the use of this product, there is no medical reason for women to use the more dangerous Ortho Evra patch rather than one of the older, better understood, and equally or more effective oral contraceptives.
A Warning about AVINZA: Updated Black Box Warning on Extended-Release Morphine Capsules
March 2006
If you are now taking Avinza or Kadian, you should ask your doctor whether another painkiller such as immediate-release morphine might be more appropriate. If you decide to continue taking Avinza or Kadian, you should be sure never to consume alcohol or chew, crush, or dissolve the capsules.
Asthma Drugs Salmeterol (SEREVENT), Salmeterol with Fluticasone (ADVAIR), and Formoterol (FORADIL)
March 2006
The Food and Drug Administration requested that additional new safety warnings be added to the professional product labels for the popular asthma drugs salmeterol (SEREVENT), salmeterol with fluticasone (ADVAIR), and formoterol (FORADIL). The new warnings concern the possibility that these drugs may increase the chance of severe asthma attacks and asthma-related death. DO NOT STOP ANY ASTHMA MEDICATION WITHOUT FIRST CONSULTING YOUR PHYSICIAN. ABRUPTLY STOPPING A MEDICATION MAY RESULT IN ACUTELY DETERIORATING ASTHMA CONTROL.
Increasing Number of Acute Liver Failure Cases Linked to Acetaminophen (TYLENOL)
February 2006
Research published in the December 2005 issue of the medical journal Hepatology found that the annual percentage of potentially fatal acute liver failure (ALF) cases caused by acetaminophen (TYLENOL) rose from 28 percent in 1998 to 51 percent in 2003. The article discusses the problem of alcohol and Tylenol with recommendations.
Antipsychotic Drugs and Dementia in the Elderly
February 2006
Clearly, the concern here is that the use of atypical and typical antipsychotic drugs to control the behavior of elderly nursing home residents who are not psychotic could be considered an unlawful chemical restraint.
Fluoroquinolone Antibiotics Implicated in Life-Threatening Diarrhea
February 2006
Antibiotic-associated diarrhea (AAD) is quite common and its incidence varies from 5% to 20% of patients depending on which antibiotic they are taking. The article lists some of the drugs most associated with this potentially life-threatening adverse reaction.
Serious Blood Sugar Reactions With the Fluoroquinolone Antibiotic Gatifloxacin (TEQUIN)
February 2006
On Dec. 21, 2005, the Canadian equivalent of the Food and Drug Administration (FDA), Health Canada, warned the public and healthcare professionals of serious cases of both low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia) with the use of the fluoroquinolone antibiotic gatifloxacin (TEQUIN).
Diet Drug Poses Risks, Few Benefits
February 2006
On January 23rd, an FDA advisory committee voted to recommend that the agency allow the weight-reduction drug orlistat (Xenical) to be marketed in an over-the-counter form that will be known by the brand name ALLI. However, the drug caused only a minimal increase (4-5 pounds) in weight loss compared to placebo, and studies showed that over time, weight could begin to return. There are also significant safety concerns including the possibility of drug-induced malnutrition and GI effects, including loss of bowel control. The drug is not useful and should not be made over-the-counter.
The Unaffordably High Cost of Cancer Drugs
February 2006
Enter Abstract Here
A Review of Sleeping Pill Ramelteon (ROZEREM)
January 2006
This drug is minimally effective and the long term safety effects of the increased prolactin levels caused by ramelteon are unknown.
Postmenopausal Hormone Replacement Therapy (HRT) and Urinary Incontinence
January 2006
If you are considering starting HRT (hormone replacement therapy), the possibility of experiencing urinary incontinence should be taken into account along with its other potential harms, which are outlined in the black box warning accompanying this article.
Erectile Dysfunction Drugs Can Cause Vision Loss
January 2006
We have asked the Food and Drug Administration (FDA) to add black box warnings to the professional product labels, or package inserts, for the erectile dysfunction drugs sildenafil (VIAGRA), tadalafil (CIALIS), and vardenafil (LEVITRA). The warnings would alert prescribers to the possibility of irreversible vision loss with the use of these drugs.
The New Medicare (Part D) Drug “Benefit”
January 2006
Enter Abstract Here
Safety Alert! Meningitis Vaccine and Serious Nervous System Adverse Reactions
December 2005
Bacterial meningitis is a potentially life threatening condition that is characterized by fever, headache, vomiting, malaise, and a stiff neck. At this time, the FDA and the CDC do not know whether the five cases of Guillain-Barre Syndrome were caused by the Sanofi Pasteur vaccine or were merely coincidental to the administration of the vaccine.
Paxil and Birth Defects
December 2005
You should consult with your doctor immediately if you are taking paroxetine and are pregnant and particularly if you are in your first trimester. Suddenly stopping paroxetine and drugs like it may result in a withdrawal syndrome. See the warning statement above.
Suicide Risk in Youth: Possible Strattera Connection
December 2005
The Food and Drug Administration (FDA) issued a Public Health Advisory on Sept. 29, 2005 to warn of suicidal thinking in children and adolescents being treated with atomoxetine (STRATTERA) for attention deficit hyperactivity disorder (ADHD). There is no convincing evidence that atomoxetine (STRATTERA) is as effective or as well tolerated as stimulants such as methylphenidate (CONCERTA, and others) for treatment of ADHD.
How to Report Adverse Effects from Drugs and Medical Devices to the FDA
December 2005
Product problems should be reported to the FDA when there is a concern about the quality, authenticity, performance, or safety of any drug or device.The article tells how to report to the FDA.
The Cholesterol-Lowering Statin Drugs and Memory Loss
December 2005
In the October 2005 issue of the Canadian Adverse Reaction Newsletter, 19 case reports of memory loss or impairment associated with the use of a cholesterol-lowering statin drug were analyzed. If you are taking a statin drug and you notice memory problems, talk to your doctor about stopping the drug or reducing the dose.
Multivitamins with Minerals: Use in Healthy Older Adults Shows No Benefit
December 2005
Research published in the August 6, 2005 British Medical Journal found that the daily use of a multivitamin with a mineral supplement by people over 65 years of age did not did not affect numbers of infections, use of health care services, quality of life, number of antibiotic prescriptions, or hospital admissions compared to an inactive placebo.
Drivel from the Drug Industry/U.S. Government Axis
December 2005
Enter Abstract Here
Can a Drug Spur Pathological Gambling? Link Seen to Some Drugs Used to Treat Parkinson’s Disease
November 2005
You should contact the prescribing physician as soon as possible if a family member with Parkinson’s disease who is being treated with a dopamine agonist suddenly changes behavior in regards to gambling. (see article for list of drugs)
Echinacea: Not a Cure or Treatment for the Common Cold
November 2005
Echinacea dietary supplements are not more effective than placebo.
Homeopathy: 150 Years Of Failure And Still Going Strong
November 2005
Homeopathy does not provide a useful alternative to conventional medicine. It only provides an alternative method for wasting money on unproven treatments.
Vitamins: Useful or Harmful?
November 2005
Your best source of vitamins is a healthy balanced diet. Use the chart in this article for examples of vitamin-rich foods. Use vitamins only when they are necessary and in consultation with your physician.
Thioridazine (MELLARIL): Sales Halted In Canada
November 2005
The Canadian ban was taken because manufacturers of the drug have failed to provide convincing evidence that thioridazine is safe to use. The questions about safety involve cases of heart rhythm disturbances that can be life-threatening.
Curbing the Influence of the Drug Industry - A British View
November 2005
The committee’s report makes clear that reducing the influence of the industry would be good for everybody, including — paradoxically — the industry itself, which could concentrate on developing new drugs rather than on corrupting doctors, patient organisations, and others.
Antibiotic Clarithromycin (BIAXIN) Can Have Deadly Interaction with Anti-Gout Drug Colchicine
October 2005
Using the antibiotic clarithromycin (BIAXIN, BIAXIN XL) in combination with the gout drug colchicine at the same time increases the risk of death because of colchicine toxicity, a recent study shows. In the 88 patients who received the two drugs together, nine (10.2 percent) died. Only one (3.6 percent) of the 28 patients who received the two drugs sequentially died.
Drug-Induced Car Crashes? Parkinson’s Disease Drugs and the Risk of Sudden Sleep
October 2005
A study appearing in the August 2005 Archives of Neurology provides important new data indicating that the risk of sudden sleep is considerable with certain drugs used to treat Parkinson's Disease(see list in article). You should not drive a car or engage in other potentially dangerous activities unless you have gained sufficient experience from taking any of these drugs while engaged in non-dangerous activities to gauge whether or not you are affected adversely.
Extensive New Warnings for the Potent Pain Drug Fentanyl Transdermal System (DURAGESIC)
October 2005
As the black box warning suggests, fentanyl skin patches should not be used in the following situations:in patients who have not previously been prescribed opioid painkillers, in the management of acute pain or in patients who require opioid pain killers only for a short period of time.
More Dangers From a Toxic Lice Treatment
October 2005
There is no reason why you should use Lindane Lotion or Shampoo when safer and equally effective treatments for lice and scabies are available.
A Review of Alzheimer’s Drugs: Donepezil (ARICEPT), Rivastigmine (EXELON), and Galantamine (REMINYL)
October 2005
This article outlines a recent systematic review of all published, gold standard clinical trials of the Alzheimers disease drugs donepezil (ARICEPT), rivastigmine (EXELON), and galantamine (REMINYL).
Asthma Medicines That Can Cause Asthma Attacks: SEREVENT, ADVAIR and FORADIL
September 2005
Do not stop any asthma medication without first consulting your physician. Abruptly stopping a medication may result in acutely deteriorating asthma control.
BIDIL, a Heart Drug Targeted at African Americans, Stirs Complex Controversy
September 2005
You should only be using BiDil for congestive heart failure in combination with other drugs for this condition. For one-fourth of the cost, with the cooperation of your physician, you can get prescriptions for the two generically-available drugs that comprise BiDil, isosorbide dinitrate and hydralazine.
Birth Control Patch ORTHO EVRA Linked to Dangerous Blood Clots
September 2005
There is evidence that links the popular birth control patch containing a combination of norelgestromin with ethinyl estradiol (ORTHO EVRA) to an increased risk of blood clots and deaths (compared to older contraceptives) in some young healthy women.
When Drinking Alcohol Causes “Dose-Dumping” in a Widely-used Painkiller
September 2005
The Food and Drug Administration (FDA) asked the maker of the long-acting potent narcotic, or opiate, painkiller hydromorphone (PALLADONE) to remove the drug from the market because of a potentially fatal interaction with alcohol. If you are now taking Palladone, Avinza, or Kadian you should talk to your physician immediately to discuss alternative treatment.
The Dark Side of Viagra: Erectile Dysfunction Drugs And Vision Problems
August 2005
You should not use sildenafil Viagra), vardenafil(Levitra), or tadalafil(Cialis) for recreational purposes because there is no medical benefit to be gained. The possible harm from these drugs, no matter how small, will always outweigh a lack of medical benefit. If you experience any visual problems while using these drugs, notify your doctor immediately.
Zoledronic Acid (ZOMETA) And Pamidronate (AREDIA) Linked to Jaw Bone Damage: Popular Osteoporosis Drugs Also Evaluated
August 2005
The FDA Office of Drug Safety recommended that the professional product labeling for alendronate(Fosamax)and risedronate (Actonel) also be revised to warn of the possibility of osteonecrosis of the jaw (destruction of the jawbone). At this time, the FDA has not taken such action.
Aspirin To Prevent Cardiovascular Disease In Women — Is The Picture Any Clearer?
August 2005
If you are healthy, you should not undertake aspirin treatment for the primary prevention of cardiovascular disease without consulting your physician about whether you are at high enough risk to benefit.
Drug Watch — The FDA’s New Drug Safety Web Site
August 2005
Even when fully operational, the site will not be very critical or have very many, if any, of the details about the listed drugs merited by the evidence of their dangers. For this, you will still need to consult the book Worst Pills, Best Pills or our web site www.worstpills.org.
Sleight-of Hand: Merck Tried to Reformulate Vioxx in 2000 While Denying Risk
August 2005
Merck aimed to re-formulate the arthritis drug Vioxx five years ago in order to reduce the potential for heart attacks, adding to previous evidence that the company was fully aware of the dangers of the drug well before it withdrew it from the market last year.
Can I Buy You Dinner? Pharmaceutical Companies Increasingly Use Doctors’ Talks as Sales Pitches
August 2005
"[T]ravel funds, honoraria for minimal consultant visits, lunch for students/residents/faculty, elegant dinners associated with product demonstrations, and guest lecturers with favorable views of donors' products are all suspect. They threaten our integrity and our ability to put patients first in our medical decisions."
Rosuvastatin (CRESTOR) - The Most Dangerous Cholesterol-Lowering Statin Drug
July 2005
Further evidence that Crestor causes uniquely high rates of muscle and kidney damage
FDA Public Health Advisory: Unapproved Use of Atypical Antipsychotics Increases Risk of Death
July 2005
FDA relabels these drugs due to an increased risk of death among patients taking the drugs off-label for dementia.
Weight Loss Supplement Bitter Orange (SYNEPHRINE) Linked to Stroke
July 2005
This dietary supplement, often used as a substitute for ephedra, can cause stroke.
A Review of Eszopiclone (LUNESTA): A Not-So-New Sleeping Pill
July 2005
This drug has no unique benefits, is costly and has caused cancer in an animal study.
Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies
July 2005
How the pharmaceutical industry has turned medical journals into an arm of their marketing operations.
Successfully Pushing Paxil on Television
July 2005
A new study shows how direct-to-consumer advertising can increase the use of antidepressants for minor conditions.
Drug Rep (salesman) vs. Dr. Grobstein
July 2005
How one doctor tried to resist the largesse of the pharmaceutical industry – and how the industry responded.
Serious Skin Reactions with the Seizure Drug Oxcarbazepine (TRILEPTAL)
June 2005
Oxcarbazepine (TRILEPTAL) has been associated with life-threatening skin reactions. If you or a family member develop AN ALLERGIC reaction or a skin rash while taking oxcarbazepine (TRILEPTAL), contact the prescribing physician immediately.
Cholesterol-Lowering Statin Drugs and the Dietary Supplement Coenzyme Q10
June 2005
You should not use coenzyme Q10 in an attempt to prevent or treat the adverse reactions associated with the use of the cholesterol lowering statin drugs.
FDA Public Health Advisory - Arthritis Drug Valdecoxib (BEXTRA) Removed From Market; Major New Warnings for Other NSAIDs
June 2005
If you are currently taking celecoxib (CELEBREX)you should contact your physician to consider alternative NSAID treatment.
A Review of Solifenacin (VESICARE) and Darifenacin (ENABLEX) for Overactive Bladder
May 2005
Both solifenacin or darifenacin are only modestly effective compared to a placebo, both carry the risk of significant harm to older adults, and both are overpriced.
Vitamin E For Cancer And Heart Disease — Enough Is Enough
May 2005
When studied for cardiovascular disease and cancer using the scientific "gold standard" method, a randomized controlled clinical trial, vitamin E offers only a cost without benefit and perhaps some harm.
Public Health Advisory Potential Risk Of Cancer With Eczema Treatments Pimecrolimus (ELIDEL) And Tacrolimus (PROTOPIC)
May 2005
The Food and Drug Administration (FDA) issued a public health advisory on March 10, 2005 to inform patients and healthcare professionals about the potential risk of cancer with the use of two topical drugs, pimecrolimus (ELIDEL) and tacrolimus (PROTOPIC). If pimecrolimus or tacrolimus is the only treatment option for you or a family member for eczema, follow the advice given by the FDA carefully.
REMINDER —The Heartburn Drug Metoclopramide (REGLAN) Can Cause Drug-Induced Movement Disorders
May 2005
The use of the heartburn drug metoclopramide (REGLAN) is increasing and that this fact may result in more cases of drug-induced movement disorders from metoclopramide (Reglan)that in some cases mimic Parkinson. If you or a family member are taking metoclopramide and uncontrollable movements develop, contact the prescribing physician immediately.
FDA-Approved Patient Information For The Heart Drug Amiodarone (CORDARONE) — A Last Choice Drug For Life-Threatening Heart Rhythm Disturbances
April 2005
Amiodarone has several potentially fatal toxicities, the most important of which is lung toxicity. This has resulted in clinically manifest disease at rates as high as 10 to 17 percent in some series of patients. This type of lung toxicity has been fatal about 10 percent of the time.
British To Ban The Combination Painkiller Containing Propoxyphene With Acetaminophen
April 2005
The decision to remove this drug from the market is based on the fact that it is a poor pain reliever and that the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.
NEW BLACK BOX WARNING! Respiratory Depression And Death With The Antinausea Drug Promethazine (PHENERGAN)
April 2005
The warning concerns respiratory depression and death with its use in children less than two years of age. Antinausea drugs are also referred to as antiemetics.
PUBLIC HEALTH ADVISORY Seizures In Patients Without Seizure Disorder Being Treated With Tiagabine (GABITRIL)
April 2005
You should not be taking tiagabine for any use other than treatment of partial seizure. Tiagabine has not been shown to be safe and effective for any use other than treatment of partial seizure.
Deaths Attributed To The Alzheimer’s Disease Drug Galantamine (REMINYL)
March 2005
There is no evidence that this drug leads to substantial functional improvement or prevents the progression of the disease, and new evidence indicates that it may increase the risk of death.
Serious GI Toxicity With The Heart Drug Clopidogrel (PLAVIX)
March 2005
If you are now taking clopidogrel and do not have a severe allergy to aspirin, contact your doctor and discuss switching from clopidogrel to low dose aspirin plus a PPI.
The Cholesterol Lowering Statin Drugs — Not All Have Proven Health Benefits
March 2005
If you must use a statin drug to control your cholesterol, you should use one that has an FDA health benefit claim in its professional product labeling. (chart with these statins listed in the article)
Problems With COX-2 Inhibitors Vault Meloxicam (MOBIC) To Blockbuster Status
March 2005
There is no medical reason why you should be taking meloxicam rather than an older, equally effective NSAID such as ibuprofen to manage arthritis.
Cutting Your Drug Bill While Reducing Your Risk Of Avoidable Adverse Drug Reactions: Six Examples
February 2005
This article will look at the potential savings for the individual consumer if the alternative treatments recommended in Worst Pills, Best Pills were used for six DO NOT USE drugs. All six are listed in the Drug Topics Magazine Top 200 selling drugs in U.S. in 2003. The drugs are: celecoxib (CELEBREX) used for arthritis and pain; the Alzheimer’s disease drug donepezil (ARICEPT); drospirenone with ethinyl estradiol (YASMIN 28), an oral contraceptive; esomeprazole (NEXIUM) the “new purple pill” for heartburn; montelukast (SINGULAIR), a drug approved for both asthma and hay fever; and valdecoxib (BEXTRA), an arthritis drug very similar to celecoxib.The combined sales of these six DO NOT USE drugs was $8.1 billion with more that 75 million prescriptions dispensed in 2003.
Liver Toxicity With New ADHD Drug Atomoxetine (STRATTERA)
February 2005
On December 17, 2004 the Food and Drug Administration (FDA) issued a new warning for atomoxetine (STRATTERA), a drug approved to treat attention deficit hyperactivity disorder (ADHD) in adults and children, to include a bolded warning about the potential for severe liver toxicity.
Black Box Warning For The Injectable Contraceptive Medroxyprogesterone Acetate (DEPO-PROVERA)
February 2005
The Food and Drug Administration (FDA) announced on November 17, 2004 that a black box warning is now required in the professional product labeling, or package insert, for the widely prescribed injectable long-term contraceptive medroxyprogesterone acetate (DEPO-PROVERA).
Duloxetine (CYMBALTA) for Major Depressive Disorder - Nothing Special and Possible Liver Toxicity
January 2005
An FDA reviewer wrote: In the event that unconfounded cases of severe liver injury or acute liver failure related to duloxetine treatment are identified and submitted early in the postmarketing period, the division will use the threshold of three “clean” cases to initiate additional regulatory action that could range from a more prominent warning to the withdrawal of the drug product.
Revisiting Clopidogrel (PLAVIX) Plain Aspirin Still Preferred in Preventing Stroke, Heart Attack and Blood Clots
January 2005
If you have had a previous heart attack, stroke, or have blood vessel disease you should be on aspirin treatment rather than clopidogrel unless you cannot tolerate aspirin, or aspirin treatment has failed. If you are now taking ticlopidine and cannot take aspirin, talk to your doctor about clopidogrel.
Reporting Adverse Events With Drugs and Medical Devices to the Food and Drug Administration
January 2005
The FDA offers several ways for health professionals or consumers to submit MedWatch reports: Online — Go to the MedWatch Web site at www.fda.gov/medwatch/ and follow the instructions for submitting a report electronically By mail — Fill out and mail the MedWatch form on the next page to the FDA By phone — The toll-free number for reporting to the FDA is 1-800-FDA-1088
A Review of Ezetimibe (ZETIA) and Ezetimibe with Simvastatin (VYTORIN) For Cholesterol Lowering
December 2004
We are concerned about any new drug but are particularly concerned about the use of ZETIA together with statins.
Reporting Rate For Kidney Damage Is 75 Times Higher With Crestor (Rosuvastatin)
December 2004
The letter was prompted by a new Public Citizen analysis of adverse drug reaction reports to the FDA. The analysis found that the rate of reports of kidney failure or damage among patients taking Crestor is 75 times higher than in all patients taking all other statin drugs.
Black Box Warning To Be Required On All Antidepressants Concerning Suicide Risk In Children And Adolescents
December 2004
Belatedly, the Food and Drug Administration (FDA) announced on October 15, 2004 that it is taking steps to inform parents and physicians about the risks of antidepressants when these drugs are used to treat major depressive disorder in children and adolescents.
Drug Induced Peripheral Neuropathy From The Fluroquinolone Antibiotics
December 2004
The Food and Drug Administration (FDA) now requires that the professional product labeling, or package inserts, for all fluroquinolone antibiotics must warn about the possibility of peripheral neuropathy (nerve damage). A list of the fluroquinolone antibiotics currently available in the U.S. appears at the end of this article.
Manufacturer Finally Admits Heart Risks With The Arthritis Drug Valdecoxib (BEXTRA)
December 2004
People now taking Bextra should contact their doctors to discuss heart risks of this drug.
Blockbuster Arthritis Drug Rofecoxib (VIOXX) Withdrawn From Market
November 2004
Vioxx is the ninth prescription drug to be taken off the market in the past seven years that Worst Pills, Best Pills News readers were previously warned DO NOT USE. The average time between warning readers not to use these drugs and their removal from the market was one year and eight months.
The Widely Used Antibiotic Erythromycin And Fatal Heart Rhythm Disturbances
November 2004
You should not take erythromycin in combination with one of the interacting drugs listed in this article. If you are, you should contact your physician immediately. As mentioned above, erythromycin is an important antibiotic when used appropriately. Therefore, we do not recommend against its use when it is not used with one of these interacting drugs.
Probiotic (Friendly Bacteria) Lactobacillus Does Not Prevent Vaginal Yeast Infections After Antibiotic Treatment In Women
November 2004
The use of lactobacillus in post-antibiotic vulvovaginitis is an example of a treatment that has widespread use despite lack of a biologically plausible basis or evidence of effectiveness.
A Review of Trospium (SANCTURA) for Overactive Bladder
November 2004
Trospium appears to offer no advantage over long-acting anticholinergics for treatment of overactive bladder, and its poor absorption from the gastrointestinal tract could be problematic.
Tiotropium (SPIRIVA) for Chronic Obstructive Pulmonary Disease (COPD). Is it an Important Advance?
October 2004
If you are now using ipratropium for breathing problems as a result of COPD, you may wish to switch to tiotropium. This would reduce the number of times per day you must use a drug from four to one, although there is a substantial cost associated.
A Review of Irritable Bowel Syndrome Drug Tegaserod (ZELNORM) Now Approved for Chronic Constipation
October 2004
Novartis Pharma announced on August 24, 2004 that its drug tegaserod (ZELNORM) had been approved by the Food and Drug Administration (FDA) to treat chronic constipation in both males and females less than 65 years old.
Drugs That Can Cause Headache From Their Overuse
October 2004
A high frequency of drug intake to manage headache pain may mean that you have a condition known as medication overuse headache (MOH). According to the International Headache Society, MOH may exist when the following criteria are fulfilled: (1) there is headache on 15 or more days a month; (2) pain characteristics are dull, and of light to moderate intensity on both sides of the head; (3) drug intake includes ergots, triptans and opioids (these drugs are discussed below) for 10 or more days per month, simple painkillers 15 days or more for a minimum of 3 months; and (4) the headache disappears after withdrawal.
Canadians Warned of Potential Adverse Effects of Maternal Use of Antidepressants on Newborns. American Mothers Still in the Dark
October 2004
The Canadian equivalent of the Food and Drug Administration (FDA), Health Canada, issued a public advisory on August 9, 2004 warning that newborns may be adversely affected when their mothers take one of the family of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) and other newer anti-depressants during the third trimester of pregnancy.
Lawsuit Reveals Serious Safety Problems with the Nonsteroidal Anti-inflammatory Drug Valdecoxib (BEXTRA)
September 2004
Public Citizen filed suit in the District Court for the District of Columbia on February 25, 2004 against the Food and Drug Administration (FDA) asking that they make public complete copies of the agency’s scientific reviews of the nonsteroidal anti-inflammatory drug (NSAID) valdecoxib (BEXTRA).
A Review of Long-Term Treatment With the Alzheimer's Disease Drug Donepezil (ARICEPT) Ineffective
September 2004
There is a lack of evidence that this drug provides any meaningful benefit to Alzheimer’s disease patients.
Drug Interaction Reminder: Fluoroquinolone Antibiotics and the Anticoagulant (Blood Thinner) Warfarin (COUMADIN)
September 2004
You should consider that all fluoroquinolone antibiotics have the potential to interact with warfarin and your physician should be ordering blood tests to monitor the status of your blood clotting if one of these antibiotics is needed and you are using warfarin. This is the safest thing to do.
Why is the U.S. So Far Behind on Prescription Drug Price Controls?
September 2004
Whereas Germany has rejected the idea that the pharmaceutical industry, with its extraordinarily high profit margin, does not have enough money to develop drugs even with controls on prices, we are far behind in the U.S. One crucial difference is the power of the drug lobby in Washington: There are more pharmaceutical industry lobbyists in Washington than there are members of congress.
Suicide Risk Added To The Professional Product Labeling For Eight Antidepressants
August 2004
At the request of the Food and Drug Administration (FDA), eight out of ten manufacturers of newer antidepressants have agreed to add a warning about the possibility of an increased risk of suicide associated with the use of these drugs. The warning will appear in the professional product labeling, or package insert, for these drugs.(listed in the article)
Food and Drug Administration Warns Against The Use Of The Unapproved Drug Domperidone To Increase Milk Production
August 2004
The FDA recognizes the immense health benefits that breast milk provides for a nursing infant and is taking these actions today not to discourage women from breastfeeding but rather to warn them not to use this particular drug while they are breastfeeding.
Protecting Profits: Amlodipine With Atorvastatin (CADUET) For High Blood Pressure And High Cholesterol
August 2004
We can think of no medical reason why you should be taking Caduet unless you are being treated satisfactorily with doses of amlodipine and atorvastatin that are available as Caduet. If you have not been tried on more effective drugs for high blood pressure such as diuretics or beta-blockers, amlodipine is a poor choice.
Dextromethorphan (DELSYM or generic) Or Diphenhydramine (BENADRYL or generic) Ineffective For Nighttime Cough In Children
August 2004
Neither dextromethorphan or diphenhydramine is effective and each has its own risks.
New Drug Interaction Warnings For The Antidepressant Trazodone (DESYREL)
August 2004
In May 2004, the Food and Drug Administration (FDA) announced that new drug interaction warnings are now required in the professional product labeling or package insert for the antidepressant trazodone (DESYREL). Health Canada, the Canadian drug regulatory authority, announced similar warnings for the drug on July 9, 2004. This article lists those drugs that interact with trazodone.
The People Have Spoken: The Drug Industry Doesn’t Serve Us Well
August 2004
Back in the industry’s salad days in 1997, a full 79% of those surveyed professed a favorable attitude toward the drug companies. But since then the industry has experienced a downward spiral, losing support every year but one. The 35% drop in its favorable rating between 1997 and 2004 is a larger drop than every other industry, although the managed care (-21%) and health insurance industries (-19%) were in hot pursuit.
Drugs for Alzheimer's Disease
July 2004
Although, according to the New York Times, “a million Americans take them, at an overall cost of $1.2 billion a year.”, a professor at Johns Hopkins University School of Medicine who is an expert in Alzheimer’s disease was quoted in the article and placed the value of the current crop of Alzheimer’s drugs in perspective when he said, “You can name 11 fruits in a minute instead of 10. Is that worth 120 bucks a month?”
A Review of Memantine (NAMENDA) for Alzheimer’s Disease
July 2004
Memantine (NAMENDA) is the first drug approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe Alzheimer’s disease dementia.
Update on Weight Loss Drug Sibutramine (MERIDIA)
July 2004
A new study shows that there is no direct evidence that sibutramine reduces obesity-associated morbidity or mortality and that there is insufficient evidence to accurately determine the risk-benefit profile for sibutramine.
It Takes Two to Tango (or to Bribe): Big-Time Crime in the Pharmaceutical Industry with the Help of Doctors
July 2004
Instead of patients being prescribed the safest, most effective, least expensive drugs, the prescribing decision is distorted by golf, money, and other kinds of inducements by those doctors who are willing to be bribed. If the prescription involves a patient whose prescription is being paid for by Medicaid or Medicare, it is illegal for doctors to accept anything of value in exchange for prescribing a particular drug.
Nerve Damage: Another Serious Adverse Effect of Leflunomide (ARAVA)
July 2004
FDA scientists reviewed 80 patients who developed nerve damage, mostly involving sensation but, in some cases, involving motor function (weakness) in the arms or legs after using ARAVA.
The Wild, Wild Web for Prescription Drugs
July 2004
The U.S. government, at least, seems to suspect that illegal activity is rife in this industry. Fourteen of the 68 pharmacies (nine U.S., one Canadian and four other foreign countries) were under investigation by either the U.S. FDA or the Drug Enforcement Administration for allegations of selling controlled substances without a prescription, lack of a doctor-patient relationship, selling adulterated or counterfeit drugs, smuggling, mail fraud, etc.
Improper Antibiotic Treatment for Bladder Infections
June 2004
In a recent study of more than 13,000 women going to a doctor because of a bladder infection, more than 95% of whom had an acute bladder infection (not a recurrent one), only 37% were prescribed the preferred treatment for this condition:
Serious and Growing Problem of Antibiotic Resistance
June 2004
In a current campaign to educate doctors and the public about the seriousness of the problem of antibacterial resistance, the Federal Centers for Disease Control, part of the Department of Health and Human Services, has published these worrisome statistics: Each year nearly 2 million patients in the United States get an infection in a hospital. Of those patients, about 90,000 die as a result of their infection. They recommend avoiding unnecessary use of antibiotics or the wrong antibiotic and list, for patients, principles to follow.
A Review of New Antibiotic Telithromycin (KETEK)
June 2004
Telithromycin (KETEK) has shown to be no more effective than other antibiotics: amoxicillin, cefuroxime, clarithromycin, and trovafloxacin.
Dangerous Antidepressant Nefazodone (SERZONE) Now Withdrawn From the Market in Europe, Canada, Australia and New Zealand
June 2004
In March, 2003 Public Citizen’s Health Research Group first petitioned the FDA to ban this uniquely dangerous antidepressant because of liver toxicity (see Worst Pills, Best Pills News March 2003).  As the toll of liver damage and death continued to rise, we amended our petition (see Worst Pills, Best  Pills News December 2003) and in March of this year we filed a lawsuit in U.S. District Court for the District of Columbia against the FDA because they had failed to act on our petition.
CBS Evening News on Serzone: New Concerns Over Anti-Depressant
June 2004
On April 15th of this year, the CBS Evening News asked Dr. Sidney Wolfe of Public Citizen "Is there any legitimate reason this drug should still be sold in the U.S. when it’s been taken off the market in other places for the same dangers?" Dr. Wolfe replied, "From a financial perspective, the only reason is to make money for Bristol Myers Squibb. But from a health perspective there is no justification for this drug being on the market."
Dangerous Drug for Irritable Bowel Syndrome: Constipation-Predominant Tegaserod (ZELNORM)
June 2004
Tegaserod (ZELNORM) is a potentially dangerous drug of minimal efficacy used in the treatment of a non-life threatening condition.
Aspirin and Heart Attacks: Secondary Prevention, Yes; Primary Prevention, No
May 2004
Aspirin is the preferred preventive treatment for those who have already had a heart attack (secondary prevention), at least for the majority of people who are not intolerant to aspirin. However, the lack of evidence of an aspirin benefit in the primary prevention of heart attack is clearly outweighed by the increased risk of bleeding from aspirin, and you should not use aspirin for the primary prevention of heart attacks.
The Newer Atypical Antipsychotic Drug Olanzapine (ZYPREXA) Shows No Advantage Over Haloperidol (HALDOL)
May 2004
A randomized controlled clinical trial, the “gold standard” for scientific research, published in the November 26, 2003 Journal of the American Medical Association (JAMA) compared the newer top selling atypical antipsychotic drug olanzapine (ZYPREXA) to the much older antipsychotic agent haloperidol (HALDOL) and concluded that this trial: "...found no statistically or clinically significant advantages of olanzapine for schizophrenia on measures of compliance, symptoms, or overall quality of life, nor did it find evidence of reduced inpatient use or total cost."
The Antidepressant Fluoxetine (Prozac) and Suicidal Ideation — Déjà vu 1991
May 2004
Fourteen years ago, in May 1991, the Health Research Group petitioned the Food and Drug Administration (FDA) to require a warning in the professional product labeling, or package insert, of fluoxetine (PROZAC) concerning the risk of suicidal impulses in patients using the drug. Fluoxetine belongs to the family of antidepressants known as selective serotonin re-uptake inhibitors, or SSRIs. Read the warning we asked for back then.
Saline Spray: Do Try This at Home
May 2004
As spring approaches, it brings with it flowers, pollen, and allergies. While there are a plethora of over-the-counter and prescription medications for symptomatic relief of allergic symptoms, sometimes the simplest solutions are the most effective. Discusses "recipe" for making saline nasal spray.
Pharmaceutical Companies Offer Doctors Free Trips, Gifts for Prescriptions
May 2004
After successful criminal prosecution of drug companies for bribing doctors, rhepharmaceutical industry has strengthened its voluntary guidelines on gifts to doctors, which now are not supposed to exceed $100 in value. Dr. Sidney Wolfe of the Public Citizen Health Research Group in Washington told ABC News that despite these guidelines, “We have evidence since those guidelines went into effect of doctors being offered $1,500 to be a ‘consultant’— translated into English, so that the company can convince that doctor to prescribe their drug.”
Why is the U.S. So Far Behind on Prescription Drug Price Controls?
May 2004
Largely because there are more pharmaceutical industry lobbyists in Washington than there are members of congress, the idea of having price controls in the Medicare prescription drug benefit law that just was passed—-so that the drugs could actually be affordable—-was quickly killed. Details about other countries are discussed.
Publicity about Recent Studies on the Cholesterol-lowering Statin Drugs: Misinterpretations
April 2004
There has been an extraordinary amount of news attention focused on recent studies concerning statins and heart disease, presented at the American College of Cardiology meetings in March and, in one case, published in the April 8, 2004 New England Journal of Medicine.This article discusses several specific ways in which industry-spun news coverage has misrepresented the facts about this issue.
The Inappropriate Prescribing of the Acne Drug Isotretinoin (ACCUTANE) Continues
April 2004
Public Citizen’s Health Research Group has been warning the FDA about the risks of birth defects and mental retardation for fetuses exposed to isotretinoin (ACCUTANE) for over 20 years. This article contains the history of these efforts and warns that you or your children should use isotretinoin only in the case of severe recalcitrant nodular acne after other safer acne treatments have been tried and failed. Exposure of an unborn fetus to isotretinoin is a serious adverse event and should be reported directly to the FDA Med Watch Program along with other adverse reactions.
Updates: Rosuvastatin (CRESTOR) and Nefazodone (SERZONE)
April 2004
This article discusses why there is no medical reason that you or a family member should be taking either rosuvastatin or the anti-depressant nefazodone.
Direct-to-Consumer Advertising: Bad News for Most Patients and Doctors
April 2004
A recent study of patients and doctors has found that most people in both groups have very negative views about the impact of prescription drug direct-to-consumer (DTC) advertising campaigns, now costing the public — which ultimately pays for the campaigns — about $3 billion a year. The study, published in the Archives of Internal Medicine in February, examined the attitudes of 784 doctors, in Colorado and nationally, and 500 Colorado households about many issues concerning DTC advertising.
Prescription Drug Ads and High Drug Prices: A Relationship?
April 2004
According to a supplement put out by Advertising Age in March entitled Fact Pack 2004 Edition, with additional information taken from Ad Age’s web site, the pharmaceutical industry continues to be quite adept at maintaining its place among the leading advertisers. Four of the top 25 U.S. advertisers, in terms of spending in this country during 2002, were drug companies. The article urges that you do not waste your time looking at or listening to prescription (or over-the-counter) drug ads.
Further Updates on the Cholesterol-Lowering Statin Drug Rosuvastatin (CRESTOR)
March 2004
We have obtained new information about serious post-marketing adverse reactions — rhabdomyolysis and kidney failure — caused by the recently-approved cholesterol-lowering “statin” drug rosuvastatin (Crestor-AstraZeneca) and have also become aware of decisions by major U.S.health insurors not to reimburse for it.
Overselling Donepezil (ARICEPT) and Exploiting Patients with Alzheimers Disease: Why Isn't the FDA Stopping These Ads?
March 2004
A highly misleading advertisement for ARICEPT, implying the drug could keep patients with Alzheimers Disease from having to go into a nursing home for two years, was allowed to run for a very long time without being stopped by the FDA.
Arthritis Drug Leflunomide (ARAVA) Linked to Japanese Deaths from Lung Disease
March 2004
Aventis, manufacturer of the widely prescribed arthritis drug leflunomide (ARAVA) said that five Japanese patients have died from a drug-induced lung condition after taking its drug to treat arthritis and that it has asked doctors to take further precautions before prescribing the medication.
FDA Updates Hormone Therapy (HRT) Information for Post-Menopausal Women: HRT Causes Dementia
March 2004
In a 1991 book, Women's Health Alert, we warned that "Female replacement hormones may someday be remembered as the most recklessly prescribed and dangerous drugs of this century." Now, a new study shows that that women using Prempro, a combination of estrogen and progesterone as hormone replacement therapy, were twice as likely to suffer from demetia as women getting a placebo.
The FDA Finally Bans Ephedra
February 2004
Once again, Worst Pills, Best Pills readers were warned about the dangers of a drug well before — in this case two and one-half years before — the government got around to a ban.
Grapefruit Juice and Prescription Drugs: Some Dangerous Interactions
February 2004
The January 5th issue of the Medical Letter, a widely respected source of independent information about pharmaceuticals and dietary supplements, has a review of the increasingly researched problem of the interaction between grapefruit juice and many prescription and over-the-counter drugs. Like most interactions between chemicals in the body, this one involves the impairment, by grapefruit juice, of the body’s ability to metabolize many drugs, leading to higher than expected — and sometimes dangerous — levels of these drugs.This article lists the drugs.
A Review of Seizure Medication Topiramate (TOPAMAX) for Weight Reduction
February 2004
Internet advertisements are heavily promoting the use of topiramate (TOPAMAX), a prescription drug approved by the FDA only for the treatment of seizures, as a weight reduction agent, a purpose for which it has not been shown to be safe and effective.
Pergolid Mesylate (PERMAX): Warning About Falling Asleep and Auto Accidents
February 2004
On December 22nd, FDA and Lilly modified the label for pergolid mesylate (PERMAX), a drug used in the treatment of Parkinson’s disease, and informed healthcare professionals of the possibility of patients falling asleep while performing daily activities, including operation of motor vehicles, while receiving treatment with pergolid mesylate. Although the patient information in the revised label does not mention auto accidents, the professional information, printed below, does.
Harlot: How to Achieve positive Results without actually Lying to Overcome the Truth
February 2004
The Editor of the British Medical Journal writes about how the acronym for the above title, HARLOT, means what it says.
Canada Outdoes U.S. on Flu Vaccine Policy
February 2004
We have all seen pictures on the news of people waiting in long lines to get their flu shots this year; many of us were not able to get one before the supply ran out. Because the Canadians have taught us a thing or two about how to run a national health insurance system, we decided to look to our neighbors north of the border to see how they handle their flu shots.
A Review of Two More Drugs For Erectile Dysfunction: Vardenafil (LEVITRA) And Tadalifil (CIALIS)
January 2004
You should wait at least seven years from the date of release to take any new drug unless it is one of those rare “breakthrough” drugs that offers you a documented therapeutic advantage over older proven drugs.
New Warnings About Fatal Liver Toxicity And Infections For The Arthritis Drug Leflunomide (ARAVA)
January 2004
The maker of the arthritis drug leflunomide (ARAVA), Aventis Pharmaceuticals of Bridgewater, NJ, notified health professionals in October 2003 that new safety warnings concerning life-threatening liver toxicity and infections have been required on the professional product labeling or package insert for the drug.
DO NOT USE UNTIL 2011 Eplerenone (INSPRA) For High Blood Pressure
December 2003
This statement appears in the professional product labeling, or package insert, for eplerenone: “The principal risk of INSPRA is hyperkalemia. Hyperkalemia can cause serious, sometimes fatal, arrhythmias (heart rhythm disturbances).”
FDA Issues Public Health Advisory On Antidepressants And Suicide Risk In Children
December 2003
The Food and Drug Administration (FDA) issued a Public Health Advisory on October 27, 2003 about reports of suicidal thinking and suicide attempts in clinical trials of eight drugs in pediatric patients with major depressive disorder (MDD).
DO NOT USE! Dangerous Antidepressant Nefazodone (SERZONE) Withdrawn From The Market In Canada HRG Files Second Petition to Ban Nefazadone
December 2003
Nefazodone (SERZONE), a dangerous antidepressant long linked to liver toxicity and deaths, was withdrawn from the Canadian market effective November 27, 2003. The drug is produced by Bristol-Myers Squibb in both Canada and the U.S.
How To Report Adverse Reactions To The FDA
December 2003
Consumers can play an important public health role by reporting any adverse experiences with drugs, devices, or dietary and herbal supplements to the Food and Drug Administration (FDA). This can be done through the MedWatch program, the FDA’s medical products reporting system. The article gives information on reporting these adverse reactions.
DO NOT USE! Asthma Drug Montelukast (SINGULAIR) For The Treatment Of Hay Fever
November 2003
The Food and Drug Administration (FDA), on January 23, 2003, approved the asthma drug montelukast (SINGULAIR) for the relief of symptoms of seasonal allergic rhinitis (hay fever) in adults and children two years of age and older. Montelukast is a member of a family of drugs known as leukotriene inhibitors.You should not use montelukast for the treatment of hay fever symptoms because of its meager effectiveness and exorbitant cost.
Another Drug Safety Withdrawal - The Opioid Dependence Drug Levomethadyl (ORLAAM)
November 2003
Ten cases of life-threatening heart rhythm disturbances associated with the use of levomethadyl have been reported to European authorities since July 1, 1997.
DO NOT USE! Strong New Safety Warning Added For The Asthma Inhaler Salmeterol (SEREVENT)
November 2003
DO NOT STOP ANY ASTHMA MEDICATION WITHOUT FIRST CONSULTING YOUR PHYSICIAN. ABRUPTLY STOPPING A MEDICATION MAY RESULT IN ACUTELY DETERIORATING ASTHMA CONTROL. In the March 2003 Worst Pills, Best Pills News we listed the asthma drug salmeterol (SEREVENT) as a DO NOT USE drug after the Food and Drug Administration (FDA) announced on January 23, 2003 that a large safety study involving the drug had been halted prematurely because an interim analysis of outcomes suggested that the drug may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths.
A Reminder About The Dangers Of Aspirin And Reye’s Syndrome
November 2003
Warnings: Reye’s syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.
Reducing The Risk Of Hip Fracture -— Another Benefit Of The High Blood Pressure-Lowering Water Pills (Thiazide Diuretics)
November 2003
Research published in the September 2003 issue of the Annals of Internal Medicine provides more supportive evidence that the high blood pressure-lowering thiazide diuretics, or water pills, may protect against hip fractures.
Advertising Dietary Supplements on the Internet: Supplementing Income Rather than Health
November 2003
In retrospect, it all seems so predictable. Put an unregulated industry hawking largely ineffective or unproven products on a free-wheeling medium, and false claims are sure to proliferate.
Outrage: We Have Met the Enemy and He is Us
November 2003
FDA’s announcement on September 9 of a “Collaborative Campaign to Inform Women About Menopausal Hormone Therapy” sounded as though it might hold some promise; that is, until you actually went to the Collaborative Campaign web site Instead of the dry, fact-filled explanation of the risks and benefits of HRT one might expect from the FDA, the opening page on the site contained no substantive information whatsoever.
Do Not Use! Rosuvastatin (Crestor) - A New But More Dangerous Cholesterol Lowering 'Statin' Drug
October 2003
Rosuvastatin (CRESTOR) became the sixth cholesterol lowering "statin" drug on the U.S. There is no medical reason for you to be taking rosuvastatin when there are three safer and more effective statins, in terms of reducing cardiovascular events, on the market.
Important New Warnings! The Use Of The Antidepressant Venlafaxine (EFFEXOR, EFFEXOR XR) In Children And Adolescents
October 2003
Parents whose children are taking venlafaxine should consult the prescribing physician immediately. DO NOT stop venlafaxine treatment immediately. Discontinuation of this drug requires medical supervision.
Over-The-Counter Omeprazole (PRILOSEC OTC) — There Are Better Choices For Heartburn
October 2003
You should try the non-pharmacologic interventions listed in the box below before trying antacids, histamine-2 blockers, or, as a last resort, proton pump inhibitors. If you classify yourself as a person with frequent heartburn, that is heartburn more than two days per week, and the interventions recommended above have failed, you should be under the care of a physician
Meridia — Weight Loss or Health Loss?
October 2003
Against the better judgment of both the physicians who reviewed the data for the Food and Drug Administration (FDA) and the FDA’s external Advisory Committee, the weight loss drug Meridia (sibutramine) has been on the market for over five years. Both the agency’s own doctors and its advisors are on record as saying that the benefits (loss of a few pounds in weight) do not outweigh the risks (increased blood pressure and thus increased risk for heart attack and stroke).
Outrage: Food and Drug Disaster
October 2003
This article, by Health Letter Editor Sidney Wolfe, appeared on September 10, 2003 on the editorial page of the Washington Post. With gusto, Food and Drug Administration Commissioner Mark McClellan has promoted, in speeches and press releases, one of his priorities: increasing the amount of accurate information conveyed to consumers about FDA-regulated products. “I consider it a public health hazard when people are misled by false claims,” he said recently.
A Reminder About The Dangers of Aspirin and Reyes's Syndrome
October 2003
Children and teenagers should not use aspirin when they have the flu.
Severe Neuropsychiatric Adverse Effects Associated With The Antimalarial Drug Mefloquine (LARIAM)
September 2003
Tell your physician not to prescribe mefloquine if you or someone you know has a history of psychiatric disturbances or convulsions. If mefloquine is prescribed, care should be exercised with regard to driving and operating machines since dizziness, a disturbed sense of balance, and other neuropsychiatric effects have been associated with this drug.
Dangerous, Inappropriate Prescribing Of Diabetes Drugs Metformin (GLUCOPHAGE), Rosiglitazone (AVANDIA), And Pioglitazone (ACTOS) To Patients With Heart Failure
September 2003
Government-sponsored research published in the July 2, 2003 Journal of the American Medical Association found that the diabetes drugs metformin (GLUCOPHAGE), rosiglitazone (AVANDIA), and pioglitazone (ACTOS) were being prescribed inappropriately to patients with heart failure and that the inappropriate prescribing of these drugs has been increasing over time.
The Serotonin Syndrome: A Potentially Life-Threatening Adverse Drug Reaction — Fluoxetine (PROZAC), Escitalopram (LEXAPRO), Sibutramine (MERIDIA) And Other Drugs
September 2003
Canadian drug regulatory authorities reviewed reported cases of serotonin syndrome in the July 2003 issue of the Canadian Adverse Reaction Newsletter. The serotonin syndrome is a potentially life-threatening adverse drug reaction involving an excess of serotonin, a naturally occurring nerve transmitter.
Drug-Induced Taste Disorders
September 2003
DO NOT stop taking any of the drugs listed in the table without first consulting your physician. You should report any alteration in your sense of taste to your physician if you are taking a drug.
New Warnings For The Seizure Drug Topiramate (TOPAMAX)
September 2003
A warning was issued in June 2003 about the possibility of potentially serious decreased sweating (oligohidrosis) and elevated body temperature (hyperthermia) with the use of the seizure medication topiramate (TOPAMAX). Topiramate is approved by the Food and Drug Administration (FDA) for adult and child patients ages two to 16 years with certain types of seizures, and in patients two years of age and older with seizures associated with Lennox-Gastaut syndrome.
Do Not Use Finasteride (PROSCAR, PROPECIA) For Preventing Prostate Cancer
August 2003
The results of the study were mixed, with the increased risk of high-grade cancer caused by the drug outweighing the decreased risk of cancers that may be of little clinical significance.
FDA Issues Safety Advisory Recommending Against Use Of Selective Serotonin Re-Uptake Inhibitor (SSRI) Antidepressant Paroxetine (PAXIL) In Children
August 2003
On June 19, 2003, the Food and Drug Administration (FDA) issued a public advisory concerning the safety of paroxetine (PAXIL), a member of the selective serotonin re-uptake inhibitor (SSRI) family of antidepressants, in children or adolescents less than 18 years of age. The advisory is based on reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents under the age of 18 taking paroxetine for major depressive disorder (MDD). This was based on reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents under the age of 18 taking paroxetine for major depressive disorder (MDD).
Seizure Medication Lamotrigine (LAMICTAL) Approved For Use In Bipolar Disorder
August 2003
GlaxoSmithKline of Research Triangle Park, NC announced in June 2003 that their seizure medication lamotrigine (LAMICTAL) had been approved by the Food and Drug Administration (FDA) for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes such as depression, mania (periods of severe highs), hypomania, or mixed episodes in patients also being treated with standard therapy. If you make the decision to use lamotrigine for bipolar I disorder and if a rash appears, report it to your physician immediately and the drug should be discontinued.
NEW DRUG INTERACTION WARNING! Repaglinide (PRANDIN) For Diabetes And The Cholesterol Lowering Drug Gemfibrozil (LOPID)
August 2003
The European Agency for the Evaluation of Medicinal Products (EMEA) issued a public warning on May 21, 2003 not to use the combination of repaglinide (PRANDIN), a drug for lowering blood sugar in type-2 diabetics, and the cholesterol drug gemfibrozil (LOPID). The warning was based on a recent publication in the March 2003 issue of the medical journal Diabetologia that found the use of these two drugs in combination can enhance the blood sugar lowering effects of repaglinide and can thereby result in severe blood sugar lowering (hypoglycemia).
DO NOT USE! Esterified Estrogens With Methyltestosterone (ESTRATEST and ESTRATEST HS) For Hot Flashes
August 2003
On April 10, 2003, the Food and Drug Administration (FDA) announced that it was beginning legal procedures to remove the marketing authorizations for combination drug products containing estrogen and androgen, female and male hormones respectively. Estrogen and androgen combination products had been approved for the treatment of moderate to severe “hot flashes” (vasomotor symptoms) associated with the menopause in women whose symptoms were not improved by estrogen alone. We agree with the FDA’s decision to remove the marketing authorizations for combination drug products containing estrogen and androgen; however, the issue over the effectiveness of these combinations goes back for decades and this action by the FDA is long overdue.
Profitably Inventing New Diseases
August 2003
A recent article in Medical Marketing and Media (May 2003), aimed at the marketing departments of the pharmaceutical industry, provides an extraordinary view of this industry of which the public, unfortunately, remains unaware. Vince Parry, the “Chief Branding Officer” for a company called “InChord,” tells his pharmaceutical company readers — and potential clients — how to increase sales by combining the “creation” of a disease with a drug to treat it.
Taxol: How the NIH Gave Away the Store
August 2003
It is fair to say that without the NIH there would have been no Taxol. The agency identified a component of the Pacific Yew as having anti-tumor activity as long ago as 1963 and identified the chemical responsible for this activity back in 1971. In 1983, the NIH began the first of several clinical trials of Taxol; BMS was essentially absent from the scene until it signed a CRADA with the NIH in 1991.
Oxybutynin Patches (OXYTROL): A Grossly Overpriced Product For Overactive Bladder
July 2003
You should check the list of drugs that can cause loss of bladder control before starting drug treatment for this condition. You may be able to change from a drug that causes loss of bladder control to a drug that does not or alter the dose. This may be enough to solve the problem.
Heart Failure After Treatment With Etanercept (ENBREL) and Infliximab (REMICADE) - Drugs Used For Rheumatoid Arthritis and Crohn's Disease
July 2003
Staff from the Food and Drug Administration (FDA) and the Duke Clinical Research Institute reviewed 47 cases of heart failure, reported the FDA’s adverse drug reaction reporting system associated with the use of the drugs etanercept (ENBREL) and infliximab (REMICADE), and the results were published in the May 20, 2003 issue of Annals of Internal Medicine.
Inappropriate Prescribing Of Fluoroquinolone Antibiotics, Ciprofloxacin (CIPRO), Gatifloxacin (TEQUIN), And Others
July 2003
In this study, the researchers evaluated 100 consecutive patients who went to the emergency room and received a prescription for a fluoroquinolone antibiotic. Of the 100 patients, 81 (81%) received a fluoroquinolone antibiotic for an inappropriate use. In 43 (53%) of these patients, a fluoroquinolone was found inappropriate because another antibiotic was considered first-line treatment, and in 27 (33%) patients there was no evidence of an infection and therefore no indication for the use of any antibiotic.
Do Not Use Until December 2009 The New Antipsychotic Drug Aripiprazole (ABILIFY)
June 2003
You should follow the Health Research Group’s Seven Year Rule with aripiprazole. There is no evidence to suggest that aripiprazole is a “breakthrough” drug.
NEW WARNING! Risk Of Stroke When The Antipsychotic Risperidone (RISPERDAL) Is Prescribed For Dementia
June 2003
The manufacturer of the antipsychotic drug risperidone (RISPERDAL), announced on April 16, 2003, that an important new warning had been added to the professional product labeling, or package insert, for the drug concerning cerebrovascular adverse effects, including stroke and transient ischemic attack (temporary reduction of blood flow to the head), when the drug is used to treat elderly patients for dementia. In some of these cases the result was death.
The Calcium Channel Blocker Verapamil (COVERA HS) For High Blood Pressure - Manufacturer Halts Important Clinical Trial
June 2003
This study does provide additional support to what the National Institutes of Health and the Health Research Group have been saying for years: low-dose hydrochlorothiazide should be the first drug used in the treatment of mild to moderate high blood pressure.
Resisting Antibiotic-Resistant Bacteria
June 2003
The new FDA regulations embody the principles we wrote about 14 years ago in the first edition of Worst Pills, Best Pills on how you can avoid the unnecessary use of antibiotics:
Calcium By Any Other Name is Still Calcium
May 2003
The jackals selling unregulated dietary and herbal supplements have been hard at it bombarding the public with preposterous, unsubstantiated claims about the superiority of their particular miracle natural calcium products. Some disreputable companies have gone beyond just claiming a better calcium product and are now declaring that “coral calcium,” for example if it is from Okinawa, is the secret to good health and a long life.
Do Not Use! Natural or Desiccated Thyroid (ARMOUR THYROID) For Thyroid Hormone Replacement Therapy
May 2003
We wrote in the first edition of Worst Pills, Best Pills, published in 1988, that natural or desiccated (dried) thyroid extract products, such as ARMOUR THYROID, should not be used except by those who have successfully taken it for years to control their symptoms of low thyroid hormone production (hypothyroidism).
Do Not Use! Reports of Blood Clots With the Use of the Oral Contraceptive Drospirenone With Ethinyl Estradiol (YASMIN)
May 2003
You should not use Yasmin for the reasons we stated in the April 2002 newsletter. Some physicians may believe that Yasmin is less likely to cause blood clots than older oral contraceptives; however, there is no research to support such a belief.
The Tetracycline Antibiotic Minocycline (MINOCIN) and Benign Intracranial Hypertension
May 2003
Benign intracranial hypertension is, in fact, not benign at all. It is also known as pseudotumor cerebri and involves a persistent rise in cerebrospinal fluid pressure. This reaction is characterized by headache, nausea, vomiting and papilledema (a sign of increased pressure within the central nervous system) with partial paralysis of a nerve that controls eye movement and some facial muscles (sixth cranial nerve palsy). If you are taking minocycline or another tetracycline and develop a persistent unexplained headache, this should be reported to the prescribing physician immediately.
Stronger Warnings for the Fluoroquinolone Antibiotic Gatifloxacin (TEQUIN)
May 2003
Stronger warnings have been added to the professional product label, or “package insert,” for the fluoroquinolone antibiotic gatifloxacin (TEQUIN) about possible heart rhythm disturbances and problems with blood sugar control. This drug was approved by the Food and Drug Administration (FDA) in October 2001 and its marketing brought to nine the number of fluoroquinolone antibiotics on the market.
DO NOT USE! Teriparatide (FORTEO) — A New Drug For Osteoporosis
April 2003
Teriparatide should not be used by men. Clearly, without evidence that teriparatide reduces fracture, the possibility of osteosarcoma outweighs any theoretical benefit of the drug. Our recommendation for women is the same, but for different reasons. There is evidence of reduced fracture risk in both vertebral and non-vertebral locations; however, the absolute risk of vertebral fracture reductions is not large and many vertebral fractures are asymptomatic. Finally, alendronate appears to offer a comparable level of protection without the concerns of osteosarcoma.
DO NOT USE! Nitrofurantoin (FURADANTIN, MACRODANTIN, MACROBID) — Adverse Effects On the Lungs
April 2003
Older adults should not use nitrofurantoin long term for the treatment of urinary tract infections. If you develop the symptoms of acute lung toxicity listed above, contact your physician immediately.
Resisting Antibiotic-Resistant Bacteria
April 2003
The new FDA regulations embody the principles we wrote about 14 years ago in the first edition of Worst Pills, Best Pills on how you can avoid the unnecessary use of antibiotics:
New Warning! Heart Valve Damage With the Parkinson’s Disease Drug Pergolide (PERMAX)
April 2003
On February 24, 2003, Eli Lilly and Company of Indianapolis informed healthcare professionals that the professional product labeling, or “package insert,” for pergolide (PERMAX) was being updated to include a warning about the possibility of heart valve damage with the drug.
Selling New Drugs Using Smoke and Mirror (Images)
March 2003
You should avoid these "new" single mirror images of old drugs, not out of concern about their safety or effectiveness, but because they are the same as the old drugs. In the long run, they cause economic harm both to individuals and to the health care system because they have come on the market with extended monopoly protection. Article lists some examples.
Important Safety Alert! Antidepressant Nefazodone (SERZONE) Withdrawn From the Market In All European Countries
March 2003
Bristol-Myers Squibb of Princeton, NJ announced on January 8, 2003 that it will pull the antidepressant nefazodone (SERZONE) in all European countries where it is marketed. The drug was withdrawn from the Swedish market in early 2002 and from Denmark in December 2002 after concerns about liver toxicity. If you or a family member are currently taking nefazodone, discuss with the prescribing physician switching to one of the numerous other, safer antidepressant drugs now on the market.
Important Safety Alert! DO NOT USE — Asthma Inhaler Salmeterol (SEREVENT)
March 2003
DO NOT STOP ANY ASTHMA MEDICATION WITHOUT FIRST CONSULTING YOUR PHYSICIAN. ABRUPTLY STOPPING A MEDICATION MAY RESULT IN ACUTELY DETERIORATING ASTHMA CONTROL. An interim analysis of a company study of outcomes suggested that the drug may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths.
Overdoses and Lung Toxicity With Methotrexate When Used for Rheumatoid Arthritis and Other Diseases
March 2003
The Institute for Safe Medication Practices (ISMP), with the knowledge of the FDA, issued an alert about methotrexate overdoses that occur when the drug is incorrectly prescribed or used daily rather than weekly.
New Warning For OTC Drugs Containing the Antihistamine Diphenhydramine (BENADRYL)
February 2003
On December 5, 2002, the Food and Drug Administration (FDA) announced that a new warning statement would be required on the labels of all over-the-counter (OTC) antihistamine, anti-nausea, anti-cough and nighttime sleep-aid drug products containing diphenhydramine citrate or diphenhydramine hydrochloride. The statement advises consumers not to use oral OTC diphenhydramine products with any other product also containing diphenhydramine, including products used on the skin (topically).Article lists products.
Foggy Thinking as Inhaled Flu Vaccine Nears FDA Approval
February 2003
If you’re between 50 and 64, get vaccinated if you are in a high-risk group. In any event, get vaccinated with the old, proven inactivated flu vaccine, rather than one with so much murky science behind it as FLUMIST.
Breathing Problems In Older Adults Using Beta-Blocking Eye Drops For Glaucoma
February 2003
Beta-blockers, a family of drugs frequently prescribed for high-blood pressure, are also very useful (as eye drops) in controlling elevated pressure in the eye (glaucoma). Because beta-blocking drugs, including the topical products, affect both the heart and the lungs these drugs should not be used in patients with bronchial asthma or a history of that disease
Massive Study Confirms That Inexpensive Water Pills (DIURETICS) Should Be Used First In Treating High Blood Pressure
February 2003
The results of a very large clinical trial designed to give a definitive answer to the decades-old question of which of four commonly used families of high blood pressure medications should be prescribed first was published in the December 18, 2002 issue of the Journal of the American Medical Association. The answer is that the oldest drugs — known as the thiazide diuretics, or water pills — are superior in preventing one or more major forms of cardiovascular disease to the other families of drugs. DO NOT STOP TAKING ANY HIGH BLOOD PRESSURE MEDICATION WITHOUT FIRST CONSULTING YOUR PHYSICIAN.
Government Publishes Adult Immunization Schedule
February 2003
In this issue of the Health Letter, we reprint those graphics in their entirety, along with some rather technical footnotes that accompany the charts. You should show this information to your doctor, in case he or she hasn’t seen it.
Tamoxifen (Nolvadex) for Breast Cancer Prevention?
February 2003
In order that they suffer the least harm, women need to be fully informed about the results coming from these tamoxifen “prevention” trials. They need to realize that the current poor risk assessment tool coupled with the increase in possible serious illnesses or death is a poor foundation on which to base their hopes by taking tamoxifen for many years.
Do Not Use! The Water Pill (diuretic) Indapamide (LOZOL) for High Blood Pressure
January 2003
The August 2002 issue of the Australian Adverse Drug Reactions Bulletin reviewed reports of low blood levels of sodium (hyponatremia) induced by the water pill, or diuretic, indapamide (LOZOL). The main symptoms of hyponatremia involve the central nervous system and include lethargy, confusion, stupor, or coma. If you are taking indapamide for high blood pressure, you should ask your doctor why you have not been prescribed hydrochlorothiazide.
Valacyclovir (VALTREX), Penciclovir (DENAVIR), and Docosanol (ABREVA) – How Much is One Day Without a Cold Sore Worth?
January 2003
The editors of the highly respected Medical Letter On Drugs and Therapeutics, an independent source of drug information written for physicians and pharmacists, reviewed the use of the antiviral drug valacyclovir (VALTREX) for the treatment of cold sores (herpes labialis) in their November 11, 2002 issue. This prompted us to evaluate two other Food and Drug Administration (FDA) approved drugs, penciclovir (DENAVIR) and docosanol (ABREVA), together with valacyclovir for cold sore treatment. If you decide not to spend the money for one of these drugs every time a cold sore appears, there are things you can do to control discomfort, allowing healing and avoid complications. The cold sore should....
Do Not Use! New Safety Warning Added to the Arthritis Drug Valdecoxib (BEXTRA)
January 2003
There is an additional similarity (aside from our listing both as DO NOT USE drugs) between valdecoxib and celecoxib, both are sulfa drugs and individuals who are allergic to sulfa drugs should not use them. Although celecoxib came on the market with a warning about sulfa drug allergy, valdecoxib did not. We previously wrote “It may be a dangerous oversight on the part of the FDA not to have required the same warning for valdecoxib.” Unfortunately, because uninformed patients have been needlessly harmed, our prediction has come to pass.
Do Not Use Until October 2005 Escitalopram (LEXAPRO) – The Sixth Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressant
January 2003
Escitalopram (LEXAPRO) was approved by the Food and Drug Administration (FDA) in August 2002 and brings to six the number of selective serotonin reuptake inhibitor (SSRI) antidepressants now on the market in the U.S. The primary purpose for developing escitalopram appears to be nothing more than a strategy to protect sales as citalopram nears the end of its patent protection. In the long run, escitalopram will cause economic harm to individuals and the healthcare system.
Review of Adverse Effects and Contraindications of Various Dietary Supplements Used for Weight Loss
December 2002
Ephedra, or ma huang, the natural form of the stimulant ephedrine, the most infamous and dangerous drug found in dietary supplements sold for weight loss, is at last beginning to receive the negative notoriety it deserves. Ephedra causes heart attacks and strokes because of its ability to raise blood pressure and heart rate. Article discusses the risk of other dietary supplements.
Arthritis Drug Rofecoxib (VIOXX) Linked to Increased Risk of Coronary Heart Disease
December 2002
Investigators from Vanderbilt University in Nashville TN, in a study published in the October 5, 2002 issue of The Lancet, found that patients taking 50 milligrams per day of the arthritis and painkilling drug rofecoxib (VIOXX) for longer than five days are 70 percent more likely to develop coronary heart disease (CHD) than nonusers of the drug.
How to Report Adverse Reactions to the FDA
December 2002
Consumers can play an important public health role by reporting any adverse experiences with drugs, devices, or dietary and herbal supplements to the Food and Drug Administration (FDA). This can be done through the MedWatch program, the FDA’s medical products reporting system. Article shows how to file a report.
Drug Safety Withdrawals: Who is Responsible for Notifying Patients?
December 2002
The following editorial, by Health Letter Editor Dr. Sidney Wolfe, appeared in the December issue of Pharmacoepidemiology and Drug Safety. Ultimately, the cost for such notification should be borne by the pharmaceutical company making the dangerous drug. Pharmacists and/or physicians, if the latter have record access, should be reimbursed for doing the company’s work. In addition, the FDA should be given new legislative authority to impose mandatory drug recalls with an enforceable withdrawal schedule governing the level and rapidity of recall and patient notification.
The Corruptible Academic-Industry Partnership
December 2002
The past decade has seen a ballooning in private industry support for biomedical research. While the federal government was once the major funder of medical research, corporations are now the primary sponsors.
Drug Induced Psychiatric Symptoms (Part 2)
November 2002
This is the second of a two-part series on drug-induced psychiatric symptoms that began in last month’s Worst Pills, Best Pills News. The information is based on the July 8, 2002 issue of The Medical Letter on Drugs and Therapeutics. Article lists drugs and adverse effects.
New Safety Warnings! Dihydroergotamine (DHE 45 INJECTION, MIGRANAL NASAL SPRAY) for Migraine Headache
November 2002
On July 31, 2002, the strongest type of drug safety warning that the Food and Drug Administration (FDA) can require, a black box warning, was added to the professional product labeling, or “package insert,” for the migraine headache drug dihydroergotamine (DHE 45 INJECTION, MIGRANAL NASAL SPRAY). The new warning involved numerous drug interactions between dihydroergotamine and other drugs that can raise the blood levels of dihydroergotamine leading to a life-threatening contraction of blood vessels (vasospasm) that can block the flow of blood to the brain and other areas of the body.
FDA Caves In to Industry, Fails to Adequately Address Acetaminophen (TYLENOL) Overdoses
November 2002
Most of us remember the 1982 debacle in which Tylenol capsules laced with cyanide were held responsible for seven deaths. These tragic events led to a reimagining of tamper-resistant drug packages. This article discusses overdoses.
FDA Caves In to Industry, Fails to Adequately Address Tylenol Overdoses
November 2002
Most of us remember the 1982 debacle in which Tylenol capsules laced with cyanide were held responsible for seven deaths. These tragic events led to a reimagining of tamper-resistant drug packages. Yet a far greater Tylenol-related tragedy has been unfolding before and since 1982—preventable deaths due to overdoses from acetaminophen (the active ingredient in Tylenol and many other prescription and over-the-counter drugs) and the resultant liver damage. In fact, acetaminophen is the leading cause of toxic drug ingestions in the U.S.
GAO Report Backs Link Between Drug User Fees and Higher Rate of Drug Withdrawals
November 2002
A report from the General Accounting Office (GAO), an investigative branch of Congress, shows that since the Prescription Drug User Fee Act (PDUFA) was implemented in 1992, a higher percentage of newly approved drugs has been withdrawn than before. In the period 1993-1996, as PDUFA was being fully implemented, the drug withdrawal rate was 1.56 percent, compared to 5.34 percent in the period 1997-2000.
Drug Induced Psychiatric Symptoms
October 2002
This is the first of a two part series on drug induced psychiatric symptoms that is based on the July 8, 2002 issue of The Medical Letter on Drugs and Therapeutics. Regular readers of Worst Pills, Best Pills News will recognize The Medical Letter as a reference source written for physicians and pharmacists that we often use because of its reputation as an objective and independent source of drug information. The article lists the drugs and their psychiatric adverse effects.
Will a Vitamin a Day Keep the Doctor Away?
October 2002
A June 20, 2002 press release from the Council for Responsible Nutrition (CRN) proclaimed: “Harvard Researchers Publish JAMA [Journal of the American Medical Association] Articles Recommending Vitamin Supplements For All Adults.” The studies concerned vitamins for chronic disease prevention. However, if you are a well-nourished elderly person living at home, taking vitamin E may actually increase the number of times you must see your doctor.
FDA Issues Warning about Chinese Diet Pills Containing the Banned Diet Drug Fenfluramine (PONDIMIN)
October 2002
On August 13, 2002, the Food and Drug Administration warned the public about the Chinese weight loss products CHASU (JIANFEI) DIET CAPSULES and CHASU GEMPI because they pose a potential public health risk. The alert followed illnesses reported in several people in Japan, some of whom died, after consuming these products.
Alzheimer's Prevention Study Should Be Stopped
October 2002
On September 4, 2002, Public Citizen sent a letter to Health and Human Services (HHS) Secretary Tommy Thompson asking that an Alzheimer’s Disease (AD) prevention trial be immediately stopped and that the patients be provided with information on the risks to which they may already have been exposed.
Canada Bans the Dangerous Herbal Supplement Kava-Kava
October 2002
Canada joined the growing list of countries that have banned the herbal supplement kava-kava because of liver toxicity that in some cases has resulted in liver transplants and death (see the May 2002 issue of Worst Pills, Best Pills News). An immediate ban and a recall at all levels of the market was announced by Canadian health authorities on August 21, 2002.
Will a Vitamin a Day Keep the Doctor Away?
October 2002
Will a vitamin a day keep the doctor away? If you are malnourished or a strict vegetarian trying to prevent chronic disease due to a vitamin deficiency maybe, but there is also the possibility of harm. If you are a well-nourished elderly person living at home, taking vitamin E may actually increase the number of times you must see your doctor.
Long Term Hormone Replacement Therapy (HRT): The Demise of a Standard of Practice
September 2002
We hope that by now women have heard that one part of a large, long term, government sponsored clinical trial, the Women’s Health Initiative, evaluating hormone replacement therapy (HRT) was halted prematurely. The bottom line from this trial is that long term HRT’s risks outweigh its benefits. You should not be using hormone replacement therapy for any reason other than its very short term use to control the symptoms of menopause.
New Safety Labeling Change: Chlorpropamide (DIABINESE) for Type-2 Diabetes
September 2002
A new warning was added in May 2002 to the professional product labeling, or “package insert,” for the type-2 diabetes drug chlorpropamide (DIABINESE) concerning its use in the elderly. The new warning cites increased risks of low blood sugar (hypoglycemia), low blood sodium levels (hyponatremia), or both in patients aged 65 and over.
Update on the Illegal Promotion of Gabapentin (NEURONTIN)
September 2002
Court documents revealed that senior officials at Parke-Davis determined that it was not sufficiently profitable for Parke-Davis to obtain FDA approval for gabapentin’s alternative uses mentioned above by doing the types of studies necessary for approval. Instead, company officials developed a strategy that would allow Parke-Davis to avoid the costs of proving gabapentin’s safety and effectiveness for these other uses, while allowing the company to enter the lucrative off-label markets.
Dietary Supplement Recalled for Dangerous Amounts of Lead
September 2002
On June 28, 2002, Nature’s Way Products, Inc. of Springville, Utah, recalled four lots of its 100-count Nature’s Way brand Nettle capsules because these lots were found to contain excessive amounts of lead.
New Safety Labeling Changes for Anticoagulant Warfarin (COUMADIN)
September 2002
Several new safety labeling changes have been required by the Food and Drug Administration (FDA) for the widely used anticoagulant drug warfarin (COUMADIN). These changes to the drug’s professional product labeling, or “package insert,” were made in May 2002. The article discusses the changes.
Written Drug Information Sheets Distributed by Pharmacists Fail to Meet Minimum Quality Standards
August 2002
The Food and Drug Administration (FDA) announced on June 18, 2002, the results of a national study to determine the extent of distribution and the quality of unregulated written drug information, known as “patient information leaflets” (PILs), produced by commercial information vendors to be disseminated by pharmacists to drug consumers when prescriptions are filled. The study’s results were appalling.
Black Box Warning Added to the Cancer Drug Tamoxifen (NOLVADEX)
August 2002
The strongest cautionary language that the Food and Drug Administration (FDA) can require, a so-called “black box warning,” was added to the professional product labeling, or “package insert,” for the cancer drug tamoxifen (NOLVADEX) in June 2002. The warning concerns increased risk of sometimes fatal uterine cancers, stroke and blood clots in the lungs (pulmonary embolism) in women at high risk of breast cancer who use the drug to reduce the incidence of breast cancer and in women with a form of breast cancer called ductal carcinoma in situ (DCIS).
Comparative Gastrointestinal (GI) Toxicity of Six Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
August 2002
The British equivalent of our Food and Drug Administration (FDA), in the April 2002 issue of its newsletter Current Problems in Pharmacovigilance, published a ranking of the relative gastrointestinal (GI) toxicity of some of the widely used older nonsteroidal anti-inflammatory drugs (NSAIDs). These drugs are commonly used for acute pain and the treatment of the symptoms of osteo- and rheumatoid arthritis.
Do Not Use! Dexmethylphenidate (FOCALIN) - a Methylphenidate (RITALIN) Copy
August 2002
Dexmethylphenidate (FOCALIN), approved by the Food and Drug Administration (FDA) in November 2001 for attention-deficit/hyperactivity disorder (ADHD), joins a growing list of Do Not Use drugs, so called because they primarily result in economic harm to both individuals and the health care system. These drugs exist solely to extend a manufacturer’s brand name monopoly position in a lucrative market but offer nothing better than the drugs they replace.
Do Not Use! Germany Bans the Dietary Supplement Kava-Kava
August 2002
Germany’s Federal Institute for Drugs and Medical Devices, the counterpart of our Food and Drug Administration (FDA), announced on June 17, 2002 a ban on the sale of the herbal dietary supplement kava-kava, to take effect immediately, because of reports of liver toxicity.
Is Your Doctor Selling You to the Highest Bidder?
August 2002
In a 1995 U.S. survey, approximately 90 percent of patients thought they should be told who paid for the study, 80 percent wanted to be told if the researcher owned stock in the company, and 85 percent wanted similar disclosure if the investigator was paid for each patient enrolled. For each of these questions, doctors recommended disclosure at somewhat lower rates. Similar disparities are apparent when doctors and patients are asked about the appropriateness of accepting knickknacks, free meals and trips to exotic locations from the pharmaceutical industry. When will the doctors catch up with their patients?
It's Botox Night at Hopkins
August 2002
For the 12th consecutive year, Johns Hopkins Hospital has come in first in the U.S. News & World Report ranking of American hospitals. Ironically, one day before receiving this honor, Hopkins came within a hair’s breadth of disgracing itself by sponsoring a “Botox Night”, in which healthy people would have received on-the-spot treatments at reduced prices in a social setting.
Public Citizen Health Research Group Publishes Companion to Worst Pills, Best Pills 1999 Edition
July 2002
Since publication of the 1999 edition of our book Worst Pills, Best Pills, a large number of drugs have come on the market. Because of many requests for an update from people who have the 1999 edition, we are publishing the Companion, which must be used in conjunction with the older book because the drugs in the Companion listed as Do Not Use refer to safer alternatives that are discussed in the 1999 edition.
Drug Induced Elevation of Blood Sugar with the Antipsychotic Drugs Clozapine (CLOZARIL) and Olanzapine (ZYPREXA)
July 2002
We are becoming increasingly concerned about reports of elevated blood sugar levels (hyperglycemia) and diabetes with the newer “atypical antipsychotic” drugs clozapine (CLOZARIL) and olanzapine (ZYPREXA).
Do Not Use! The Fluoroquinolone Antibiotic Gatifloxacin (TEQUIN)
July 2002
The approval of gatifloxacin(TEQUIN) in October 2001 brought to nine the number of fluoroquinolone antibiotics on the market, and this drug joins sparfloxacin (ZAGAM) and moxifloxacin (AVELOX) as fluoroquinolones that can cause a dangerous abnormality in the heart’s electrical conduction known as QT prolongation that can lead to fatal heart rhythm disturbances such as torsade de pointes.
Health Research Group Urges Prosecution of Abbott Labs for Concealing Death Data on Diet Drug Sibutramine (MERIDIA)
July 2002
The Health Research Group wrote Department of Health and Human Services secretary Tommy Thompson on May 21, 2002, strongly urging the criminal prosecution of Abbott Laboratories for illegally withholding from the Food and Drug Administration (FDA) important information concerning eight deaths and other adverse effects related to its diet drug sibutramine (MERIDIA). Two months earlier we had petitioned to have this dangerous drug withdrawn from the market (see the May 2002 issue of Worst Pills, Best Pills News).
Nicotine Lollipops: Sweet, Addictive, and Illegal
July 2002
A letter written by Rep.Henry A.Waxman: Although I support innovative strategies for smoking cessation, there were three problems with nicotine lollipops. First, these products pose serious risks to children. Nicotine lollipops are new, so there are no studies that examine the use of these products by children.
Outrage: Department of Health and Human Services Fails to Ban Ephedra or Issue Adequate Warnings
July 2002
The   following is a statement by Health Letter Editor, Dr. Sidney Wolfe in response to this decision: Today's announcement by the Department of Health and Human Services (HHS), which not only fails to ban ephedra dietary supplements but also fails to seriously warn against the use of these products, should result in the firing of all officials in HHS and the Food and Drug Administration (FDA) who are responsible for this dangerous cowardice. The idea that more studies are needed and that the more than 100 deaths and hundreds of other cases of serious damage to users of these products, many of which are extremely well-documented and have occurred at recommended doses, is not enough for a ban is in sharp contrast to what has usually occurred with the removal of dangerous prescription drugs from the market.
New Research Results on Safety of Newly Approved Drugs Causes Health Research Group to Extend Five-Year Waiting Rule to Seven Years
June 2002
A study published in the May 1, 2002 Journal of the American Medical Association (JAMA) has resulted in a major change in the Health Research Group’s drug safety policy. The study, in association with physicians from the Harvard Medical School, examined the frequency and timing of the identification of new adverse drug reactions resulting in the addition of a black box warning in the drug’s professional product labeling or its outright removal from the market. You should wait at least seven years from the date of release to take any new drug unless it is one of those rare “therapeutic advances” that offers you a documented therapeutic advantage over older, proven drugs.
Grapefruit Juice and Drug Interactions
June 2002
Grapefruit juice can interact with a number of therapeutically important drugs that could lead to the possibility of toxicity. These drugs are listed in the article.
Health Research Group Petitions to Ban the Arthitis Drug Leflunomide (ARAVA)
June 2002
Leflunomide (ARAVA) was approved by the Food and Drug Administration (FDA) in September 1998 for the treatment of active rheumatoid arthritis in adults. On March 28, 2002, we petitioned Health and Human Services Secretary Tommy Thompson to remove leflunomide from the market immediately.
Important New Cardiovascular Safety Warning for Rofecoxib (VIOXX)
June 2002
Rofecoxib (VIOXX), the heavily promoted and overpriced nonsteroidal anti-inflammatory drug (NSAID), now carries a warning in its professional product labeling, or “package insert,” about its use by people with a history of heart disease....If you require treatment with an NSAID you should not be taking rofecoxib.
Outrage: New Study: Wait Seven Years to Use New Drugs
June 2002
A study published in the May 1, 2002 Journal of the American Medical Association (JAMA) has resulted in a major change in the Health Research Group's drug safety policy. The study, in association with physicians from the Harvard Medical School, examined the frequency and timing of the identification of new adverse drug reactions resulting in the addition of a black box warning in the drug's professional product labeling or its outright removal from the market. Three of the authors have close identification with the Health Research Group: its director, Sidney M. Wolfe, and former HRG staffers Drs. Steffi Woolhandler and David Himmelstein. The other co-authors are affiliated with the Harvard Medical School.
Public Citizen's Health Research Group's Petition to Ban Diet Drug Sibutramine (MERIDIA)
May 2002
On March 19, 2002, Public Citizen’s Health Research Group petitioned Department of Health and Human Services (DHHS) Secretary Tommy Thompson to immediately ban the dangerous diet drug sibutramine (MERIDIA). As long ago as April 1998, we listed sibutramine as a Do Not Use drug in Worst Pills, Best Pills News.
Neurontin (GABAPENTIN) - The Illegal Corporate Creation of a Blockbuster Drug
May 2002
A March 14, 2002, New York Times article revealed that the manufacturer of the seizure medication gabapentin (NEURONTIN) illegally promoted the drug to prescribing physicians for at least 11 “off-label” (unapproved) medical conditions, using their own employees, euphemistically called “medical liaisons.” Many of the bases for the safety and effectiveness of gabapentin for these 11 unapproved uses appears to have been fabrications by the corporation.
U.S. Consumers Finally Get Warned About Liver Toxicity with the Dietary Supplement Kava-Kava
May 2002
On March 25, 2002, the Food and Drug Administration (FDA) finally issued a consumer alert about the possibility of liver toxicity with the dietary supplement drug kava kava. This action came four months after German authorities issued a similar warning to their citizens.
Calcitonin (CALCIMAR, MIACALIN) for Osteoporosis - Value Uncertain After 30 Years
May 2002
Physicians and pharmacists from the Food and Drug Administration (FDA), in the March 19, 2002, issue of the medical journal The Lancet reviewed the regulatory history of calcitonin (CALCIMAR, MIACALCIN) in the treatment of postmenopausal osteoporosis. Over six years ago, in the December 1995 issue of Worst Pills, Best Pills News, we listed calcitonin nasal spray as a Do Not Use drug because there was no credible evidence that the drug reduced the risk of fractures in postmenopausal women with osteoporosis.
Outrage: Possible Corruption at the American Heart Association
May 2002
In an article in the March 23, 2002 issue of the British Medical Journal, journalist Jeanne Lenzer lays bare the evidence that the biotech firm Genentech inordinately skewed the American Heart Association's (AHA's) guidelines on the use of "clot-busters" like Genentech's tPA (also known as alteplase or Activase), the only Food and Drug Administration-approved treatment for acute stroke.
California Health Authorities Warn Consumers about Prescription Drugs in Herbal Products
April 2002
On February 7, 2002, California health authorities warned consumers to stop immediately the use of two dietary supplement drug products, PC SPES and SPES, because they contain prescription drugs not listed on their labels that could cause serious health problems. These unregulated drug supplements are produced by BotanicLab of Brea, California. TEST
Do Not Use! The New Birth Control Pill Drospirenone With Ethinyl Estradiol (YASMIN)
April 2002
The combination birth control pill of ethinyl estradiol with drospirenone (YASMIN) was approved by the Food and Drug Administration (FDA) in April 2001. Combination birth control pills contain the hormones estrogen and progestin. There is no medical reason that you should be using Yasmin rather than one of the older pills containing the progestins norgestrel, levonorgestrel or norethindrone.
FDA Strengthens Warnings for Droperidol (INAPSINE) after the Drug Was Banned in Britain
April 2002
In December 2001 the Food and Drug Administration (FDA) strengthened the warnings and precautions sections of the professional product labeling, or “package insert,” for droperidol (INAPSINE), an injectable tranquilizer frequently used as premedication for anesthesia, as treatment for nausea after anesthesia, and for sedation of agitated patients. Droperidol alters the heart’s electrical conductivity, known as QT prolongation, which has led to a type of fatal heart rhythm disturbances known as torsades de pointes.
New Safety Labeling Change: Black Box Warning about Heart Inflammation (Myocarditis) with Clozapine (CLOZARIL)
April 2002
The black box warning in the professional product labeling or “package insert” for the atypical antipsychotic drug clozapine (CLOZARIL) has been expanded to warn about an increased risk of fatal heart inflammation (myocarditis). A black box warning is the strongest type of warning that the Food and Drug Administration (FDA) can require in a drug’s labeling.
Do Not Use. Nateglinide (STARLIX) Not a Star for the Management of Type 2 Diabetes
April 2002
The Food and Drug Administration (FDA) approved nateglinide (STARLIX) in December 2000 to lower blood sugar levels in patients with type-2 diabetes, also referred to as adult onset or non-insulin-dependent diabetes mellitus. It is now the 13th drug approved for type-2 diabetes in this country and the second member of a new class of diabetes drugs known as meglitinides. The respected Medical Letter concluded that “Nateglinide is a short-acting hypoglycemic agent that is less convenient and less effective than sulfonylureas and much more expensive. Its long term safety remains to be established.”
Direct-to-Consumer Advertising - Education or Emotion Promotion
March 2002
This article by Worst Pills, Best Pills News Editor, Dr. Sidney Wolfe is reprinted from the New England Journal of Medicine 2002;346:524-526.
The Antihistamine Desloratadine (CLARINEX) - Son of Loratadine (CLARITIN)
March 2002
By the time you read this, desloratadine (CLARINEX)—the Schering-Plough Corporation’s replacement for their $3 billion a year antihistamine loratadine (CLARITIN)—will be on pharmacy shelves. An army of sales people will be bribing your doctor with expensive meals, gifts, and vacations to switch your prescription from loratadine to desloratadine. There is no medical reason for you to be switched from loratadine to desloratadine. However, if you use desloratadine in the short term before generic loratadine is available you will save money. If you use desloratadine after generic loratadine is marketed you will be ripped-off.
Ephedra Dietary Supplements Laced With Synthetic Stimulants
March 2002
Astrongly worded letter from the Health Research Group, dated January 31, 2002, admonished Department of Health and Human Services secretary Tommy Thompson that his “… Department has been grossly negligent in protecting Americans from what is clearly the most dangerous drug that masquerades as a food supplement, Ephedra. At least 10 products made by nine dietary supplement producers are now being sold on the Internet—products that illegally contain dangerous synthetic derivatives of ephedra.
Do Not Use! The Pain Drug Tramadol (ULTRAM/ULTRACET) and Serotonin Syndrome
March 2002
Australian drug regulatory authorities have received 171 reports of suspected adverse reactions with the pain drugs tramadol (ULTRAM) or tramadol in combination with acetaminophen (ULTRACET) since Ultram began being marketed in Australia in late 1998. In six of these reports, a very serious adverse reaction known as the serotonin syndrome was listed as the adverse reaction.
Do Not Use Until 2007! Cefditoren (SPECRACEF) - Old Japanese Antibiotic Debuts in U.S.
March 2002
Cefditoren (SPECTRACEF) was approved for sale by the Food and Drug Administration (FDA) in November 2001 making it the 23rd member of the cephalosporin family of antibiotics (semisynthetic relations of penicillin) and the 11th member of the sub-group known as third generation cephalosporins. The drug has been available in Japan since 1994.
The Same Old Sad Story - Inappropriate Prescribing to the Elderly
February 2002
“Inappropriate medication use is a major patient safety concern, especially for the elderly population.” This is the first sentence of a study published in the December 12, 2001 issue of the Journal of the American Medical Association. The majority of the 33 drugs in this study have been on the market for years........
Do Not Use! Life-threatening Liver Toxicity with the Antidepressant Nefazadone (SERZONE)
February 2002
The Food and Drug Administration (FDA) informed pharmaceutical giant Bristol-Myers Squibb Co. on December 10, 2001 that it must add a black box warning to the professional product label, or “package insert,” for the antidepressant nefazodone (SERZONE), informing doctors and pharmacists that life-threatening liver damage can occur with this drug.
New Adverse Drug Reaction: Elevated Blood Sugar from New Antipsychotic Drugs in Adolescents
February 2002
Medical officers from the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, along with a physician from the Duke University Medical Center, have reported a possible link between the use of the new antipsychotic drugs clozapine (CLOZARIL) and olanzapine (ZYPREXA) in adolescents and elevations in blood sugar levels (hyperglycemia) in 20 of these children. The report was published as a letter to the editor in the November 28, 2001 issue of the Journal of the American Medical Association.
Important Drug Warning! Dispensing Errors Continue With Lamotrigine (LAMICTAL)
February 2002
In the August 2000 issue of Worst Pills, Best Pills News we wrote about reports of dispensing errors involving the drugs lamotrigine (LAMICTAL) and terbinafine (LAMISIL). Lamotrigine is approved by the Food and Drug Administration (FDA) for certain types of seizure disorders and terbinafine for the treatment of toenail and fingernail fungal infections.
No Evidence to Support the Use of Progesterone in the Management of Premenstrual Syndrome (PMS)
February 2002
Researchers from the United Kingdom reported in the October 6, 2001 issue of the British Medical Journal that published medical evidence does not support the use of progesterone in the treatment of premenstrual syndrome (PMS) and that it is unlikely that progestogens are effective in this disorder.
Canadians Begin Recall of Dangerous Drug Supplement Ephedra
February 2002
On January 9, 2002, Canadian regulatory authorities announced the initiation of a voluntary recall of certain products containing the drug supplement Ephedra and one of its pure chemical constituents, ephedrine. Ephedra and ephedrine are mostly found in dietary supplements promoted for weight loss and energy enhancement.
New Study Shows Low Income Minority Seniors Restrict Use of Prescription Drugs
February 2002
Forty-three percent of those people without prescription drug coverage who are of minority ethnicity, have annual incomes of less than $10,000 and have out-of-pocket prescription drug costs of more than $100 per month reported restricting their use of prescribed medicines.
Do Not Use! The Flu Drug Zanamivir (RELENZA) Revisited
January 2002
Editor’s Note: We are reprinting our first review of zanamivir (RELENZA) that appeared in the November 1999 issue of Worst Pills, Best Pills News. Over the past two years no credible evidence has been published that would alter our view that this drug lacks meaningful therapeutic value in the treatment of influenza.
Do Not Use! Germans May Ban the Dietary Supplement Drug Kava-Kava
January 2002
According to a story from Reuters Health News on November 20, 2001, German authorities are considering a ban on the sale of products containing more than tiny amounts of the herb Kava-Kava after reports of 24 cases of liver damage linked to the “drug” in Germany. We verified this report with colleagues who provided us with additional references linking Kava-Kava to liver damage.
Do Not Use! LIPOKINETIX - A Liver Toxic Dietary Supplement Weight Loss Drug
January 2002
LIPOKINETIX is a concoction of five drugs of doubtful or no therapeutic value in reducing the morbidity and mortality associated with obesity and lack of exercise: 1) nor-ephedrine (also known as phenylpropanolamine or PPA); 2) caffeine; 3) yohimbine; 4) diiodothyronine; and 5) sodium usniate. Each of the drugs is discussed below.
Preventable Drug-Induced Injury: What is the Last Line of Defense?
December 2001
A study published in the October 3, 2001, Journal of the American Medical Association reveals the extent of inappropriate prescribing by physicians and the equally inappropriate dispensing by pharmacists of cisapride (PROPULSID), a dangerous nighttime heartburn drug that was removed from the market in March 2000 because of fatal heart rhythm disturbances (see the March 2000 issue of Worst Pills, Best Pills News). Before using a new prescription drug, ask your pharmacist for the drug’s professional product labeling or “package insert.” This is not the same as the automatically-dispensed, information-deficient sheet you usually get.
Do Not Use. Europeans Strengthen Liver Toxicity Warnings on the Arthritis Drug Leflunomide (ARAVA)
December 2001
Leflunomide (ARAVA) was approved by the Food and Drug Administration (FDA) on September 10, 1998 to reduce signs and symptoms of active rheumatoid arthritis in adults and to retard structural damage as evidenced by X-ray erosion and joint space narrowing. The drug is sold by Aventis Pharmaceuticals Inc. If you are now taking leflunomide you should discuss with your doctor the European recommendations for liver testing and strongly consider switching to a less dangerous drug.
Dangers of Pharmacy Compounding: 1000-fold Overdose of Clonidine (CATAPRES) Used in a Child for Attention Deficit/Hyperactivity Disorder (ADHD)
December 2001
Physicians at Texas Tech University’s Health Sciences Center in Lubbock reported, in the August issue of the journal Pediatrics, the case of a five-year-old boy who received a massive overdose of the high blood pressure lowering drug clonidine (CATAPRES) that was being used to treat Attention Deficit/Hyperactivity Disorder (ADHD). Thankfully, he survived.
Two New Warnings! Tuberculosis and Heart Failure with Infliximab (REMICADE)
December 2001
Two new warnings about increased risk of tuberculosis and heart failure were issued for the arthritis drug infliximab (REMICADE) on October 23, 2001. Infliximab is approved by the Food and Drug Administration (FDA) for use in combination with methotrexate (RHEUMATREX), also an arthritis drug, for treating moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to methotrexate alone.
FDA’s ‘New’ Program to Prevent Birth Defects Caused By Acne Drug Isotretinoin (ACCUTANE) Is Powerless
December 2001
The Food and Drug Administration (FDA) announced a “new” program on November 1, 2001 to prevent pregnancies and eliminate fetal exposure in women taking the acne drug isotretinoin (ACCUTANE) produced by Roche Laboratories of Nutley, New Jersey. The stated goals of the program are that: 1) no woman should begin isotretinoin treatment if she is pregnant; and 2) no pregnancies should occur while a woman is on the drug. You or your children should only use isotretinoin in the case of severe recalcitrant nodular acne after other safer acne treatments have been tried and failed.
How You Can Report Adverse Reactions to the Food and Drug Administration
December 2001
Consumers can play an important public health role by reporting to the Food and Drug Administration (FDA) any adverse experience with drugs and medical devices, including dietary and herbal supplements. This can be done through MedWatch, the FDA’s medical products reporting program. Article included an adverese reaction reporting form.
Esomeprazole (NEXIUM)—The Fifth Proton Pump Inhibitor To Suppress Stomach Acid
November 2001
The Food and Drug Administration (FDA) approved esomeprazole (NEXIUM) on February 20, 2001 as the fifth member of the “proton pump inhibitor,” or PPI, family of drugs. These drugs work by blocking the final step in the secretion of stomach acid for the treatment of various forms of ulcer and gastroesophageal reflux disease (GERD) often manifested as nighttime heartburn. If you are currently taking omeprazole and your symptoms are being adequately controlled, there is no medical reason for you to switch to esomeprazole. Keep an eye out for the release of generic omeprazole, it may save you from 40 to 60 percent at the pharmacy.
Drugs for Possible Exposure to Anthrax: What Makes Sense?
November 2001
With each new day come new reports of exposures, possible exposures and what turn out to be fake exposures to anthrax. Originally coming from Florida, reports are now emanating from other states including New York, Nevada and the District of Columbia.
Merck’s Promotion Of Its Arthritis Drug Rofecoxib (VIOXX) Crosses Legal Lines And Poses Public Danger
November 2001
The Food and Drug Administration (FDA) on September 17, 2001 made public a Warning Letter it had issued to Merck & Co. about a false and misleading promotional campaign that the pharmaceutical giant had been conducting on behalf of its blockbuster arthritis drug rofecoxib (VIOXX).The FDA said, "Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)."
Serious Vision Disorder With Topiramate (TOPAMAX)
November 2001
Health care professionals were notified on September 26, 2001 about an eye disorder in some patients taking the seizure drug topiramate (TOPAMAX). This condition is characterized by acute myopia (nearsightedness) and secondary-angle closure glaucoma.
Outrage: The Lupron Loophole--and the Doctors Who Exploited It
November 2001
Just in case the bilking of hundreds of cancer patients wasn't enough to induce doctors to prescribe Lupron, the company also offered a doctor $65,000 in an "educational grant" if he would reverse his decision to recommend only Zoladex at his HMO. And it feted doctors with junkets to expensive golf and ski resorts and by picking up cocktail party bar tabs.
Outrage: Do Not Use Ephedra
October 2001
This Is a Dangerous Substance and Should Be Taken off the Market.
Outrage: Crouching Government, Hidden Snake Oil
September 2001
Recently, outside the Public Citizen offices in Dupont Circle, a fluorescent yellow flyer appeared heralding the arrival of an "Immunity Breakthrough!! Biochoice". This "clinically proven" product was said to be "effective against viruses and bacteria" and "directed against microorganisms of human concern.
Latin America: the Answer to Drug Companies' Problems?
April 2001
Once again, U.S. researchers are proposing a study in developing countries in which poor people would receive placebos instead of proven, lifesaving therapies. And this time, the U.S. government, in the form of the Food and Drug Administration (FDA), is playing a leading role.
Food and Drug Administration (FDA) Issues Urgent Recall Of Injectable Drugs
March 2001
The Food and Drug Administration (FDA) on January 25, 2001, issued an urgent recall of 38 injectable drugs marketed by Phyne Pharmaceuticals of Scottsdale, Arizona. Another company, AMRAM Incorporated, of Rathdrum, Idaho, manufactured these products for Phyne, which was AMRAM’s sole customer.
New Safety Warning For the Alzheimer’s Disease Drug Rivastigmine (EXELON)
March 2001
In the January 2001 issue of Worst Pills, Best Pills News we recommended that the new Alzheimer’s disease drug rivastigmine (EXELON), the third such drug on the market, should not be used for at least five years. This would be April 2005.
The Italian Drug Glucosamine (XICIL) In the Treatment Of Osteoarthritis
March 2001
An excellent Belgian study appearing in the January 27, 2001 issue of the highly respected British medical journal The Lancet found that glucosamine (XICIL) was more effective than an inactive dummy pill, or placebo, in relieving the symptoms of osteoarthritis. Glucosamine may also have a positive effect in modifying the course of osteoarthritis compared to no treatment at all. But until the results of a large NIH study are finished, avoid using this supplement.
Major Breakthroughs In the Prevention and Treatment Of High Blood Pressure
March 2001
You may be able to prevent on your own or treat your high blood pressure, in consultation with your doctor, by instituting the type of dietary lifestyle changes tested in these two clinical trials.
Review of Anti-Seizure Drugs For Bipolar Disorder
March 2001
The editors of the highly respected Medical Letter on Drugs and Therapeutics, for doctors and pharmacists, reviewed evidence from controlled clinical trials of anti-seizure drugs for psychiatric disorders in the December 11, 2000 issue. Controlled clinical trials are the “gold standard” for testing the effectiveness of drugs.
COX-2 Inhibitors Vioxx and Celebrex: Keep Staying Away--It Gets Worse
March 2001
 In light of the above discussion, we continue to advise the patient-protective five-year-rule for these drugs, as we do for all other new drugs that are not breakthroughs. Do Not Use.
Irritable Bowel Syndrome (IBS) Drug Alosetron (LOTRONEX) Withdrawn From the Market
January 2001
Glaxo Wellcome, the producer of the dangerous irritable bowel syndrome (IBS) drug alosetron (LOTRONEX), announced on November 28, 2000 that, at the request of the Food and Drug Administration (FDA), the drug would be withdrawn from the market. Alosetron caused numerous cases of ischemic colitis, a decrease of blood flow to the GI tract that can lead to inflammation, bleeding, and perforation of the GI tract resulting in infection of the abdominal cavity.
Do Not Use Before April 2005 Rivastigmine (EXELON)—A Third Drug For Alzheimer’s Disease
January 2001
The Food and Drug Administration (FDA) approved a third drug, rivastigmine (EXELON), in April 2000 for the treatment of mild to moderate dementia of the Alzheimer’s type. Rivastigmine was preceded by tacrine (COGNEX) approved in September 1993 and donepezil (ARICEPT) cleared by the FDA in November 1996.
Older Adults Not Getting the Most Effective Drugs For High Blood Pressure
January 2001
“You, or at least many of your colleagues, have failed to provide optimal care to your patients with high blood pressure.” This stinging critique of physician prescribing practices starts off an editorial in the Journal of General Internal Medicine for October 2000 that commented on a Harvard Medical School study of high blood pressure in older adults that appeared in the same issue.
FDA Safety Office Recommends Warning About Liver Failure With The Cholesterol Lowering “Statin” Drugs
January 2001
The Food and Drug Administration’s (FDA) Office of Postmarketing Drug Risk Assessment (OPDRA) recommended in a memorandum dated May 1, 2000, that liver failure be included as an adverse reaction in the professional product labeling, or “package insert” for the family of cholesterol-lowering drugs known as “statins.” The statins now being marketed in the U.S. are .....

ADDITIONAL INFORMATION FROM PUBLIC CITIZEN
Alzheimer’s Drug Lecanemab (Leqembi) of Greater Concern than Little-Used Aducanumab (HRG Publication #2673)
Biogen said on Wednesday that it would give up ownership of the controversial Alzheimer’s drug aducanumab (Aduhelm) and withdraw it from the U.S. market. In 2021, Public Citizen expressed outrage about the “indefensible decision” of the Food and Drug Administration (FDA) to grant aducanumab accelerated approval, characterizing the action as “one of the most irresponsible and egregious decisions in the history of the agency.”
Testimony Before the FDA’s Pulmonary-Allergy Drugs Advisory Committee Meeting Regarding Gefapixant for the Treatment of Chronic Cough (HRG Publication #2669)
In testimony before the Food and Drug Administration’s (FDA’s) Pulmonary-Allergy Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve gefapixant for the treatment of chronic cough because the small effects of treatment with the drug do not provide substantial evidence of a clinically meaningful benefit for patients.
Testimony before the Food and Drug Administration’s Cellular, Tissue, and Gene Therapy Advisory Committee Regarding Debamestrocel (MSC-NTF, NurOwn; Brainstorm Cell Therapeutics) as a Potential Treatment for Amyotrophic Lateral Sclerosis (BLA 125782) (HRG Publication #2667)
In this testimony, Public Citizen argues against approval of debamestrocel (autologously transplanted mesenchymal stromal cells engineered to secrete increased levels of neurotrophic factors, MSC-NTF) as treatment for amyotrophic lateral sclerosis (ALS) because the biologic drug has yet to demonstrated safety and effectiveness for that indication.
Testimony before the Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee Meeting Regarding the ITCA 650 Drug-Device for Type 2 Diabetes (HRG Publication #2666)
In this oral, public testimony, Public Citizen argues against approval of the ITCA 650 drug-device combination (NDA #209053) as an adjunct treatment for glycemic control in persons with type 2 diabetes because the device has yet to demonstrate that it is reasonably safe and effective.
Press Statement: FDA Must Prioritize Removal of Oral Phenylephrine From Shelves (HRG Publication #2665)
As a follow-up on Public Citizen’s testimony urging the Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee to vote against the efficacy of oral phenylephrine for nasal congestion, we are asking the agency to prioritize prompt removal of this drug from the U.S. market.
Testimony Before the FDA’s Nonprescription Drugs Advisory Committee Regarding the Efficacy of Oral Phenylephrine as a Nasal Congestion (HRG Publication #2664)
In a PC testimony before the Food and Drug Administration’s (FDA’s) Nonprescription Drugs Advisory Committee (NDAC), Public Citizen urged the committee to vote “No” on the questions regarding whether the current evidence supports the effectiveness of orally administered oral phenylephrine for nasal congestion and whether a higher oral dosage of the drug would be safe and effective. This is because the current evidence — from updated FDA analysis of original prior studies that had used outdated technology/research design as well as evidence from three new well-designed clinical trials — clearly shows that orally administered phenylephrine is not effective at any dose that can be administered with a reasonable margin of safety.
Press Statement: FDA Approval of Lecanemab (Leqembi) for Alzheimer’s Disease Fails Patients and the Public (HRG Publication #2661)
The U.S. Food and Drug Administration (FDA) today gave full approval to the drug lecanemab (Leqembi) to treat adults with Alzheimer’s disease. In January Public Citizen urged the agency not to approve the drug, and in June Public Citizen urged the agency not to grant full approval.
Letter to the FDA opposing accelerated approval of the gene therapy SRP-9001 as a treatment for ambulatory Duchenne muscular dystrophy (DMD) (HRG Publication #2660)
In a letter to leaders at the Food and Drug Administration (FDA), Public Citizen urged that the accelerated approval application for the biologic drug SRP-9001 (a gene therapy) for Duchenne muscular dystrophy (DMD) be rejected because of concerns about effectiveness, safety and regulatory history.
Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding Lecanemab for the Treatment of Alzheimer’s Disease (HRG Publication #2659)
In testimony before the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve the supplemental biologics license application for lecanemab for the treatment of Alzheimer’s disease, because the evidence for the drug’s benefits does not outweigh its significant risks.
Testimony before the FDA’s Gastrointestinal Drugs Advisory Committee regarding the possible accelerated approval of obeticholic acid (NDA# 212833) to treat nonalcoholic steatohepatitis with fibrosis (HRG Publication #2658)
In testimony before the Food and Drug Administration’s (FDA’s) Gastrointestinal Drugs Advisory Committee, Public Citizen urged the committee to reject accelerated approval for obeticholic acid (a synthetic bile acid) as a treatment for fatty liver disease because of inadequate efficacy on two surrogate endpoints and because of many safety concerns that included drug induced liver disease.
Testimony before the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Regarding SRP-9001 (delandistrogene moxeparvovec) for the Treatment of Duchenne Muscular Dystrophy (HRG Publication #2657)
In testimony before the Food and Drug Administration’s (FDA’s) Cellular, Tissue and Gene Therapies Advisory Committee, Public Citizen urged the committee to reject accelerated approval for SRP-9001 (a gene therapy) for Duchenne muscular dystrophy because the sponsor-presented data did not support the drug’s effectiveness and because of concerning regulatory history for related drugs.
Letter to the FDA Opposing Approval of Brexpiprazole for the Treatment of Agitation Associated with Alzheimer’s Dementia (HRG Publication #2656)
In a letter to the Food and Drug Administration (FDA), Public Citizen urged FDA to reject brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia because the drug’s small benefits do not outweigh its significant risks and because no population for which the benefits would outweigh the risks was identified.
Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe of Ineffective to Include Hydroxyprogesterone Caproate for Prevention of Preterm Birth (HRG Publication #2655)
Public Citizen petitioned the Food and Drug Administration (FDA) to promptly initiate the regulatory process to amend the list of drug products that were withdrawn or removed from the market for reasons of safety or effectiveness and that therefore may not be compounded to include hydroxyprogesterone caproate injection for prevention of preterm birth.
Testimony Before the FDA’s Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee Regarding Brexpiprazole (HRG Publication #2654)
In testimony before the Food and Drug Administration’s (FDA’s) Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve brexpiprazole for the treatment of agitation in patients with Alzheimer’s disease because the drug’s small benefits do not outweigh its significant risks.
Ineffective Medication for Prevention of Preterm Birth Should Have Been Withdrawn Years Ago (HRG Publication #2652)
Makena (hydroxyprogesterone caproate) should have been removed from the market soon after the results of the postmarket PROLONG trial demonstrating that the drug provided no clinical benefits were released in early 2019.
Letter to the FDA Urging Postponement of the Approval Decision Regarding Lecanemab for Treatment of Alzheimer’s Disease (HRG Publication #2650)
In a letter to the Food and Drug Administration (FDA), Public Citizen urged the FDA to postpone the approval decision regarding lecanemab for treatment of Alzheimer’s disease until the agency convenes an advisory committee to consider the new drug application for the drug.
Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding Omecamtiv Mecarbil For the Treatment of Heart Failure (HRG Publication #2648)
In testimony before the Food and Drug Administration’s (FDA’s) Cardiovascular and Renal Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve omecamtiv mecarbil to reduce the risk of cardiovascular death and heart failure events in adults with symptomatic chronic heart failure with reduced ejection fraction because the drug’s minimal benefits do not outweigh its significant risks.
Follow-up Comments to the FDA Regarding CDER’s Proposal to Withdraw Approval of Makena (Hydroxyprogesterone Caproate) (HRG Publication #2645)
In follow-up comments to the Food and Drug Administration regarding the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena (hydroxyprogesterone caproate) for prevention of preterm labor, Public Citizen urged the agency to take prompt regulatory action as soon as the approval of Makena is withdrawn to prevent the predictable pharmacy compounding of hydroxyprogesterone caproate for prevention of preterm birth.
Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding Daprodustat for the Treatment of Anemia Due to Chronic Kidney Disease (HRG Publication #2643)
In testimony before the Food and Drug Administration’s (FDA’s) Cardiovascular and Renal Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve daprodustat for treatment of anemia due to chronic kidney disease in adult patients not on dialysis or on dialysis because the drug offers no unique benefits compared to earlier FDA-approved erythropoiesis-stimulating agents but does have greater risks of serious adverse events.
Press Statement: FDA Commissioner, Chief Scientist Must Move Swiftly to Remove Medication for Prevention of Preterm Birth from Market (HRG Publication #2641)
Public Citizen applauds the near-unanimous recommendation of the FDA’s Obstetrics, Reproductive, and Urologic Drugs Advisory Committee to remove Makena from the market. This science-based recommendation was the only logical outcome.
Testimony Before the FDA’s Hearing on CDER’s Proposal to Withdraw Approval of Makena (Hydroxyprogesterone Caproate) (HRG Publication #2640)
In testimony before the Food and Drug Administration’s (FDA’s) hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena (hydroxyprogesterone caproate), Public Citizen argued that the agency must remove Makena from the market because it is not effective for preventing preterm birth or related fetal and neonatal health problems and death.
Letter to the FDA Opposing Approval of the Drug AMX0035 for Treatment of Amyotrophic Lateral Sclerosis (HRG Publication #2639)
In a letter to the Food and Drug Administration regarding whether the combination drug AMX0035 (sodium phenylbutyrate and taurursodiol) should be approved for treating amyotrophic lateral sclerosis, Public Citizen argued against approval because the data from a clinical trial of the drug failed to provide substantial evidence of effectiveness.
Invited Commentary Published in JAMA Internal Medicine: Curbing the Financial Incentives That Contribute to the High Prices of Prescription Drugs in the US (HRG Publication #2638)
In an invited commentary published in JAMA Internal Medicine, Public Citizen’s Dr. Sidney Wolfe explains why Congress needs to enact further legislation to curb the perverse systemic financial incentives that contribute to the high prices of prescription drugs in the U.S.
Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding the Drug AMX0035 for Treatment of Amyotrophic Lateral Sclerosis (HRG Publication #2637)
In testimony before the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, which was convened to reconsider whether the combination drug AMX0035 (sodium phenylbutyrate and taurursodiol) should be approved for treating amyotrophic lateral sclerosis, Public Citizen argued against approval because additional analyses of data from a clinical trial of the drug again failed to provide substantial evidence of effectiveness.
Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee Regarding Pimavanserin for the Treatment of Hallucinations and Delusions in Alzheimer’s Disease Psychosis (HRG Publication #2636)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve pimavanserin for the treatment of hallucinations and delusions in Alzheimer’s disease psychosis because clinical trials of the drug failed to demonstrate that it is effective.
Testimony Before the FDA’s Pharmacy Compounding Advisory Committee Regarding Adding Lorcaserin Hydrochloride to the List of Drug Products Withdrawn or Removed from the Market (HRG Publication #2635)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Pharmacy Compounding Advisory Committee, Public Citizen urged that all drug products containing lorcaserin hydrochloride be added to the list of drugs that have been withdrawn or removed from the market because they were deemed unsafe or not effective and that therefore may not be compounded under the exemptions provided by Section 503A(a) or Section 503B(a) of the Food, Drug, and Cosmetic Act.
Press Statement: CMS Resists Big Pharma Pressure Campaign, Makes the Right Call in Restricting Medicare Coverage for the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2626)
Public Citizen applauds CMS for standing its ground in the face of intense pressure orchestrated by Big Pharma and industry-funded ‘patient’ advocacy groups. The final decision restricts Medicare coverage for aducanumab to beneficiaries with Alzheimer’s disease who enroll in randomized, controlled clinical trials of the drug.
Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding the Drug AMX0035 for Treatment of Amyotrophic Lateral Sclerosis (HRG Publication #2625)
In testimony before the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen argued against approval of the combination drug AMX0035 (sodium phenylbutyrate and taurursodiol) for treating amyotrophic lateral sclerosis because clinical trial data failed to provide substantial evidence of effectiveness.
Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding Intravenous Tramadol (HRG Publication #2619)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen urged the committees to recommend that the FDA not approve an intravenous form of tramadol, a widely used but inadequately regulated opioid, for treatment of acute pain in a medically supervised health care setting.
Comments Submitted to CMS Regarding the Proposed National Coverage Determination for Aducanumab for Treatment of Alzheimer’s Disease (HRG Publication #2618)
Public Citizen strongly supports the Centers for Medicare and Medicaid Services’ (CMS’) proposed national coverage determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N), under which the Medicare program would cover the drug aducanumab only for beneficiaries who enroll in CMS-approved randomized, controlled clinical trials meeting certain criteria or in trials supported by the National Institutes of Health.
Petition to the DEA and FDA to Classify the Drug Gabapentin as a Schedule V Controlled Substance (HRG Publication #2617)
Public Citizen petitioned the Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) to add the prescription drugs gabapentin and gabapentin enacarbil to schedule V under the Controlled Substances Act to more tightly monitor and regulate use of these drugs because they are increasingly being misused, abused, and diverted, leading to dependence and overdose deaths.
Press Statement: CMS Follows the Science, Makes the Right Call in Proposing Medicare Coverage for the Alzheimer’s Disease Drug Aducanumab Only for Beneficiaries Who Enroll in a Randomized Clinical Trial (HRG Publication #2614)
Public Citizen applauds CMS for proposing to limit Medicare coverage for aducanumab to beneficiaries with Alzheimer’s disease who enroll in a randomized, controlled clinical trial of the drug.
Testimony Before the FDA’s Antimicrobial Drugs Advisory Committee Regarding the Request for Emergency Use Authorization of Molnupiravir for Treatment of COVID-19 (HRG Publication #2610)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Antimicrobial Drugs Advisory Committee, Public Citizen argued that based on the available clinical and preclinical data for molnupiravir, there is significant uncertainty regarding whether the known and potential benefits of molnupiravir for treating COVID-19 at the proposed dosage outweigh the known and potential risks of the drug.
Letter to the FDA Urging That the Composition of the Advisory Committee for the Upcoming Hearing on the Proposal to Withdraw Approval of Hydroxyprogesterone (Makena) Be Fairly Balanced (HRG Publication #2605)
Public Citizen urged the Food and Drug Administration (FDA) to make sure that the advisory committee for a planned agency hearing that will consider the agency’s proposal to withdraw the drug hydroxyprogesterone (Makena), which is approved to reduce the risk of preterm birth, from the market is fairly balanced to ensure the integrity of the hearing process and public trust in the committee’s advice and recommendations.
Comments Submitted to the CMS Regarding the National Coverage Determination Analysis for Aducanumab Treatment of Alzheimer’s Disease (HRG Publication #2598)
Public Citizen urged the Centers for Medicare and Medicaid Services (CMS) to issue a national coverage determination that excludes aducanumab from coverage under the Medicare program because there is a lack of scientific evidence that aducanumab provides any meaningful clinical benefit in terms of cognitive function outcomes in Alzheimer’s disease patients and the drug thus is not reasonable and necessary for treatment of such patients.
Press Statement: Inspector General’s Decision To Investigate FDA’s Inappropriately Close Collaboration With Biogen on the Alzheimer’s Disease Drug Aducanumab Is Long Overdue (HRG Publication #2597)
Public Citizen welcomes the Office of Inspector General’s (OIG’s) announcement today that it finally will launch a review the FDA’s implementation of the accelerated approval pathway for aducanumab and other drugs. Such an independent review is long overdue. We are particularly pleased that the OIG’s evaluation will include an examination of the interactions between the FDA and outside parties during the review and approval process of these drugs.
Comments Prepared for the CMS Listening Session Regarding the National Coverage Determination Analysis for Aducanumab for Treatment of Alzheimer’s Disease (HRG Publication #2596)
In comments prepared for the Centers for Medicare and Medicaid Services (CMS) listening session regarding the National Coverage Determination analysis for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, Public Citizen urged CMS to issue a National Coverage Determination that excludes aducanumab from coverage under the Medicare program because there is a lack of scientific evidence that aducanumab provides any meaningful clinical benefit in terms of cognitive function outcomes in Alzheimer’s disease patients and the drug thus is not reasonable and necessary for treatment of such patients.
Comments Submitted to the FDA Regarding the NDA for Roxadustat for Treating Anemia Due to Chronic Kidney Disease (HRG Publication #2595)
Public Citizen urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for roxadustat for treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis because the drug offers no unique benefits compared to earlier FDA-approved erythropoiesis-stimulating agents but does have greater risks of serious adverse events, including thromboembolic events.
Follow-up Letter to the HHS OIG Calling for Probe of Acting FDA Commissioner Woodcock’s Role in FDA’s Inappropriately Close Collaboration With Biogen (HRG Publication #2594)
Following Acting Food and Drug Administration (FDA) Commissioner Janet Woodcock’s July 9 belated request to the Department of Health and Human Services (HHS) Office of Inspector General to investigate the “interactions between Biogen and the FDA during the process leading to the decision to approve” aducanumab for treatment of Alzheimer’s disease, Public Citizen urged the OIG to examine Dr. Woodcock’s role in the unprecedented, inappropriately close collaboration between the FDA and Biogen before and after the submission of the company’s marketing application for the drug.
Press Statement: Woodcock’s Role in Aducanumab’s Approval Must Be Investigated As Part of IG Probe (HRG Publication #2593)
Public Citizen welcomes Food and Drug Administration (FDA) Commissioner Janet Woodcock’s belated request for an independent Inspector General (IG) investigation of her agency’s inappropriately close collaboration with Biogen regarding the Alzheimer’s disease drug aducanumab , as we had urged her to do nearly six months ago. Such an investigation must be broad and determine when Dr. Woodcock first became aware of this collaboration and whether she ever specifically endorsed or facilitated it in any way.
Follow-up Letter to the HHS Secretary Calling for the Resignations of Acting FDA Commissioner, Other Top Officials Responsible for Indefensible Approval of the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2591)
Following the stunning new disclosures in a detailed exposé published by STAT about how Biogen used a Food and Drug Administration (FDA) back channel to win approval for aducanumab for treatment of Alzheimer’s disease, Public Citizen again called on Department of Health and Human Services (HHS) Secretary Xavier Becerra to immediately request the resignations or seek the removal of the three officials most responsible for the indefensible decision to approve the drug, including Acting Commissioner Janet Woodcock. It is also imperative that the Secretary urge the HHS Office of Inspector General to immediately initiate a thorough investigation of the unprecedented and inappropriately close collaboration between the FDA and Biogen in the analysis of data from the key clinical trials of aducanumab, including the circumstances detailed in the STAT article.
Follow-up Letter to the HHS Office of Inspector General Requesting an Investigation of the FDA’s Unprecedented and Inappropriately Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2592)
Following the stunning new disclosures in a detailed exposé published by STAT about how Biogen used a Food and Drug Administration (FDA) back channel to win approval for aducanumab for treatment of Alzheimer’s disease, Public Citizen again called on Department of Health and Human Services (HHS) Office of Inspector General to immediately launch a formal investigation to scrutinize the unprecedented and inappropriately close collaboration between the FDA and Biogen before and after the submission of the company’s biologics license application for the new biologic drug aducanumab for treatment of Alzheimer’s disease.
Letter to the HHS Secretary Calling for the Resignations of Acting FDA Commissioner, Other Top Officials Responsible for Indefensible Approval of the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2590)
Public Citizen called on Secretary of Health and Human Services Xavier Becerra to request the resignations or seek the removal of the three officials most responsible for the agency’s indefensible decision to approve aducanumab for treatment of Alzheimer’s disease despite the lack of evidence that the drug provides any meaningful clinical benefit plus the fact that the drug has a well-documented risk of potentially serious brain injury: Acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, and CDER’s Office of Neuroscience Director Billy Dunn.
Press Statement: FDA’s Decision to Approve Aducanumab for Alzheimer’s Disease Shows Reckless Disregard for Science, Severely Damages Agency’s Credibility (HRG Publication #2583)
The Food and Drug Administration (FDA’s) decision to approve aducanumab for treatment of Alzheimer’s disease shows a stunning disregard for science and eviscerates the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
Comments Submitted to the FDA Regarding the Biologics License Application for Teplizumab for Delaying of Type 1 Diabetes Mellitus in At-Risk Individuals (HRG Publication #2582)
Public Citizen urged the Food and Drug Administration (FDA) not to approve the biologics license application for teplizumab for the proposed indication for the delay of clinical type 1 diabetes mellitus in at-risk individuals because of the lack of substantial evidence of efficacy, concerns about safety, and a lack of biocomparability between the product studied in clinical trials and the one that is intended for commercial use.
Letter to the FDA Urging the Agency Not to Approve the Biologics License Application for Donislecel for the Treatment of “Brittle” Type 1 Diabetes (HRG Publication #2579)
Public Citizen urged the Food and Drug Administration (FDA) to not approve the biologics license application for donislecel (purified allogeneic deceased donor pancreas derived Islets of Langerhans) for the treatment of “brittle” type 1 diabetes because there is not adequate evidence showing that this product has a favorable benefit-risk profile and there are serious concerns regarding the quality controls for ensuring the potency and purity of each specific lot of donislecel.
Letter to the FDA Urging the Agency to Promptly Convene an Outside Expert Advisory Panel To Revisit the Decision to Approve Remdesivir for Treatment of COVID-19 (HRG Publication #2578)
Public Citizen called on the Food and Drug Administration (FDA) to promptly convene an external expert advisory panel to evaluate whether the approval of the antiviral COVID-19 treatment remdesivir should be rescinded. The FDA approved the drug despite being aware of evidence from a major clinical trial that raised substantial doubts about whether the drug provides clinically meaningful benefit and without convening a public advisory committee meeting, as the agency routinely does prior to approving such new drugs.
Letter to the Secretary of Health and Human Services Requesting an Investigation of the FDA’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2575)
Public Citizen called on Secretary of Health and Human Services Xavier Becerra to ask his department’s Office of Inspector General to immediately investigate the unprecedented and inappropriate close collaboration between the Food and Drug Administration (FDA) and Biogen regarding the company’s application for approval of the Alzheimer’s disease drug aducanumab. The economic costs of the aducanumab to the Medicare program would be extraordinary and only justifiable for a drug that has definitive evidence of significant, clinically meaningful benefit.
Letter to the Secretary of Health and Human Services Requesting an Investigation of the FDA’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2575)
Public Citizen called on Secretary of Health and Human Services Xavier Becerra to ask his department’s Office of Inspector General to immediately investigate the unprecedented and inappropriate close collaboration between the Food and Drug Administration (FDA) and Biogen regarding the company’s application for approval of the Alzheimer’s disease drug aducanumab. The economic costs of the aducanumab to the Medicare program would be extraordinary and only justifiable for a drug that has definitive evidence of significant, clinically meaningful benefit.
Testimony before the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Tanezumab for Treatment of Osteoarthritis (HRG Publication #2573)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve tanezumab for treatment of osteoarthritis because the drug fails to provide clinically meaningful benefit compared with either placebo or oral non-steroidal anti-inflammatory drugs, but does dramatically increase the rates of rapidly progressive osteoarthritis and of total joint replacements in a dose- and duration-dependent manner.
Press Statement: FDA Must Reject Tanezumab as a Treatment for Osteoarthritis Due to Unacceptable Dangers, Little to No Benefit (HRG Publication #2572)
The Food and Drug Administration (FDA’s) pending decision regarding tanezumab for treatment of osteoarthritis should not even be a close call. A drug like tanezumab that accelerates the joint destruction of the underlying osteoarthritis disease it is intended to treat but lacks any evidence of clinically meaningful benefit in comparison to use of a placebo or oral anti-inflammatory drugs obviously should never be approved by the FDA.
Comments for the FDA’s March 24-25, 2021 Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Biologics License Application for the Osteoarthritis Drug Tanezumab (HRG Publication #2570)
Public Citizen urges the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to recommend that the Food and Drug Administration (FDA) not approve the biologics license application for tanezumab because the totality of the evidence from three published pivotal phase 3 randomized clinical trials demonstrates that the drug fails to provide clinically meaningful benefit but does dramatically increase the rates of rapidly progressive osteoarthritis and other types of serious joint damage and of total joint replacements in a dose- and duration-dependent manner. As a result, the serious risks of the drug far outweigh its benefits.
Letter to the Editor of JAMA Neurology Regarding Lack of Clarity Regarding the Disclosure of Financial Conflicts of Interest (HRG Publication #2568)
In a letter to the editor of JAMA Neurology, Public Citizen expressed concern about the apparent lack of clarity regarding the financial conflicts of interest disclosed by one of the authors of the Viewpoint article titled “Possible Consequences of the Approval of a Disease-Modifying Therapy for Alzheimer Disease,” that was published in the February 2021 issue of JAMA Neurology. The article discussed the investigational drug aducanumab for treatment of Alzheimer’s disease.
Press Statement: FDA Must Demand a New Clinical Trial of Experimental Alzheimer’s Disease Treatment Following Inappropriate Collaboration (HRG Publication #2567)
The FDA must reject the current application for aducanumab and demand that Biogen and Eisai conduct another large, placebo-controlled clinical trial before giving further consideration to approving aducanumab to treat Alzheimer’s disease. Additional flawed statistical analyses of data from the previously conducted trials of the drug will not be sufficient to establish that the drug is effective.
Press Statement: FDA Must Demand a New Clinical Trial of Experimental Alzheimer’s Disease Treatment Following Inappropriate Collaboration (HRG Publication #2567)
The FDA must reject the current application for aducanumab and demand that Biogen and Eisai conduct another large, placebo-controlled clinical trial before giving further consideration to approving aducanumab to treat Alzheimer’s disease. Additional flawed statistical analyses of data from the previously conducted trials of the drug will not be sufficient to establish that the drug is effective.
Follow-up Letter to the FDA’s Acting Commissioner Regarding the Agency’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2566)
Public Citizen urged the FDA’s new Acting Commissioner to endorse our call for the Department of Health and Human Services’ Office of Inspector General to investigate the unprecedented and inappropriate close collaboration between the FDA and Biogen before and after the submission of the company’s biologics license application (BLA) for the new drug aducanumab for treatment of Alzheimer’s disease.
Letter to Senior FDA and NIH officials Urging Changes to the Fact Sheets for Recipients of the Recently Authorized COVID-19 Vaccines (HRG Publication #2564)
Public Citizen strongly urged senior Food and Drug Administration (FDA) and National Institutes of Health (NIH) officials to promptly update the Pfizer-BioNTech and Moderna-NIH COVID-19 vaccine fact sheets for vaccine recipients and caregivers to include statements advising vaccine recipients to continue to follow the proven public health measures of mask wearing and social distancing.
Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the EUA of the Moderna-NIH COVID-19 Vaccine (HRG Publication #2563)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee, Public Citizen agreed with the need for an Emergency Use Authorization (EUA) for the Moderna-NIH COVID-19 vaccine, but argued that the fact sheet for recipients of the vaccine should advise recipients to continue following public health guidelines for wearing masks and other personal protective equipment and for social distancing to prevent transmission of the coronavirus.
Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the EUA of the Pfizer-BioNTech COVID-19 Vaccine (HRG Publication #2562)
In testimony before a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, Public Citizen agreed with the need for an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, but argued that for ethical reasons, subjects in the placebo group for the pivotal clinical trial should be offered the opportunity to be unblinded, receive the Pfizer vaccine, and continue to be followed in the trial for long-term safety and efficacy assessments.
Letter to the HHS Office of Inspector General Requesting an Investigation of the FDA’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2560)
Public Citizen called on the Department of Health and Human Services’ (HHS’) Office of Inspector General to immediately launch a formal investigation into the unprecedented and inappropriate close collaboration between the Food and Drug Administration (FDA) and Biogen before and after the submission of the company’s biologics license application (BLA) for the new drug aducanumab for treatment of Alzheimer’s disease.
Letter to the FDA’s Regarding the Agency’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2561)
Public Citizen urged the Food and Drug Administration (FDA) to endorse our call for the Department of Health and Human Services’ Office of Inspector General to investigate the unprecedented and inappropriate close collaboration between the FDA and Biogen before and after the submission of the company’s biologics license application (BLA) for the new drug aducanumab for treatment of Alzheimer’s disease.
Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding Aducanumab for Treatment of Alzheimer’s Disease (HRG Publication #2556)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve aducanumab for treatment of Alzheimer’s disease because there is not substantial evidence of effectiveness.
Press Statement: FDA Approval of Aducanumab to Treat Alzheimer’s Disease Would Be a Reckless Disregard for Science, Damage Agency’s Credibility (HRG Publication #2555)
The overall tenor of the Food and Drug Administration’s (FDA’s) briefing document for the Peripheral and Central Nervous System Drugs Advisory Committee meeting regarding aducanumab reveals that the agency is actively working hand-in-hand with Biogen, the maker of the drug, to rush to market an unproven biologic drug to treat Alzheimer’s disease that could bankrupt our health care system.
Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding a Hydrocodone-Acetaminophen-Promethazine Combination Product (HRG Publication #2554)
Public Citizen urged the FDA’s Drug Safety and Risk Management Advisory Committee Anesthetic and Analgesic Drug Products Advisory Committee to recommend the FDA not approve a hydrocodone-acetaminophen-promethazine combination product for the short-term management of acute post-operative pain severe enough to require an opioid analgesic and the prevention of opioid-induced nausea and vomiting in patients who are at risk for or have a history of nausea and vomiting because an unfavorable risk-benefit profile.
Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Combination Drug Olanzapine/Samidorphan Intended to Treat Schizophrenia and Bipolar Disorder (HRG Publication #2548)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen argued against approval of the combination drug olanzapine/samidorphan, which is intended to treat schizophrenia and bipolar disorder, because the samidorphan component is only marginally effective in decreasing the weight gain seen with olanzapine, fails to improve many other indicators of metabolic health, and
Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding an Oral Amphetamine Product Intended to be Abuse-Deterrent (HRG Publication #2547)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen argued against approval of AR19, an oral amphetamine product that is intended to be abuse-deterrent, because studies show that the drug is not expected to reduce abuse by injection or intranasal routes.
Comments on the FDA’s Proposal to Exclude 19 Bulk Drug Substances From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities (HRG Publication #2545)
Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to exclude 19 bulk drug substances from the list of bulk drug substances for which there is a clinical need under Section 503B of the Federal Food, Drug, and Cosmetic Act for pharmacy compounding by outsourcing facilities.
Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding Reformulated Oxycontin (HRG Publication #2543)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen emphasized that there is a serious question as to whether introducing abuse deterrent opioids such as reformulated Oxycontin (oxycodone) may have worsened overall public health.
Press Release: NIH Agrees With Public Citizen, Will Conduct Preclinical Trials of the Potential COVID-19 Treatment GS-441524 (HRG Publication #2539)
The National Institutes of Health (NIH) will expeditiously conduct preclinical studies of GS-441524 as a treatment for COVID-19 and will make the results readily available to the scientific community, as requested in a letter sent to the agency by Public Citizen.
Letter to the Secretary of Health and Human Services and Senior FDA and NIH Officials Opposing Emergency Use Authorization for Any COVID-19 Vaccine (HRG Publication #2536)
Public Citizen strongly urged the Department of Health and Human Services and the Food and Drug Administration (FDA) to promptly end the current dangerous consideration being given to issuing Emergency Use Authorizations (EUAs) for COVID-19 vaccines.
Letter to Gilead and Senior Federal Health Officials Calling for Immediate Study of the Antiviral Drug GS-441524 as a Potential Treatment for COVID-19 (HRG Publication #2535)
The letter asks Gilead and the federal agencies either to work collaboratively to promptly pursue the development of GS-441524 as a treatment for COVID-19 or to publicly explain and provide evidence as to why doing so is not scientifically or medically feasible.
Petition to the FDA to Require a Black-Box Warning for Commonly Used Type 2 Diabetes Drugs Known as SGLT2 Inhibitors (HRG Publication #2529)
Public Citizen petitioned the Food and Drug Administration (FDA) to add a black-box warning to the product labeling for the commonly used Type 2 diabetes drugs known as SGLT2 inhibitors, as they can lead to potentially fatal diabetic ketoacidosis in Type 1 diabetes patients for whom the drugs are not approved.
Supplement to the Petition to the DEA and FDA to Reschedule the Opioid Tramadol From Schedule IV to Schedule II (HRG Publication #2525)
Public Citizen submitted a supplement to its November 2019 petition to the DEA and FDA to reschedule the opioid tramadol from the weakly controlled schedule IV under the Controlled Substances Act to the more tightly controlled schedule II because it is overprescribed, often misused, highly addictive and potentially deadly. The supplement adds new data from a careful study of the FDA’s Adverse Event Reporting System which revealed that tramadol use correlates with severe adverse events, including death.
Letter to Gilead Sciences Regarding the Emergency Use Authorization Granted by the FDA for Remdesivir (HRG Publication #2522)
Public Citizen urged Gilead Sciences to immediately either (a) release the data regarding the safety and efficacy of remdesivir on which the Food and Drug Administration (FDA) relied in granting the company’s Emergency Use Authorization request for emergency use of remdesivir for treatment of hospitalized COVID-19 patients, or (b) inform the FDA that the company consents to the FDA’s release of such information in response to a Freedom of Information Act request submitted by Public Citizen.
Press Statement: FDA Refuses to Ban Heart-Toxic Dietary Supplements Containing Cesium, Endangering Patients and Ignoring Agency’s Own Expert Assessment (HRG Publication #2505)
By denying our request to remove dietary supplements containing cesium chloride (or any other cesium salt) from the market, the Food and Drug Administration (FDA) has ignored its obligation to protect public health. It also has allowed consumers to continue to be exposed to life-threatening dietary supplements that have been promoted without basis to vulnerable cancer patients.
Letter to the FDA Urging the Agency Not to Approve the New Drug Application for a Tramadol-Celecoxib Fixed-Dose Combination Product for Management of Acute Pain (HRG Publication #2504)
We strongly urged the FDA not to approve the new drug application submitted by Esteve Pharmaceuticals for a tramadol-celecoxib fixed-dose combination product for management of acute pain in adults because evidence from recent studies strongly counters the false assumption that tramadol, which was placed in schedule IV under the Controlled Substances Act in 2014, is safer; less likely to cause misuse, dependence, and addiction; and has a better safety profile than schedule II and schedule III opioids.
Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Opioid Oxycodegol (HRG Publication #2503)
In testimony before a joint meeting of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committees to recommend that the FDA not approve the new opioid oxycodegol, which is closely related to oxycodone, for treatment of chronic low back pain because the medication is not effective for treating this condition but has oral abuse potential comparable to currently approved oxycodone products.
Comments on the FDA’s Proposal to Amend the List of Bulk Drug Substances That Can be Used to Compound Drug Products Under Section 503A of the FDCA (HRG Publication #2501)
Regarding the Food and Drug Administration’s (FDA’s) proposal to add five bulk drug substances to the list of bulk drug substances that can be used to compound drug products under section 503A of the Food, Drug, and Cosmetic Act (FDCA), Public Citizen supports adding three of the bulk drug substances and opposes adding two. Public Citizen also strongly supports the FDA’s proposal to exclude 26 bulk drug substances from the list because of concerns regarding the substances’ safety or effectiveness.
Letter to the FDA Calling for Investigation Into an Apparent Illegal Clinical Trial That Tested Unapproved Naltrexone Implants in Prison Inmates (HRG Publication #2499)
Public Citizen and 31 doctors, bioethicists, prisoner advocates, and academics called on the FDA to immediately investigate BioCorRx, Inc. & the Louisiana Department of Public Safety and Corrections’ testing of an unapproved sustained-release naltrexone implant on prison inmates to determine its effectiveness in managing addiction disorders. Although the FDA has approved naltrexone in oral tablet & injectable forms to treat alcohol & opioid dependence, it has never approved any surgically implanted form.
Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Using Empagliflozin to Treat Patients with Type 1 Diabetes (HRG Publication #2498)
In testimony before the Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee, Public Citizen urged the FDA to reject Boehringer Ingelheim’s supplemental new drug application for empagliflozin for treatment of type 1 diabetes because the drug offers minimal benefits that do not outweigh the significantly increased risk of life-threatening diabetic ketoacidosis.
Petition to the DEA and FDA to Reschedule the Opioid Tramadol From Schedule IV to Schedule II (HRG Publication #2497)
Public Citizen petitioned the Drug Enforcement Administration and Food and Drug Administration (FDA) to reschedule the opioid tramadol from the weakly controlled schedule IV under the Controlled Substances Act to the more tightly controlled schedule II because it is overprescribed, often misused, highly addictive and potentially deadly.
Comments on the FDA’s Proposal to Exclude Nine Drugs From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities (HRG Publication #2496)
We strongly support the FDA’s proposal to exclude nine bulk drug substances from the list of bulk drug substances for which there is a clinical need for pharmacy compounding by outsourcing facilities. Each of the nominated bulk drug substances is a component of one or more FDA-approved drug products, and the nominators have failed to demonstrate that there is a clinical need for outsourcing facilities to compound drug products using the nominated bulk drug substances.
Petition to the FDA to Ban the Drug Hydroxyprogesterone Caproate (Makena), Approved for Prevention of Preterm Birth (HRG Publication #2493)
Public Citizen petitioned the FDA to immediately withdraw approval of the widely prescribed drug hydroxyprogesterone caproate (Makena) and to place this drug on the list of drug products that may not be used in pharmacy compounding. These actions were requested because the results of a recently completed post-market clinical trial showed that it is not effective for preventing preterm birth prior to 35 weeks of pregnancy or major fetal and neonatal complications related to preterm birth.
Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Hydroxyprogesterone Caproate (Makena) (HRG Publication #2494)
In a testimony before the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA withdraw hydroxyprogesterone caproate (Makena) from the market because there is a lack of substantial evidence demonstrating that the drug is effective for preventing preterm birth or complications of preterm birth.
Testimony Before the FDA’s Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Montelukast (HRG Publication #2492)
In testimony before a joint meeting of the FDA’s Pediatric Advisory Committee and Drug Safety and Risk Management Committee, Public Citizen urged the committees to recommend that the FDA strengthen warnings and alert healthcare providers about the use of montelukast for the treatment of asthma and the risk of neuropsychiatric events because this risk is inadequately communicated by healthcare providers/prescribers and patients remain unaware of the risk of these adverse events.
Comments on the FDA’s Draft Guidance for Industry Entitled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework” (HRG Publication #2487)
Public Citizen finds the draft guidance overall to be woefully inadequate because its cursory content is far more focused on the nonspecific, generalized factors that the Food and Drug Administration (FDA) itself will consider when reviewing a new drug application (NDA) for an opioid, rather than providing industry with guidance as to what specific benefit and risk information should be sought out and included in future NDAs for new opioids.
Petition to the FDA to Require a Black-Box Warning for the Osteoporosis Drug Prolia (HRG Publication #2478)
Public Citizen petitioned the Food and Drug Administration (FDA) to add a black-box warning to the product labeling for the osteoporosis drug, Prolia (denosumab), to alert doctors and patients about the risk of vertebral fractures associated with cessation of the drug and need for alternative osteoporosis treatment after stopping the drug.
Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Sotagliflozin for Treating Type 1 Diabetes (HRG Publication #2473)
Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for sotagliflozin (ZYNQUISTA) for use as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes because the data from the phase 3 clinical trials presented in the NDA show that the drug causes an unacceptable eight-fold increased risk of life-threatening diabetic ketoacidosis in subjects with type 1 diabetes given the drug, compared with those given a placebo.
Petition to the FDA for a Moratorium on Approval of New Opioids or New Opioid Formulations (HRG Publication #2474)
Public Citizen petitioned the FDA to immediately impose a moratorium on approval of all new drug applications for new opioids or new opioid formulations, not to be lifted until the FDA has implemented the elements recommended by the National Academies of Sciences, Engineering, and Medicine for inclusion in a currently non-existent opioid regulatory framework that is intended to prevent a continuation of dangerous past regulatory errors that clearly have contributed to the deadly opioid crisis in the U.S.
Press Release: Responses of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen's Health Research Group, to Gottlieb Testimony on Opioids (HRG Publication #2476)
Scott Gottlieb, Food and Drug Administration (FDA) commissioner, today testified about opioids at a hearing of the U.S. Senate Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. His testimony included several misleading statements and omissions.
Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Esketamine for the Treatment of Treatment-Resistant Depression (HRG Publication #2471)
Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for the drug-device combination of esketamine (SPRAVATO) for intranasal administration for the treatment of treatment-resistant depression because the data from the clinical trials presented in the NDA failed to provide substantial evidence that the drug is effective for its proposed indication for use and there is clear evidence that the drug has serious risks of harm.
Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Sotagliflozin (HRG Publication #2466)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Sanofi’s new drug application for sotagliflozin for treatment of type 1 diabetes because the drug offers minimal benefits that do not outweigh the significantly increased risk of life-threatening diabetic ketoacidosis.
Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Romosozumab (HRG Publication #2465)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Amgen’s new drug application for romosozumab for treatment of osteoporosis in postmenopausal women at high risk for fracture because of clinical trial data linking the drug to an increased risk of serious adverse cardiovascular events.
Testimony Before the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Febuxostat (HRG Publication #2464)
In testimony before a joint meeting of the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committees to recommend that the FDA immediately remove from the market the widely used gout medication febuxostat because it poses unique, serious risks – include the risk of dying from cardiovascular disease – but offers no unique benefit. Public Citizen had requested such action in a citizen petition submitted to the agency on June 21, 2018.
Letter to the FDA Commissioner Refuting Claims Made in His Public Statement Justifying the Approval of Sufentanil Sublingual Tablets (Dsuvia) (HRG Publication #2461)
In a letter to Dr. Scott Gottlieb, the Food and Drug Administration (FDA) Commissioner, Public Citizen and the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee explain how the Commissioner misled the public regarding potential “unique” benefits of Dsuvia, a controversial, highly potent opioid pain relief medication.
Letter to the Director of Medicine at Utopia Wellness Regarding Its Promotion of Cesium Chloride for Treatment of Cancer (HRG Publication #2456)
Public Citizen sent a letter to Dr. Carlos M. Garcia, the Director of Medicine at Utopia Wellness, informing him that Public Citizen had submitted complaint letters to the Federal Trade Commission, Food and Drug Administration, and Florida Board of Medicine regarding his medical center’s dissemination of false and misleading advertisements that promote the use of cesium chloride.
Letter to the Florida Attorney General Regarding Utopia Wellness’s Dissemination of False Advertisements Promoting Cesium Chloride for Treatment of Cancer (HRG Publication #2457)
Public Citizen sent a letter to the Florida Attorney General requesting an investigation of the use of falsified scientific citations in the advertisement and promotion of an illegal heart-toxic drug for treatment of cancer by Utopia Wellness, a Florida-based medical center. The medical’s website materials misleadingly claim that cesium chloride is safe and effective for treating cancer but offers no evidence from well-controlled clinical tests to support its claims.
Op-Ed in The Washington Post Regarding the FDA’s Approval of Sufentanil Sublingual Tablets: The FDA Made the Wrong Call on This Powerful, New Opioid (HRG Publication #2459)
In a joint op-ed, Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, and Dr. Raeford Brown, chair of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee, are highly critical of the FDA’s reckless decision to approve sufentanil sublingual tablets, a new opioid that will be sold under the brand name Dsuvia.
Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding a Purportedly Abuse-Deterrent, Immediate-Release Form of Oxycodone (HRG Publication #2458)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by SpecGx for an immediate-release oral tablet formulation of oxycodone that is intended to be abuse-deterrent for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Press Release: FDA Makes Wrong Call; Super-Strong Opioid Medication Will Be Abused and Kill People (HRG Publication #2455)
The Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid, Public Citizen and the head of a key FDA advisory committee said today. The FDA gave the green light for the medication, which is called sufentanil sublingual tablet (brand name Dsuvia) and is to be used to treat moderate-to-severe acute pain in a medically supervised setting. It is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine.
Letter to the FTC Regarding Utopia Wellness’s Dissemination of False Advertisements Promoting Cesium Chloride for Treatment of Cancer (HRG Publication #2448)
Public Citizen sent a letter to the Federal Trade Commission (FTC) requesting an investigation of the use of falsified scientific citations in the advertisement and promotion of an illegal heart-toxic drug for treatment of cancer by Utopia Wellness, a Florida-based medical center. The medical’s website materials misleadingly claim that cesium chloride is safe and effective for treating cancer but offers no evidence from well-controlled clinical tests to support its claims.
Letter to the FDA Regarding Utopia Wellness’s Promotion and Use of Cesium Chloride for Treatment of Cancer (HRG Publication #2449)
Public Citizen sent a letter to the Food and Drug Administration (FDA) requesting an investigation of the promotion and use of an illegal cesium chloride drug for treatment of cancer by Utopia Wellness, a Florida-based medical center. Under current FDA policies governing pharmacy compounding, no State-licensed pharmacy or licensed physician affiliated with Utopia Wellness currently may legally compound cesium chloride.
Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Sufentanil Sublingual Tablets, a Super-Potent Opioid (HRG Publication #2451)
In a letter to the FDA, the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee joined three Public Citizen experts in urging the agency to reject Acer Pharmaceuticals’ new drug application for sufentanil sublingual tablets for treatment of moderate-to-severe acute pain in a medically supervised setting. This opioid, which is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine, would be abused and start killing people as soon as it hits the market.
Letter to the Florida Board of Medicine Regarding the Director of Medicine at Utopia Wellness, Which Promotes and Uses Cesium Chloride for Treatment of Cancer (HRG Publication #2452)
Public Citizen sent a letter to the Florida Board of Medicine requesting an investigation into the medical practice of Dr. Carlos Garcia, M.D., the Director of Medicine at Utopia Wellness. We specifically requested that the board investigate Dr. Garcia’s role in Utopia Wellness’s dissemination of false and misleading advertisements that promote the use of compounded intravenous cesium chloride as a treatment for cancer.
Comments on the FDA’s Proposal to Exclude Bumetanide, Nicardipine Hydrochloride, and Vasopressin from the 503B Bulks List for Pharmacy Compounding by Outsourcing Facilities (HRG Publication #2454)
Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to exclude bumetanide, nicardipine hydrochloride, and vasopressin from the list of bulk drug substances for which there is a clinical need under Section 503B of the Federal Food, Drug, and Cosmetic Act for pharmacy compounding by outsourcing facilities.
Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee Regarding Sublingual Sufentanil Tablets (HRG Publication #2450)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by AcelRx Pharmaceuticals for sufentanil sublingual tablets because the drug is a dangerous, high potency opioid that does not provide any unique advantages over currently available opioids, but does pose unique risks.
Petition to the FDA to Ban the Gout Medication Febuxostat (Uloric) (HRG Publication #2434)
Public Citizen petitioned the Food and Drug Administration (FDA) to ban the sale of the widely prescribed gout drug febuxostat (sold under the brand name Uloric) because use of the drug increases the risk of death compared with alternative therapies and there exist other effective medications that have been approved by the FDA for treatment of gout that have a lower risk of death.
Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Extended Release Oxycodone (HRG Publication #2435)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by Pain Therapeutics for oxycodone extended-release capsules for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Press Statement: FDA Agrees With Public Citizen, Responds to Petition by Telling Companies to Stop Marketing Over-the-Counter Benzocaine Teething Products (HRG Publication #2430)
The Food and Drug Administration (FDA) agreed with Public Citizen that over-the-counter oral health care products containing benzocaine should never be used in infants under any circumstances, even with the advice and supervision of a health care professional, because of the risk of methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen.
Press Statement: FDA’s Action to Protect Infants From Serious Blood Disorder Caused by Over-the-Counter Benzocaine Teething Products Is Long Overdue (HRG Publication #2429)
The FDA’s action today to protect infants and children from exposure to over-the-counter oral health products containing benzocaine, which can cause methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen, comes too late for some infants and children.
Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Buprenorphine Sublingual Spray (HRG Publication #2427)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject INSYS Development Company’s new drug application for buprenorphine sublingual spray for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate because the risks of the drug outweigh the benefits.
Testimony Before the FDA’s Arthritis Advisory Committee Regarding Baricitinib (HRG Publication #2418)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Eli Lilly and Company’s new drug application for baricitinib for treatment of rheumatoid arthritis because it lacks any unique benefit over the very similar FDA-approved drug tofacitinib but causes unique life-threatening harms.
Testimony Before the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Celecoxib (HRG Publication #2420)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen argued that because of the major limitations of the PRECISION trial, no meaningful conclusions can be drawn from the trial regarding the cardiovascular safety of celecoxib relative to ibuprofen and naproxen.
Letter to Congress Opposing the Proposal to Grant Two Years of Exclusivity for Certain Over-the-Counter Drugs (HRG Publication #2401)
Public Citizen expressed concerns with the proposal to grant two years of exclusivity for certain over-the-counter (OTC) drugs that is included in the September 11, 2017, House of Representatives’ discussion draft of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. While Public Citizen supports many of the measures included in the Act that would enable the Food and Drug Administration to better ensure that OTC drugs are safe and effective, we are concerned that the proposal to grant two years of exclusivity for certain OTC drugs could have negative repercussions for consumers.
Letter to Congress Opposing Legislation That Would Expand Promotion of Drugs for Unapproved Uses (HRG Publication #2400)
Public Citizen sent a letter to members of U.S. House of Representatives’ Energy and Commerce Committee urging them to oppose legislation that would further erode the restrictions on the promotion of drugs for unapproved (off-label) uses that have been approved by the Food and Drug Administration for at least one use. The bill would threaten patient health and safety by undermining the current regulatory regime for ensuring that drugs are safe and effective for each intended use.
Press Statement: Public Citizen Applauds European Medicines Agency Committee Recommendation to Ban Dangerous IV Solutions, Calls on FDA to Immediately Follow Suit (HRG Publication #2396)
Public Citizen applauds the decision by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee to recommend removing all hydroxyethyl starch (HES) intravenous (IV) solutions from the market, although this action comes nearly five years too late. The Food and Drug Administration (FDA) must now follow suit with an immediate ban on HES solutions in the U.S.
Comments to the FDA Supporting Draft Guidance Restricting Orphan Drug Designations for Pediatric Uses (HRG Publication #2395)
Public Citizen filed comments supporting a Food and Drug Administration (FDA) draft guidance, in which the FDA declared that it would no longer grant orphan drug designation to drugs for use in pediatric subpopulations of common diseases or conditions unless: 1) The disease in the pediatric population constitutes a valid orphan subset, or 2) the disease in the pediatric subpopulation is a different disease from the disease in the adult population.
Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Testosterone Undecanoate (Tlando) (HRG Publication #2394)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Lipocine’s oral testosterone undecanoate capsules (Tlando) because of serious safety concerns.
Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding A New Extended-Release Oxycodone Product (HRG Publication #2381)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees, Public Citizen urges the FDA to reject Intellipharmaceutics’ new version of oxycodone because, contrary to agency guidelines, the company has not conducted any human abuse potential studies of the drug to support a labeling claim that the drug deters intravenous abuse.
Letter to FDA Opposing Approval of Liraglutide (Victoza) for Cardiovascular Risk Reduction (HRG Publication #2380)
In a letter to the Food and Drug Administration (FDA), Public Citizen urged the FDA not to approve liraglutide (Victoza) for the additional indication of reducing cardiovascular risk in type 2 diabetes patients because the clinical trial to support such approval failed to show any benefit in the 2,500 U.S. subjects in the trial. The study only showed a significant benefit in non-U.S. subjects.
Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Reformulated Opana ER (HRG Publication #2365)
In testimony before a joint meeting of the Food and Drug Administration’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees, Public Citizen concludes that the risks of reformulated Opana ER (extended release oxymorphone) outweigh its benefits and recommends that the drug be withdrawn from the market.
Letter to Congress Opposing Legislation That Would Provide False Hope to Terminally Ill Patients (HRG Publication #2362)
Public Citizen sent a letter to members of Congress urging them to oppose three bills with various names — S. 204, H.R. 878 and H.R. 1020 —that would most appropriately each be titled the “False Hope Act of 2017.” These bills provide false hope to patients and are related to a nationwide lobbying effort funded by the Goldwater Institute, which has deceptively branded such laws as “Right to Try” legislation.
Press Statement: Trump’s Joint Address Attack on FDA Signals Complete Ignorance of Medication Approval Process (HRG Publication #2361)
President Trump’s claims that the U.S. Food and Drug Administration’s approval process for medical products is “slow and burdensome” and “keeps too many advances … from reaching those in need” reflect complete ignorance about the FDA’s current regulatory schemes for ensuring that medications and medical devices are safe and effective.
Petition to the FDA to Require a Warning About a Dangerous Drug Interaction Between Clopidogrel (Plavix) and Repaglinide (Prandin) in the Label for Both Drugs (HRG Publication #2354)
Public Citizen petitions the Food and Drug Administration (FDA) to require that the labels of the anti-clotting drug clopidogrel (Plavix) and the diabetes drug repaglinide (Prandin) warn doctors and patients that taking the drugs together can cause dangerously low blood sugar levels. The petition also asks that the drugs’ labels include a statement that the two drugs should never be taken together under any circumstances.
Press Release: FDA Wrong to Remove Chantix’s Black Box Warning Based on One Flawed Study, Sets Dangerous Precedent for Future Medication Safety (HRG Publication #2353)
The Food and Drug Administration’s removal of the black box warning on the smoking cessation medication Chantix (varenicline) sets a dangerous precedent for the future of medication safety in this country.
Testimony Before the FDA’s Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (HRG Publication #2347)
Public Citizen testified at a Food and Drug Administration (FDA) public hearing on "off-label marketing" – the pharmaceutical and medical device industry practice of marketing medications and medical devices for unapproved uses. Public Citizen experts explain that restrictions on marketing for unapproved uses are crucial to protecting patient health.
Public Citizen Urges Congress to Abandon the Dangerous 21st Century Cure Act (HRG Publication #2345)
Public Citizen and 12 other groups sent a letter to Congressional leaders urging them to abandon the dangerous 21st Century Cures Act. The legislation includes a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices and the affordability of these medical products.
Testimony Before the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Black Box Warning on the Smoking Cessation Drug Varenicline (Chantix) (HRG Publication #2340)
In testimony presented at a joint meeting of the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee discussing whether to remove a boxed warning on the smoking cessation drug varenicline (Chantix), Public Citizen urged the committees to retain the boxed warning as a critical reminder to patients and their doctors that varenicline can cause potentially life-threatening psychiatric and neurologic side effects.
Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Extended-Release Morphine Sulfate (Arymo) (HRG Publication #2332)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen opposed approval of extended-release morphine sulfate (Arymo) because of serious concerns about increased risk of abuse, given its easy manipulability and unsatisfactory performance in oral human abuse likeability studies.
Comments on the FDA’s Draft Guidances on the Prescription Requirement Under Section 503A and the Facilities Definition Under Section 503B (HRG Publication #2331)
Public Citizen supports policies contained in these two recent FDA guidances, which generally serve to clarify the line between traditional pharmacy compounding and drug manufacturing. In particular, we agree that Section 503A limits traditional compounding pharmacies from selling "office stock" in bulk to healthcare practitioners, approve of clear limitations on anticipatory compounding, and approve of the requirement that all products produced by outsourcing facilities comply with current good manufacturing practices.
Letter to U.S. Congress Conference Committee for the Comprehensive Addiction and Recovery Act (HRG Publication #2329)
Public Citizen strongly opposed a section of the House version of the Comprehensive Addiction and Recovery Act that would increase payments under Medicaid programs to opioid manufacturers for "abuse-deterrent" formulations of opioid drugs. This provision is a misguided handout to an industry that needs no additional incentives to develop and market new abuse-deterrent opioids.
Petition to the FDA to Require a Black-Box Warning for Dopamine Agonist Drugs (HRG Publication #2328)
Public Citizen petitions the Food and Drug Administration (FDA) to add stronger warnings to the labeling for dopamine agonist drugs (apomorphine, bromocriptine, cabergoline, pramipexole, ropinirole, and rotigotine) to alert doctors and patients to the risk of impulse-control problems and compulsive behaviors, including pathological gambling, hypersexuality, and compulsive shopping and eating.
Testimony Before the FDA’s Drug Safety and Risk Management Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding ALO-02 (Oxycodone/Naltrexone) (HRG Publication #2326)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen opposed approval of the combination opioid product ALO-02 because of serious concerns about increased risk of abuse, given its easy manipulability. We also urged that the FDA’s guidance for industry, “Abuse-Deterrent Opioids —Evaluation and Labeling,” be withdrawn and replaced with a regulation m
Public Citizen Statement to the FDA on Pharmacy Compounding Issues Related to Use of Bulk Substances and Office Stock (HRG Publication #2324)
In a statement to Food and Drug Administration (FDA) officials during a listening session with consumer groups, Public Citizen urged the FDA to prevent compounding using bulk drug substances that have been identified as unsafe or ineffective by FDA reviewers. We also expressed strong support for the FDA’s proposal to prevent compounding pharmacies from engaging in compounding large quantities of products for sale to healthcare providers as office stock.
Public Citizen Comments on Proposed FDA Guidance on Labeling for Biosimilars (HRG Publication #2323)
Public Citizen supports the Food and Drug Administration’s (FDA’s) proposal to keep the labels of biosimilars free of data from clinical trials used to demonstrate biosimilarity, similar to the labeling approach taken with generic drugs. We also support the FDA’s proposal to require that manufacturers of biosimilars promptly update the labeling of such products with new safety and efficacy information, as this policy will allow important new warnings to reach patients and doctors promptly.
Press Statement: Delay in Generics Labeling Rule Leaves Patients at Risk (HRG Publication #2320)
The Food and Drug Administration’s (FDA’s) postponement to April 2017 of an important patient safety rule endangers the millions of us who take prescription medications. The FDA is plainly bowing to industry pressure and, in the process, prioritizing industry profits over patient health and safety. At this point, we worry about the agency’s commitment to finalizing the rule, which it acknowledged in 2013 would improve drug safety.
Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Regarding Opioid Analgesics (HRG Publication #2316)
In testimony before a joint meeting of the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen called for legally mandated training for doctors who prescribe powerful opioid painkillers as a condition of obtaining or renewing their Drug Enforcement Agency narcotics licenses.
Letters to CMS and the Joint Commission Requesting Roll Back of Pain Assessment Requirements That Foster Dangerous Overprescribing of Opioids (HRG Publication #2314)
In an effort to reduce overprescribing of opioid pain relievers, dozens of health care organizations, medical experts and consumer advocacy groups – including Public Citizen – sent petitions today to the Joint Commission, an agency that accredits health care organizations, and to the Centers for Medicare and Medicaid Services (CMS). Petition signers are requesting changes to requirements for assessing patients’ pain that they believe foster dangerous opioid analgesic prescribing practices.
Comments on the FDA's Draft Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (HRG Publication #2295)
Public Citizen objects to the Food and Drug Administration's (FDA's) proposed interim policy that will allow outsourcing facilities to mass-produce drugs using bulk drug substances that are not currently on a list of drug shortages maintained by the FDA or on a list of bulk drug substances developed for which there is a clinical need. The proposed interim policy poses a threat to public health.
Comments on the FDA's Draft Interim Policy on Compounding Drugs Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act (HRG Publication #2294)
Public Citizen objects to the Food and Drug Administration's (FDA's) proposed interim policy that will allow pharmacies to compound drugs using bulk drug
Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Simvastatin/Ezetimibe (HRG Publication #2292)
Public Citizen opposes approval of ezetimibe in combination with simvastatin for the proposed indication of reducing the risk of cardiovascular events in patients with coronary heart disease. Results of the IMPROVE-IT study failed to provide substantial evidence to support approval for this indication.
Public Citizen Report: House Orphan Drug Proposal: A Windfall for Pharma, False ‘Cure’ for Patients (HRG Publication #2289)
In July 2015, the U.S. House of Representatives passed the 21st Century Cures Act, a bill purported to provide “help and hope for patients through biomedical innovation.” Yet in many ways the “cure” presented by the bill is a false one. For example, one provision of the bill would give an extra six months of monopoly protection to manufacturers for brand-name medications granted an additional approval to treat an orphan disease. Public Citizen’s report explains how this provision could cost U.S. taxpayers,
Letter to the FDA Urging the Agency not to Approve the New Drug Application for Lesinurad (HRG Publication #2288)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for lesinurad for treatment of hyperuricemia associated with gout because the drug offers meager clinically meaningful benefits relative to placebo for gout patients with hyperuricemia and has serious risks, including definite significant kidney toxicity and possible cardiovascular toxicity. FDA approval — with reliance on warnings in the product labeling, a risk evaluation and mitigation strategy, and postmarket
Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee Regarding Gepirone (HRG Publication #2286)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of gepirone for treatment of depression. The drug showed such poor results in clinical testing that its approval by the FDA would effectively weaken standards for approval of new antidepressants.
Testimony Before the FDA’s Antimicrobial Drugs and Drug Safety and Risk Management Advisory Committees Regarding Fluoroquinolone Antibiotics (HRG Publication #2282)
Public Citizen is concerned about the significant overprescribing of fluoroquinolones. We recommend that the Food and Drug Administration (FDA) require the addition of black-box warnings to the labels of all such antibiotics about the risk of life-threatening abnormal heart rhythms.
Testimony Before the FDA's Arthritis Advisory Committee Regarding Lesinurad (HRG Publication #2279)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for lesinurad for treatment of hyperuricemia associated with gout because the drug offers meager clinically meaningful benefits relative to placebo for gout patients with hyperuricemia and has serious risks, including definite significant renal toxicity and possible cardiovascular toxicity. As a result, the drug would cause much more harm than benefit.
Letter to California Governor Endorsing Four Bills to Regulate Psychotropic Medication Use in Foster Children (HRG Publication #2277)
Thousands of California foster children are medicated with psychotropic drugs with little oversight and without assurance that the treatments are safe and appropriate and that other, safer treatments have been tried first. Public Citizen’s Health Research Group urges the governor of California to sign Senate Bills (SBs) 238, 319, and 484, and to direct his staff to resolve any outstanding issues on SB 253, which, together, address and more stringently regulate this dangerous medication overuse.
Coalition Letter to U.S. Senate Finance Committee Calls for Release of Findings of Investigation of Opioid Makers (HRG Publication #2275)
In a letter sent to the U.S. Senate Finance Committee, 36 physician groups, addiction agencies and consumer advocacy organizations, including Public Citizen, request public release of the results of a 2012 investigation by the committee into financial ties between producers of pain medications and organizations that aggressively promote the medications.
Press Statement: Senate Should Reject President’s Nominee to Be the Next FDA Commissioner (HRG Publication #2276)
The Senate should reject President Barack Obama’s nomination of Dr. Robert Califf to be the next commissioner of the U.S. Food and Drug Administration (FDA). His nomination undoubtedly comes as welcome news to the pharmaceutical and medical device manufacturers, but is bad news for patients and public health.
Press Release: FDA's Big Mistake: Expect Flibanserin to Be Pulled From the Market in a Few Years (HRG Publication #2272)
The U.S. Food and Drug Administration’s (FDA's) decision to approve flibanserin as a treatment for women with hypoactive sexual desire presents serious dangers to women, with little benefit, and recklessly disregards the worrisome risk information in the agency's briefing package to the advisory committees that met on June 4 to review the drug.
Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Alirocumab (HRG Publication #2263)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for alirocumab for treatment of lipid disorders because there is insufficient information to evaluate that benefit-risk balance of the drug.
Petition to FDA Concerning the Inappropriately Expanded Approval of the Sleep Drug Tasimelteon (Hetlioz) (HRG Publication #2265)
Public Citizen petitions the Food and Drug Administration (FDA) to reverse its decision to expand the approval of the sleep medication tasimelteon (Hetlioz) to patients who are not blind, as the relevant clinical trials for the drug were conducted only in totally blind patients with non-24-hour sleep-wake disorder. The petition also requests that FDA include certain animal toxicity data in the drug’s label.
Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Evolocumab (HRG Publication #2264)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for evolocumab for treatment of lipid disorders because there is insufficient information to evaluate the benefit-risk balance of the drug.
Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Flibanserin (HRG Publication #2262)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of the new drug application for flibanserin for treatment of hypoactive sexual desire disorder in premenopausal women. The FDA previously rejected approval of the drug in 2010 and 2013. There is now considerably more evidence that the drug’s risks outweigh its benefits.
Statement on FDA’s Denial of Public Citizen’s 2012 Petition for a Black Box Warning Recommending Against Combination Therapy with ACE Inhibitors, ARBs, and Aliskiren (HRG Publication #2252)
The U.S. Food and Drug Administration’s (FDA) refusal to require a black box warning against the combined use of three widely used classes of blood pressure medications is ill-advised.
Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding the Diabetes Drug Saxagliptin (HRG Publication #2253)
The Food and Drug Administration (FDA) should withdraw saxagliptin from the market because the large postmarket SAVOR trial demonstrated that the drug has unacceptable cardiovascular risks.
Letter to FDA on the Off-Label Promotion of Several Diabetes Drugs (HRG Publication #2250)
Public Citizen calls on the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion to halt the dissemination of direct-to-consumer advertisements for five prescription drugs approved only for the treatment of Type 2 diabetes. The ads promote the drugs for the off-label uses of weight loss and blood pressure reduction. Public Citizen also calls on the agency to fine the companies responsible for issuing the ads, an action that it has never before taken in response to such violative ads.
Testimony Before the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee Regarding Deoxycholic Acid Injection (HRG Publication #2243)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of deoxycholic acid injection for cosmetic procedures to remove chin fat because the limited benefits of the drug are outweighed by its risks. In particular, the clinical trials of the drug demonstrate that it cause nerve damage and difficulty swallowing.
Testimony Before a Joint Meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Fluticasone Furoate/Vilanterol (Breo Ellipta) for Asthma (HRG Publication #2248)
The FDA should not approve the combination therapy, fluticasone furoate/vilanterol (Breo Ellipta) for the treatment of asthma, because the combination medicine may be dangerous in adolescents and little is known about its safety in adults. Breo Ellipta should not be approved for asthma until a large, adequately designed clinical trial is completed demonstrating that the combination therapy is as safe as the single ingredient fluticasone furoate for both adult and adolescent patients.
Petition to the FDA to Ban All Oral Forms of the Anti-Fungal Drug Ketoconazole (HRG Publication #2241)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately require that the oral forms of the antifungal agent ketoconazole be removed from the market because the drug’s risks of fatal liver failure and adrenal insufficiency, and its numerous drug interactions, outweigh its limited benefits in treating fungal infections.
Testimony before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Desmopressin for Nocturia (HRG Publication #2235)
Public Citizen strongly oppose Food and Drug Administration (FDA) approval of Nocdurna (desmopressin) — a drug already twice rejected by the FDA — for treatment of nocturia due to nocturnal polyuria in adults because the drug’s serious risks far outweighs its meager clinical benefits.
Testimony before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee Regarding Epidural Steroid Injections (HRG Publication #2233)
Public Citizen urges the committee to recommend that the Food and Drug Administration (FDA) require a boxed warning and contraindication against the use of steroids for epidural injection, based on the fact that there is a class-wide risk of rare but catastrophic adverse neurologic events that cannot be eliminated through current mitigation strategies. This risk far outweighs any limited benefits of such injections.
Letter to the Editor Published in Clinical Pharmacokinetics: Hepatotoxicity of Alogliptin (HRG Publication #2228)
Public Citizen criticizes a recent article published in Clinical Pharmacokinetics that concluded that “no hepatotoxicity has been reported” during the development of the diabetes drug alogliptin. However, after analyzing phase 2 and 3 pre-approval trials of alogliptin and post-marketing surveillance data for the drug from Japan, the Food and Drug Administration and European Medicines Agency concluded that the drug’s potential hepatotoxicity warranted inclusion of warning language in the drug’s label.
Petition to the FDA Requesting a Stronger Boxed Warning and New Restrictions on the Use of Varenicline (Chantix) (HRG Publication #2225)
Public Citizen joins four other organizations in petitioning the Food and Drug Administration (FDA) to require a more informative and comprehensive Black Box Warning for the smoking cessation drug varenicline (Chantix). The petition also asks that the FDA add restrictions to the Indications section of the product label warning against the drug’s use by individual.
Letter to HHS Secretary Opposing FDA Guidance for Distribution of Risk Information (HRG Publication #2226)
The U.S. Food and Drug Administration (FDA) should release all comments to the public that were submitted about a recent proposal to allow the pharmaceutical industry to circumvent labeling rules and tell doctors that its products have fewer risks than those described in FDA-approved labeling, Public Citizen said in a letter to Secretary of Health and Human Services Sylvia Mathews Burwell today. Public Citizen calls on the Secretary to order the FDA to withdraw the dangerous proposal.
Testimony Before the FDA's Pulmonary-Allergy Drugs Advisory Committee on Tiotropium (Spiriva Respimat) (HRG Publication #2212)
Public Citizen opposes the Food and Drug Administration’s approval of tiotropium (Spiriva Respimat) because the drug (1) offers no unique advantages over the currently available Spiriva HandiHaler; and (2) appears to have a greater risk of fatal myocardial infarction than Spiriva HandiHaler.
Testimony before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Liraglutide for Weight Loss (HRG Publication #2219)
Public Citizen strongly opposes the approval of liraglutide (Saxenda) for weight loss because the drug, currently approved for type 2 diabetes, has already been shown to be toxic at a lower dose than that which is being considered for weight loss, while conferring only marginal benefits on weight reduction and no proven long-term health benefits.
Petition to the FDA to Not Allow Marketing of Over-The-Counter Benzocaine Products for Teething in Infants (HRG Publication #2209)
Public Citizen petitions the Food and Drug Administration to no longer allow over-the-counter (OTC) benzocaine products to be marketed for treating teething in infants and toddlers because they can prompt a rare but deadly adverse reaction. In addition, the agency should require a warning about this adverse reaction on all other OTC benzocaine products intended for use in older children and adults.
Statement: Another Reckless FDA Action: Approval of Suvorexant (Belsomra) (HRG Publication #2213)
The U.S. Food and Drug Administration (FDA) has approved suvorexant (brand name: Belsomra), a dangerous and habit-forming sleep medication. The lowest doses of suvorexant were approved despite having never been tested in large clinical studies that are a standard requirement for all modern medication – and dosage – approvals, while the higher doses demonstrated only marginal benefits and caused serious next-day driving impairment.
Press Release: FDA Draft Guidance Would Let Pharmaceutical Industry Tell Doctors Medications Are Safer Than They Really Are (HRG Publication #2214)
The U.S. Food and Drug Administration (FDA) recently issued draft guidance that would let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approved labeling. This is discussed by Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, in a Journal of the American Medical Association Internal Medicine article.
Statement: Contrasting Actions by Health Canada and the FDA on Testosterone (HRG Publication #2208)
In a response to the Food and Drug Administration’s (FDA’s) denial of a petition to add a black-box warning to the product labels of all testosterone-containing drugs on the market in the U.S., Public Citizen notes that Health Canada took drastically different action in the same week.
Acute Pancreatitis With Liraglutide: An analysis of MedWatch adverse event reports submitted to the Food and Drug Administration (HRG Publication #2204)
A new Public Citizen study referenced in a letter sent to the U.S. Food and Drug Administration (FDA), and posted online, reinforces the case that the diabetes drug liraglutide can cause pancreatitis and should be banned immediately by the FDA.
Testimony Before the FDA’s Analgesic and Anesthetic Drug Products Advisory Committee Meeting on Moxduo (HRG Publication #2194)
Public Citizen strongly opposes the approval of Moxduo, a drug combination containing the opioids morphine and oxycodone. Moxduo was shown to be no more effective or safer than either morphine or oxycodone alone for treating acute pain. HRG also argues that approval of this drug could further contribute to the epidemic of opioid abuse in the U.S.
Letter to Senator Joe Manchin Urging Him to Investigate FDA’s Decision to Approve Dangerous High-Dose Opioid (HRG Publication #2191)
Public Citizen commended Senator Manchin for his efforts to (a) overturn the reckless decision by the Food and Drug Administration (FDA) to approve the dangerous, high-dose, non-tamper-resistant opioid drug Zohydro ER; and (b) develop legislation that would target such seriously flawed decision-making by the agency.
Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding the Drug Serelaxin (HRG Publication #2192)
Public Citizen strongly opposes the approval of serelaxin for acute heart failure because it has exceedingly marginal, if any, benefits on subjective, transient, shortness of breath symptoms and no proven benefits on any objective cardiovascular outcomes. The FDA should follow the lead of a key committee of the European Medicines Agency and the recommendation of its own clinical reviewer in rejecting the drug unless it ultimately demonstrates a clinically meaningful benefit in a larger, ongoing trial.
Letter to the FDA Protesting (HRG Publication #2189)
Letter to FDA protesting decision announced today to approve a long-lasting testosterone injection drug, Aveed.
Letter to the FDA Opposing Approval of the New Drug Application for Droxidopa (HRG Publication #2182)
In a letter to the Food and Drug Administration (FDA) Public Citizen urges the agency to not approve the new drug application for droxidopa for treatment of patients with neurogenic orthostatic hypotension. There is insufficient evidence that the drug is effective or that the benefits of its use outweigh the risks.
Petition to the FDA for Black Box Warnings on All Testosterone Products (HRG Publication #2184)
Public Citizen petitions the Food and Drug Administration to add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs presently on the market in the U.S.
Testimony before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding the Drug Cangrelor (HRG Publication #2183)
Public Citizen strongly opposes approval of the anti-platelet drug cangrelor for use in patients undergoing coronary artery stenting procedures and for patients who need an IV anti-platelet drug while awaiting surgery. The clinical trials failed to show that cangrelor is effective for these uses, and the design of these trials was unethical because subjects assigned to the control group received substandard anti-platelet management.
Testimony before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding the Drug Cangrelor (HRG Publication #2254)
Public Citizen strongly opposes approval of the anti-platelet drug cangrelor for use in patients undergoing coronary artery stenting. The key clinical trial failed to show that cangrelor is as safe and effective as other available treatments for these uses, and the design of the trial was unethical because subjects assigned to the control group received substandard anti-platelet management. The FDA again should reject the drug, as it did one year ago.
Testimony to FDA Endocrinologic and Metabolic Drugs Advisory Committee on Dapagliflozin for Treatment of Type 2 Diabetes Mellitus (HRG Publication #2173)
Public Citizen urges the agency not to approve dapagliflozin, a member of a new chemical class of drugs to treat type 2 diabetes mellitus, because it is no more effective than a similar diabetes drug, canagliflozin, approved by the FDA in March 2013, but does appear to pose additional safety hazards not seen with canagliflozin, including risks of bladder cancer and liver toxicity.
Letter to the FDA Calling for Public Disclosure of Meta-Analyses Performed by the Agency (HRG Publication #2174)
Public Citizen urged the Food and Drug Administration (FDA) to disclose to the public all currently completed and future FDA meta-analyses of randomized controlled clinical trials that concern the safety of FDA-regulated human drugs and biologics. In addition to disclosure of the meta-analyses, results of the individual studies that comprise the meta-analyses, and all other related data, also need to be disclosed.
Letter to FDA Commissioner Margaret Hamburg Criticizing Agency Messages Endorsing Compounded Drugs Made by Outsourcing Facilities (HRG Publication #2175)
Public Citizen urged the Food and Drug Administration (FDA) to stop making misleading statements that could lead health care providers to treat patients with compounded drugs produced by outsourcing facilities without understanding that they are not as safe as FDA-approved drugs.
Presentation on Pharmacy Compounding before the Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference (HRG Publication #2176)
Public Citizen Attorney Sarah Sorscher spoke on pharmacy compounding at a conference focused on enforcement by the Food and Drug Administration (FDA). Public Citizen has pushed heavily for the FDA to respond more aggressively when compounding pharmacies violate federal law. The presentation includes several examples of areas where the FDA failed to enforce federal law against compounding pharmacies in the past.
Statement: Johnson & Johnson Settlement Nothing New for Company; Small Fine Unlikely to Prompt Change in Behavior (HRG Publication #2168)
The announcement that Johnson & Johnson will pay $2.2 billion in criminal and civil fines to the federal and state governments is the latest in a long line of multibillion-dollar health fraud settlements. Despite the seemingly large sums, the fines imposed on pharmaceutical companies for dangerous and illegal conduct pale in comparison to the profits generated from such activity.
Statement: FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety (HRG Publication #2169)
The Food and Drug Administration (FDA) today issued a proposed rule to revise regulations on generic drug labeling, responding to a 2011 Public Citizen petition. When finalized, the rule will allow generic drug manufacturers to update their products’ labeling to include recently acquired safety information without prior agency approval, which current FDA regulations do not allow them to do.
Public Citizen Supports European Policy on Publication of Clinical Trials Data (HRG Publication #2163)
Public Citizen writes to the European Medicines Agency (EMA), the European Union agency that carries out premarket approval for drugs, to support the EMA’s proposed policy that would provide for the publication of clinical-trial data submitted to the EMA in the future. This policy will enable independent expert groups to review the benefits of and risks of EMA-approved drugs, which are often also approved for marketing in the United States.
Statement: An Inexcusable Delay: FDA Finally Approves Black Box Warning for Antibiotic Tygacil, as Called for by Public Citizen (HRG Publication #2162)
Public Citizen welcomes the announcement by the Food and Drug Administration (FDA) that the agency has approved a new black box warning for the antibiotic tigecycline (brand name: Tygacil). The warning indicates that clinical trials have found an increased risk of death with tigecycline in comparison to other antibiotics and that the drug should thus be used only when alternative treatments are not suitable. Public Citizen first requested this warning in a November 2011 citizen petition to the FDA.
Statement: Proposed Compromise Compounding Bill Threatens Patient Safety by Allowing ‘Outsourcing Facilities’ to Manufacture Drugs Without New Drug Approval (HRG Publication #2161)
A year after a deadly disease outbreak linked to tainted compounded drugs, a newly proposed Congressional bill would make it easier for companies like the one behind the outbreak to manufacture substandard drugs without Food and Drug Administration approval, under the guise of pharmacy compounding.
Statement: FDA Action Benefits Industry, Perpetuates Unsafe Use of Opioid Pain Medications (HRG Publication #2158)
The Food and Drug Administration (FDA) recently announced new safety requirements for certain opioid pain medications. The action represents a small step in the right direction, but it ultimately fails to adequately ensure the safety of chronic pain patients, and it favors the interests of the pharmaceutical industry over those of the public’s health.
Public Citizen Petition to FDA to Warn Against Prolonged Use of Clopidogrel (Plavix) in Cardiac-Stent Patients Because of Lethal Side Effects, No Benefit (HRG Publication #2149)
Public Citizen petitions the Food and Drug Administration to warn patients and doctors that taking the widely prescribed drug clopidogrel (brand name: Plavix) for more than a year after having a drug-eluting stent implanted can lead to potentially fatal bleeding without providing further benefits.
Letter to HHS Secretary Sebelius Regarding Specialty Compounding (HRG Publication #2148)
Public Citizen urges Secretary of Health and Human Services Kathleen Sebelius to direct the Food and Drug Administration (FDA) to seek an injunction against Specialty Compounding, a Texas compounding pharmacy cited by FDA inspectors for multiple sterility concerns in March 2013.
Public Citizen Opposes Approval of Drug with Liver Toxicity Risks at FDA Advisory Committee Meeting (HRG Publication #2147)
In testimony before the Food and Drug Administration, Public Citizen spoke against approval of the drug tolvaptan for use in polycystic kidney disease, citing its liver toxicity risks and that it does not meet essential elements of efficacy needed for drug approval.
Public Citizen Comments for House Regarding Compounding Pharmacy Legislation (HRG Publication #2142)
Public Citizen expresses our grave concerns with all three pending pieces of legislation on pharmacy compounding. There may be significant differences between these three proposals, but all of them put patients at risk by permitting compounding pharmacies to engage in drug manufacturing activity without seeking a new drug approval from the Food and Drug Administration (FDA) or complying with important federal drug labeling requirements.
Testimony to the FDA Drug Safety and Risk Management Advisory Committee on the Restrictions on the Use of Lotronex (HRG Publication #2141)
Public Citizen recommends that restrictions on Lotronex (alosetron) be tightened, rather than loosened, due to its high risk of life-threatening adverse reactions compared with its marginal benefits.
Testimony to FDA Drug Safety and Risk Management and Endocrine and Metabolic Drugs Advisory Committees Regarding Rosiglitazone Safety (HRG Publication #2134)
Public Citizen argues that not only should the current restrictions on the use of the diabetes drug rosiglitazone (Avandia) not be lifted, the drug should be removed from the U.S. market given its unique risks and the absence of any unique benefits. Among older patients with diabetes, rosiglitazone is associated with a significantly higher risk of heart failure and death compared to pioglitazone.
Public Citizen to Congress: New Bill on Pharmacy Compounding a Major Step Backward for U.S. Drug Safety (HRG Publication #2127)
Public Citizen opposes the proposal to create a new regulatory class of drug manufacturers, confusingly called “compounding manufacturers,” that would be exempt from federal premarket approval and related labeling requirements. The bill on pharmacy compounding, S. 959, introduced in the Senate on May 15, offers no significant improvement over the draft.
Letter to the Editor of The Washington Post Criticizing a Recent Editorial Lauding U.S. Senate Legislation on Compounding Pharmacies (HRG Publication #2126)
In a letter to the editor of The Washington Post, Public Citizen strongly criticized the May 6 editorial “Concocting a cure” supporting draft U.S. Senate legislation on pharmacy compounding. The bill would be a significant step backward for drug safety in the U.S.
Public Citizen’s Comments on Senate HELP Committee Draft Proposal for Regulatory Oversight of Compounding Pharmacies (HRG Publication #2121)
Public Citizen expresses grave concerns with the Committee’s draft legislative proposal which will weaken existing laws governing drug manufacturing by creating an entirely new regulatory class of drug manufacturers that would be subject to substandard requirements for ensuring the efficacy, safety, quality, and labeling of drugs.
Letter to FDA Demanding Explanation for Dangerous Delay Between Identifying Problems and Public Recall of Potentially Contaminated Products Distributed by Balanced Solutions Compounding Pharmacy (HRG Publication #2117)
Public Citizen requests an explanation for the unacceptable one-month delay between the Food and Drug Administration’s (FDA’s) inspection of Axium Healthcare Pharmacy (dba Balanced Solutions Compounding Pharmacy), which was finished on March 15, 2013 and identified serious quality control problems related to the production of sterile drugs, and the subsequent nationwide voluntary recall of all lots of sterile products compounded by this pharmacy on April 17, 2013.
Letter to the Editor of The Washington Post Criticizing FDA for its Failure to Regulate Drug Manufacturing by Compounding Pharmacies (HRG Publication #2116)
In a letter to the editor of The Washington Post, Public Citizen responded to the April 12 front-page article “FDA finds safety problems at specialized pharmacies.” The Food and Drug Administration must ensure that companies that engage in drug manufacturing under the guise of pharmacy compounding either scale down their operations or adhere to current federal regulations governing drug manufacturing.
Testimony to the FDA’s Advisory Committee on Reproductive Health Drugs on Nasal Calcitonin for Osteoporosis (HRG Publication #2101)
Calcitonin nasal spray, prescribed to treat osteoporosis since 1994, should be removed from the market because is not very effective for preventing fractures and may cause cancer and other serious side effects.
Testimony to the FDA's Advisory Committee on Reproductive Health Drugs on gabapentin for menopausal symptoms (HRG Publication #2099)
Public Citizen strongly opposes the Food and Drug Administration’s (FDA’s) approval of gabapentin for treatment of menopause-related vasomotor symptoms (VMS, which includes hot flashes and flushing) due to the drug's questionable benefits and well-established risks.
Testimony to the FDA's Advisory Committee on Reproductive Health Drugs on paroxetine for menopausal symptoms (HRG Publication #2100)
Public Citizen strongly opposes the Food and Drug Administration’s (FDA’s) approval of paroxetine for treatment of menopause-related vasomotor symptoms (VMS, which includes hot flashes and flushing) due to the drug's questionable benefits and well-established risks.
Keynote Address by Sidney Wolfe, MD at “Selling Sickness” Conference (HRG Publication #2097)
Public Citizen’s presentation to the “Selling Sickness” conference regarding the drug companies’ strategy of promoting dangerous products to treat routine ailments and the FDA’s collusion in this practice.
Testimony to Drug Safety and Risk Management Advisory Committee on Overprescription of Hydrocodone (HRG Publication #2092)
Ninety-nine percent of the hydrocodone in the world is manufactured and used in the United States – evidence that hydrocodone products are being overprescribed and should be severely restricted, Public Citizen told the FDA today.
Press release: FDA Rejects Petition to Ban Aricept 23: Did Drug Companies, FDA Collude in Approving Dangerous Alzheimer’s Drug?
By rejecting Public Citizen's petition to ban Aricept-23, the FDA has sided with Pfizer to allow a dangerous drug to remain on the market.
Commentary on CNN.com: Deadly Meningitis Outbreak was Completely Avoidable
In an invited commentary, Public Citizen reports that the ever-expanding outbreak of life-threatening fungal meningitis in back pain patients linked to steroid injections prepared by a compounding pharmacy, which so far has sickened at least 214 people and killed 15 in 15 states, is a public health catastrophe. What is particularly tragic for those who have been sickened or killed by the tainted drug and for their loved ones is that this situation was completely avoidable.
Steroid-Linked Fungal Meningitis Outbreak Reveals Serious Failures in the Oversight of Compounding Pharmacies
The widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to steroid injections highlights the failure of the Food and Drug Administration’s (FDA’s) regulatory oversight of drugs prepared and sold by compounding pharmacies.
Petition to the FDA for Black Box Warnings on ACE Inhibitors, ARBs, and Aliskiren (HRG Publication #2075)
Public Citizen petitions the Food and Drug Administration to place black box warnings on all ACE inhibitors, ARBs, and aliskiren, warning against the use of the medications in combination with one another. The drugs, given individually, are effective in treating high blood pressure, but when used in combination, cause life-threatening side effects with no added benefit.
Lawsuit to prevent dangerous Alzheimer's treatment (HRG Publication #2068)
Public Citizen files suit to compel The Food and Drug Administration (FDA) to act on our petition calling on the agency to stop allowing the drug Aricept to be marketed at doses that can cause severe – and even fatal – side effects.
Supplement to Petition to FDA for Tigecycline Black Box Warning (HRG Publication #2033)
Public Citizen submitted additional data supporting its October 2011 petition to the FDA to immediately require the addition of a black box warning to the label for tigecycline (Tygacil) indicating that the antibiotic: a) has an increased risk of death in comparison to many other antibiotics when used to treat a variety of serious infections; and b) should be used only as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.
Letter to the Senate HELP Committee Opposing Draft Legislation Proposing Incentives for Antibiotic Development (HRG Publication #2017)
Public Citizen comments on the March 29 discussion draft of legislation amending the Federal Food, Drug, and Cosmetic Act to incentivize new antibiotic development that was prepared by the Senate Committee on Health, Education, Labor, and Pensions that would provide drug companies with large financial incentives to develop new antibiotics and mandate that the Food and Drug Administration (FDA) review these drugs more rapidly.
Letter to the FDA Opposing Resumption of Clinical Trials Testing Anti-Nerve Growth Factor Drugs (HRG Publication #2018)
The Food and Drug Administration (FDA) should reject the recommendation of the Arthritis Advisory Committee to resume clinical development of anti-nerve growth factor drugs for management of chronic pain. Further human studies of these drugs would be unethical and not approvable under FDA regulations for the protection of human subjects because the risks outweigh the potential benefits to subjects and the importance of the knowledge that is expected to result.
Petition to Ban Diabetes Drug Liraglutide (Victoza) (HRG Publication #2020)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately remove from the market the diabetes drug liraglutide (Victoza; Novo Nordisk) because the known increased risks of thyroid cancer and pancreatitis outweigh any documented clinical benefits.
Testimony Before FDA Endocrinologic and Metabolic Drugs Advisory Committee Meeting on Cardiovascular Risk Assessment of Obesity Drugs (HRG Publication #2012)
A dangerously low approval standard for diet drugs has created a history of recalls, injuries, and needless deaths.
Substantially Unsafe: Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened (HRG Publication #2006)
The medical device industry is engaging in a massive lobbying effort designed to weaken already lax oversight and speed already quick review of its high-risk products, a new Public Citizen study finds.
Testimony to the FDA’s Arthritis Advisory Committee on Safety Issues Related to Anti-Nerve Growth Factor Agents (HRG Publication #2007)
We strongly urge the Food and Drug Administration (FDA) to permanently suspend the clinical development of these anti-nerve growth factor (anti-NGF) agents for the treatment of pain because of the dramatic safety signal seen in clinical studies of these agents demonstrating an unusually high incidence of rapid joint destruction.
Letter to FDA on Wingspan Stent System (HRG Publication #1998)
Public Citizen states that FDA should not categorize future investigations using the Wingspan Stent System or similar systems as Category B, because it is a class III device and underlying questions of safety and effectiveness have not been resolved.
Letter to Medicare and Medicaid on Wingspan Stent System (HRG Publication #1999)
Public Citizen urges the Centers for Medicare and Medicaid Services to withdraw coverage for the Wingspan Stent System and similar systems, because new data reveals that these systems provide no benefits and dramatically increase the risk of stroke or death.
Statement to the Subcommittee on Health of the House Energy and Commerce Committee Advocating for Legislation to Improve Medical Device Safety (HRG Publication #2000)
Public Citizen's Health Research Group urges Subcommittee on Health of the House Energy and Commerce Committee members to support bills such as H.R. 3847, the Safety of Untested and New Devices Act (the SOUND Devices Act) of 2012, that would improve patient safety — rather than threaten it.
Testimony Before FDA Endocrinologic and Metabolic Drugs Advisory Committee Meeting on Qnexa (HRG Publication #2001)
The new weight loss drug combination phentermine and topiramate (Qnexa) causes serious adverse events and should again be rejected by the FDA.
Comments to FDA on Direct-to-Consumer Drug Advertisements (HRG Publication #2002)
Direct-to-consumer advertising should be carefully regulated and required to include clear, specific, and easy-to-understand audio and visual explanations of the product’s risks and benefits, along with the risks and benefits of alternative therapies. A recent FDA-funded study on distraction in direct-to-consumer drug advertising was not well-designed to detect the effects of distraction on consumer comprehension of risks, and cannot be used as a guide for policymaking.
Letter to the FDA Opposing Reclassification of Cranial Electrotherapy Stimulator Devices (HRG Publication #2003)
In a letter to the Food and Drug Administration, Public Citizen opposed the reclassification of cranial electrotherapy stimulator devices—which are indicated for the treatment of depression, anxiety, and insomnia—from the high-risk class III category to the moderate-risk class II category.
Letter to CMS and OHRP Opposing Proposal to Require Medicare Beneficiaries Undergoing an Aortic Valve Replacement Procedure to Participate in Research Without Their Informed Consent (HRG Publication #2004)
In a letter to the Centers for Medicare and Medicaid Services (CMS) and the Office for Human Research Protections, Public Citizen objected to CMS’s proposal to require Medicare patients to participate in research as a condition of coverage for transcatheter aortic valve replacement because the policy as proposed fails to comply with the requirements for obtaining informed consent for research.
Letter to OHRP Regarding Testing the Drug Canakinumab in Diabetic Children Without Adequate Informed Consentor Parental Permission (HRG Publication #2005)
Follow-up letter to the Office for Human Research Protections regarding a clinical study testing the drug canakinumab in children with type I diabetes failed to satisfy the requirements of HHS regulations regarding informed consent for research.
Letter to FDA Opposing Approval of Loxapine Inhalation Powder (Adasuve) (HRG Publication #1997)
Public Citizen’s Health Research Group strongly opposes FDA approval of loxapine (Adasuve) inhalation powder for treatment of schizophrenia or bipolar I disorder in adults due to no evidence from clinical trials that it offers any benefits over currently-available treatments and that it can cause life-threatening pulmonary toxicity.
Testimony on Ethinyl Estradiol/Norelgestromin (Ortho-Evra) (HRG Publication #1989)
If the Ortha Evra patch has no unique benefits and, relative to equally effective oral contraceptives with lower estrogen doses, has a higher risk of blood clots, there is no reason to leave it on the market. Although prescriptions have dropped markedly in the past seven years, more than a million prescriptions a year are still filled for the patch. Women using these prescriptions are at increased risk with no significant, documented benefit.
Removal of Consumer Advocate From Dec. 8 Advisory Committee Meeting Is Bad Policy (HRG Publication #1987)
Less than 48 hours from the beginning of Thursday’s Food and Drug Administration (FDA) advisory committee meeting to discuss the risks of blood clots from the birth control pills Yaz and Yasmin, Health Research Group director Dr. Wolfe was notified in a phone call from FDA’s Office of Advisors and Consultants that he could not participate as a member of the Drug Safety and Risk Management Advisory Committee in that meeting because of what the agency calls his “intellectual conflict of interest.”
Statement: FDA’s Rejection of Public Citizen’s Petition to Ban Rosiglitazone (Avandia) Translates to More Harm to Patients (HRG Publication #1985)
Late yesterday, the FDA faxed Public Citizen its letter rejecting our October 30, 2008 petition in which we asked the FDA to ban rosiglitazone (Avandia) because its benefits were greatly outweighed by its multiple risks, including increased heart attacks, heart failure, fractures, vision-threatening macular edema and other serious problems.
Petition Requesting Black Box Warning on Tigecycline (Tygacil) (HRG Publication #1977)
Public Citizen petitions the Food and Drug Administration to immediately require the addition of a black box warning to the label for tigecycline (Tygacil) indicating that the antibiotic: a) has an increased risk of death in comparison to many other antibiotics when used to treat a variety of serious infections; and b) should be used only as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.
Letter to FDA Urging Rejection of Florbetapir F18 Injection (Amyvid) Based on Newly Published Expert Analysis (HRG Publication #1975)
In an editorial just published on-line in the European Journal of Nuclear Medicine and Molecular Imaging, experts in the field of PET neuroimaging have identified fundamental problems with the results of studies cited by Avid Pharmaceuticals in its New Drug Application (NDA) for Florbetapir F18 Injection (Amyvid).
Letter to FDA Opposing Approval of Rivaroxaban (Xarelto) for Anticoagulation Therapy in Patients With Atrial Fibrillation (HRG Publication #1974)
We strongly oppose FDA approval of Johnson & Johnson’s NDA for rivaroxaban for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a condition for which two proven therapies already exist.
Letter to FDA Opposing Approval of Deferiprone (HRG Publication #1973)
We strongly oppose FDA approval of ApoPharma’s NDA for deferiprone for treatment of patients with transfusional iron overload when current chelation therapy is inadequate because the data presented by the sponsor in support of the NDA were grossly insufficient and fail to demonstrate that deferiprone is safe and effective in the intended patient population.
Testimony Regarding Bisphosphonates (HRG Publication #1970)
Long-term use of bisphosphonates for the prevention of osteoporotic fractures must be limited to 5 years, and the indication for bisphosphonate treatment for osteopenic women must be removed, unless the patient has a significant 10-year fracture risk as determined by the World Health Organization’s (WHO) FRAX algorithm.
Testimony on Non-Absorbable Synthetic Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (HRG Publication #1969)
We endorse the FDA’s belated proposal to reclassify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP to class III and require PMA evaluations, but this action alone is insufficient.
Petition Regarding Generic Drug Labeling (HRG Publication #1965)
Public Citizen requests that the FDA authorize generic drug manufacturers to revise generic drug labeling through the changes-being-effected (CBE) and prior-approval-supplement (PAS) procedures.
Petition Urging FDA to Add Warnings to Proton Pump Inhibitors (HRG Publication #1964)
Public Citizen petitions the FDA to immediately add black box warnings and other safety information concerning several severe risks to the product labels of all proton pump inhibitors (PPIs) presently on the market in the U.S. In addition, the serious nature of so many of these adverse reactions also mandates the requirement for FDA-approved patient Medication Guides, none of which exist now, for all of these drugs.
Petition Requesting Warnings on the Labels of Glucocorticosteroids (HRG Publication #1958)
The FDA should immediately require that the labels for all brands of prednisone and other glucocorticosteroids currently on the market in the U.S. be revised to include central serous chorioretinopathy as one of the ophthalmic adverse reactions reported with these medications if not already included. The FDA should also ensure that other important information regarding the use and safety of these medications is presented in a consistent manner across all labels.
Testimony on Dapagliflozin (HRG Publication #1957)
A drug proposed to treat patients with diabetes should not be approved because it has serious risks and no evidence of clinical benefit.
Testimony on ILARIS® (Canakinumab) (HRG Publication #1951)
We oppose the Food and Drug Administration’s (FDA) approval of canakinumab, a potent immunosuppressant agent, for the treatment of patients with gouty arthritis attacks because the drug has serious, life-threatening risks that far outweigh the drug’s clinical benefits, which are limited primarily to relief of pain from acute gout flares in this patient population.
Petition to Ban 23 Milligram Dose of Donepezil (Aricept) (HRG Publication #1950)
The 23 milligram dose of donepezil (Aricept), which is used to treat moderate or severe cases of Alzheimer’s disease, should be removed from the market immediately because of its risk of serious adverse effects and its lack of effectiveness.
Petition to Ban Orlistat (Alli, Xenical) (HRG Publication #1942)
Public Citizen, petitions the FDA to immediately ban both the prescription drug, Xenical (orlistat; Hoffman-La Roche), and the over-the-counter (OTC) drug, Alli (orlistat; GlaxoSmithKline), because they expose patients to serious risks that greatly outweigh their minimal clinical benefits.
Letter to FDA on Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1938)
These comments from the Public Citizen Health Research Group are being submitted in follow-up to our testimony presented at the March 8, 2011 meeting of the Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) regarding the drug indacaterol maleate (Arcapta™ Neohaler™).
Letter to OHRP on Unethical Trials of Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1939)
We hereby request that the Office for Human Research Protections (OHRP) conduct a compliance oversight evaluation of several unethicals trials of indacaterol maleate (Arcapta Neohaler)
Letter on Failure to Warn U.S. Doctors and Patients of Zoledronic Acid (Reclast) Dangers (HRG Publication #1936)
In order to adequately protect the public health, the FDA must immediately require that Novartis issue a “Dear Doctor Letter” to all physicians in the U.S. that communicates the same information provided to Canadian health care professionals on October 12, 2010. In addition, the FDA should issue an alert to patients in this country similar to the October 14, 2010 alert in Canada.
Testimony on Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1935)
In the interests of protecting the public health, the FDA should not approve indacaterol at the proposed doses of 75 and 150 mcg.
Letter Urging Rejection of Florbetapir F18 Injection (Amyvid) (HRG Publication #1932)
The FDA, based on current evidence, should not approve florbetapir for the evaluation of patients suspected of having Alzheimer’s disease.
Letter on Liprotamase (Sollpura) (HRG Publication #1930)
These comments from Public Citizen Health Research Group are being submitted in follow-up to our testimony presented at the January 12, 2011 meeting of the Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee regarding the drug liprotamase (Sollpura).
Statement: FDA’s Response to Preventable Acetaminophen Toxicity Problem is Dangerously Inadequate (HRG Publication #1927)
The measures announced today by the Food and Drug Administration (FDA) concerning acetaminophen in prescription drug products are certainly a step forward, but they entirely fail to address the greater issue of over-the-counter (OTC) use of this drug and to implement strong recommendations made by three FDA advisory committees in June 2009 about this problem.
Testimony on Liprotamase (HRG Publication #1926)
Liprotamase, a new drug proposed to treat patients with cystic fibrosis who have problems digesting food should not be approved by the Food and Drug Administration (FDA), and further trials to determine the effectiveness of liprotamase would be unethical.
Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010 (HRG Publication #1924)
Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties.
Statement: FDA Must Not Approve Another Dangerous Weight Loss Drug (HRG Publication #1923)
The diet pill Contrave is the latest in a long line of dangerous and, ultimately, failed weight loss drugs
FDA’s Decision to Pull Diet Pill Meridia Commendable, But Took Too Long for Drug’s Victims (HRG Publication #1920)
The FDA’s decision to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks.
Study Reinforces Long-Known Dangers of Weight-Loss Drug Meridia (HRG Publication #1917A)
It is no surprise that a study published in the New England Journal of Medicine shows that the weight loss drug sibutramine (Meridia) increases the risk of strokes and heart attacks.
Testimony on Sibutramine (Meridia) Safety (HRG Publication #1918)
Sidney Wolfe, M.D. testified that the risks of sibutramine (Meridia) outweigh the benefits and that the drug should be removed from the market.
FDA’s Partial Hold on Unethical Diabetes Drug Trial Does Not Do Enough to Protect Patients (HRG Publication #1916)
The Food and Drug Administration (FDA) has gone only half-way in stopping the unethical TIDE study by halting the recruitment of any new patients. To allow the experiment to continue at all is a major breach in the FDA’s obligation to protect people in clinical trials.
Testimony on Rosiglitazone (Avandia) Safety (HRG Publication #1913)
Rosiglitazone (Avandia) compares unfavorably to Pioglitazone (Actos) and should be removed from the market.
Letter Urging FDA to Halt Rosiglitazone (Avandia) Trial (HRG Publication #1908)
We urge the FDA to halt an international diabetes trial that would put patients at unnecessary risk.
Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness (HRG Publication #1903)
In contrast to becoming more active and cautious in enhancing food safety by removing potentially dangerous products before they have caused harm, several FDA decisions in the past year regarding prescription drugs can only be described as reckless.
Petition to Ban Fibromyalgia Drug Milnacipran (Savella) (HRG Publication #1900)
Milnacipran (Savella) has highly questionable clinical efficacy and has been associated with a large number of potentially serious adverse reactions including hypertension, increased heart rate and an increased incidence of suicidal ideation.
Petition to Ban Sibutramine (Meridia) (HRG Publication #1898)
This purpose of this letter is to re-petition the FDA to immediately ban the weight loss drug, sibutramine (Meridia – Abbott – in the U.S.).
Petition Asking FDA to Reconsider Banning Propoxyphene (Darvon) (HRG Publication #1896)
This petition asks the FDA to reconsider granting our petition to ban Propoxyphene (Darvon)
Comments on FDA Draft Guidance on Postmarketing Studies and Clinical Trials (HRG Publication #1894)
Public Citizen has reviewed the draft guidance in detail and supports its purpose and approach.
Life-Threatening Liver Toxicity of Avandia Shown in New Public Citizen Research Published in Peer-Reviewed Medical Journal (HRG Publication #1886A)
WASHINGTON, D.C. - New research by Public Citizen published today in a peer-reviewed medical journal reinforces the case that the diabetes drug Avandia can cause death from liver failure and should be banned immediately by the Food and Drug Administration (FDA).
Public Citizen's Response to FDA Draft Guidance on Conduct of Clinical Trials in Community-Acquired Bacterial Pneumonia (HRG Publication #1886)
The Food and Drug Administration’s recent draft guidance on community-acquired bacterial pneumonia (CABP) is significant step forward from the previous draft guidance, issued in 1998. However, it includes recommendations that contradict established principles of rigorous clinical trial conduct, as defined in the International Conference on Harmonization documents E-9 and E-10, and a number of issues are left unaddressed.
Testimony of Peter Lurie, M.D., M.P.H and Hillary Peabody, M.P.H before the FDA Transparency Task Force (HRG Publication #1883)
Dr. Lurie and Hillary Peabody testify that pre-approval documents should be made available to the public, the FDA’s Freedom of Information Act (FOIA) processes should be made more efficient and consistent, and the FDA should expedite the production of standardized drug information for patients.
Testimony of James Floyd, M.D. at Meeting of Anti-Infective Drugs Advisory Committee onCethromycin for the Treatment of Community-Acquired Bacterial Pneumonia (HRG Publication #1875)
James Floyd, M.D. testifies about the design flaws in the studies conducted on cethromycin for the Treatment of community-acquired bacterial pneumonia.
Letter Urging the FDA to Halt its Review of Prasugrel (HRG Publication #1876)
Dr. Serebruany, Dr. Floyd and Dr. Wolfe encourage the FDA to stop its review of prasugrel until a new Phrase 3 study can be conducted with appropriate lower doses of prasugrel and properly defined outcomes.
Petition to the FDA Requesting Enhanced Warnings for Amitiza (lubiprostone) (HRG Publication #1871)
Public Citizen petitions the Food and Drug Administration (FDA) to add a black box warning regarding the risk of abortion to the Amitizia product label, change the drug's pregnancy category from C to X, contraindicate nursing while taking the drug, require the distribution of an FDA-approved Medication Guide for all patients, and mandate a “Dear Doctor” letter.
Letter to FDA About Safety Concerns with Prasugrel Hydrochloride and Removal of Dr. Sanjay Kaul from Cardiovascular and Renal Drugs Advisory Committee Meeting (HRG Publication #1857)
Public Citizen researchers present safety and efficacy data about prasugrel hydrochloride, and recommend labeling to effectively communicate the drug's risks (including hemorrhage and cancer) to consumers. The group also urges the removal of Dr. Sanjay Kaul from the Cardiovascular and Renal Drugs Advisory Committee meeting.
FDA Committee Vote Confirms Darvon’s Risks Outweigh Benefits, Drug Should Be Banned
Today’s Food and Drug Administration (FDA) advisory committee vote confirms that the risks of propoxyphene (Darvon) outweigh its benefits. The FDA must, therefore, remove it from the market.
Testimony of Sidney Wolfe Before Food and Drug Administration Advisory Committee on Propoxyphene (DARVON) (HRG Publication #1856)
Dr. Wolfe testifies before the Food and Drug Administration and advocates for a two-year phased withdrawal of these products.
Petition to Immediately Ban Diabetes Drug Rosiglitazone (AVANDIA) (HRG Publication #1848)
The Food and Drug Administration (FDA) should immediately ban the dangerous diabetes drug Avandia because it can cause death from liver failure and has many other life-threatening risks that far outweigh its benefits.
Op-Ed in Atlanta Journal-Constitution About Academic Conflict of Interest (HRG Publication #1846)
Peter Lurie and Jonas Hines criticize noted Emory University Psychiatry Chair Charles Nemeroff for not fully disclosing hundreds of thousands of dollars in consulting fees.
Testimony before FDA hearing on cough and cold remedies for children (HRG Publication #1845)
Public Citizen testified that the FDA was moving too slowly to get ineffective cough and cold remedies for children off the market. It also emphasized that there is no evidence for the medicines' effectiveness for children under 11 years.
Comments to the Accreditation Council on Continuing Medical Education (CME) advocating a ban on commercial support for CME (HRG Publication #1842)
Health Reasearch Groups's response to the ACCME's proposal to ban commercial support of Continuing Medical Education (CME).
Comments to FDA Re: Content and Format of Labeling for Human Prescription Drug and Biological Products: Requirements for Pregnancy and Lactation Labeling (HRG Publication #1841)
These comments on the FDA's proposed pregnancy and breastfeeding labels criticize the agency for an over-emphasis on often poor human studies and an under-emphasis on animal studies.
FDA Must Do More to Warn Patients Taking Flouroquinolone Antibiotics of Possible Tendon Ruptures
Statement of Sidney Wolfe, M.D., Director of the Health Research Group at Public Citizen
Petition to the FDA to Ban Ortho-Evra (HRG Publication #1840)
Ortho-Evra, the patch, estrogen, norelgestromin with ethinyl estradiol
Article in JAMA: Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death: A Meta-analysis (HRG Publication #1839)
A meta-analysis assesses the safety of blood substitutes and the risk of heart attack and death when these products are used.
Comments to FDA Re: Draft Guidance for Industry on Off Label Promotion of Drugs and Medical Devices (HRG Publication #1838)
Public Citizen submits comments on the Draft Guidance for industry that would regulate off label promotion of drugs and medical devices.
Letter criticizing an FDA proposed rule restricting the ability of drug companies to add safety warnings to their products' labels without prior FDA approval (HRG Publication #1836)
The agency has failed to demonstrate a need for revising this regulation. We urge the FDA to withdraw this ill-considered proposal.
Congress Must Act Quickly to Address Growing Crisis At the Food and Drug Administration
The Food and Drug Administration (FDA) is suffering from a crisis in leadership, a lack of congressional oversight and a dangerous reliance on the pharmaceutical industry to bankroll its operations, Sidney M. Wolfe, M.D., director of the Health Research Group at Public Citizen told a House of Representatives subcommittee this morning.
FDA Proposal on the Promotion of Off-Label Uses Highlights Drug Agency’s Recklessness
Statement of Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen
FDA's Botox Warning Falls Short
Statement of Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen
Stricter Warnings Needed for Botox, Myobloc Injections
The Food and Drug Administration (FDA) should immediately increase its warnings and directly warn patients and doctors about the use of botulinum toxin – available as Botox and Myobloc – because of serious adverse reactions, including deaths, linked to the drug, Public Citizen said in a petition filed Thursday with the agency.
FDA Neglecting Its Responsibility to Protect Children From Risky, Ineffective Cough and Cold Medicines
By simply warning parents not to administer over-the-counter cough and cold remedies to children under the age of 2, the U.S. Food and Drug Administration (FDA) has failed to properly address the glaring risks presented by this category of drugs, Public Citizen said today.
Drug Companies, FDA Lagged in Warning Public About Zetia, Vytorin
Statement by Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group
Antibiotic Leads to Tendon Ruptures; FDA Ignores Risks
Despite long-standing evidence that fluoroquinolone antibiotics can cause tendon ruptures, the Food and Drug Administration (FDA) has failed to increase its warnings to patients and physicians about the dangers of the medicines, Public Citizen told a federal court Thursday.
Comments on FDA's Draft Guidance for Industry - Drug-Induced Liver Injury: Premarketing Clinical Evaluation (HRG Publication #1833)
The FDA's guidance document confirms the agency's continued reluctance to seriously and publicly engage in post-mortem analyses of the growing number of mistakes the FDA has made concerning failed decision-making about either the approval of known hepatotoxic drugs or the dangerously delayed removal of ones showing hepatotoxicity shortly after approval.
FDA Should Deny Over-The-Counter Access to Risky Cholesterol Drug
Making the cholesterol medicine Mevacor available over the counter (OTC) could lead to widespread and possibly dangerous, inappropriate use of the drug, a fear backed up by the maker’s own data, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, told federal regulators Thursday.
Third Class of Drugs Is Bad Idea, Public Citizen Tells FDA (HRG Publication #1828)
Allowing patients to obtain certain drugs on the basis of counseling by a pharmacist but without a doctor’s prescription is a bad idea, Public Citizen told the Food and Drug Administration (FDA) today at a public hearing.
Children Under 12 Should Not Be Given Cough, Cold Medications, Public Citizen Tells FDA
Children under the age of 12 should not be given over-the-counter (OTC) cough and cold medicines, and remedies aimed specifically at children should be removed from the U.S. market, Public Citizen said today in testimony before the Food and Drug Administration (FDA).
Behind-the-Counter Drug Plan Needs More Time, Research and Input:Questions of Safety, Cost and Need Persist
Statement of Dr. Sidney Wolfe, Director of the Health Research Group at Public Citizen
Justice Department Dropped the Ball on OxyContin Probe, Public Citizen Tells Senators
The Justice Department’s criminal probe into the maker of OxyContin fell short in three key areas, allowing company officials to get off the hook for their misdeeds and failing to force the company to disgorge a much larger amount of its profits, Public Citizen told a Senate panel today.
Diabetes Drug Avandia Should Be Removed From the Market, Public Citizen Tells FDA Advisory Committee
The popular type 2 diabetes drug Avandia should be removed from the U.S. market, according to testimony delivered today by Public Citizen before a Food and Drug Administration (FDA) advisory committee panel investigating the medication.
Strong Federal Legislation Necessary to Require Clinical Trial Registries and Results Databases
Publicly available clinical trial registries and databases of the trials’ outcomes are necessary to counteract the tendency of pharmaceutical companies to suppress unfavorable study results, according to a report released today by Public Citizen.
European Drug Regulatory Authority Should Remove Arthritis Drug Etoricoxib and Weight Loss Drug Rimonabant From European Market
The European drug regulatory authority should immediately remove from the European market the arthritis drug etoricoxib (Arcoxia) and the anti-obesity drug rimonabant (Accomplia), according to a letter sent by Public Citizen to the European Medicines Agency (EMEA) today.
Federal Law Needed to Require Drug Companies to Disclose Payments to Doctors, Public Citizen Tells Congress
Current state laws that require the disclosure of pharmaceutical company payments to physicians are inadequate and a strong national disclosure law is needed, Public Citizen testified before Congress today.
FDA Rule Still Won’t Ensure That Dietary Supplements Are Safe or Effective
Statement by Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen
FDA Should Give Oral Presentations at All Advisory Committee Meetings, Public Citizen Tells Agency
Agency experts should be required to give presentations at all future Food and Drug Administration (FDA) advisory committee meetings discussing specific products, Public Citizen said in a petition filed today.
Testimony Before FDA Advisory Committee Meeting on Rimonabant (Zimulti) (HRG Publication #1815)
The Food and Drug Administration (FDA) should not approve the new diet drug rimonabant (marketed as Acomplia in Europe and known as Zimulti in the U.S.) because it produces only modest weight loss and has been shown to produce serious physical and psychological adverse effects, according to Public Citizen testimony before an FDA advisory committee meeting today.
Letter About Ethical Concerns with Hepatitis E Vaccine Trial in the New England Journal of Medicine (HRG Publication #1814)
Peter Lurie and Sanjay Basu criticize the hepatitis E virus (HEV) vaccine trial on ethical grounds, arguing that any viable vaccine be made available to those who were part of the studies.
FDA Knew of Avandia’s Dangers Nearly Five Years Ago, Memo Shows
The Food and Drug Administration (FDA) knew nearly five years ago about the dangers associated with the diabetes drug Avandia, an internal FDA memo shows.
Testimony on Programs Affecting Safety and Innovation in Pediatric Therapies (HRG Publication #1811)
Many drugs and medical devices are not adequately tested in children, in part because Congress does not give the FDA enough power to require pediatric studies.
Evidence Confirms Public Citizen’s Warnings About the Risks of Popular Diabetes Drug Avandia
Statement by Sidney Wolfe, MD, Director of Health Research Group at Public Citizen
Penalties for Misbranding OxyContin Are Too Little
Statement of Sidney M. Wolfe, MD, Director, Health Research Group of Public Citizen
Eliminate FDA’s Dependency on Drug Industry Money, Public Citizen Tells Congress
Congress should not reauthorize the user fees at the core of the Prescription Drug User Fee Act (PDUFA) because of the unacceptable conflicts of interest the fees create at the Food and Drug Administration (FDA), Public Citizen said today in a letter sent to all members of Congress.
Comments on a Draft of the Safe Drug Compounding Act of 2007 (HRG Publication #1809)
Legislation should clearly define legitimate traditional pharmacy compounding while protecting the public from unsafe compounding practices.
Comments on FDA Obesity Trial Guidelines (HRG Publication #1808)
We hope that the revised FDA guidelines on clinical trials for obesity drugs will include a requirement that will finally provide information on the long-term effects of these drugs on morbidity and mortality.
Testimony before the FDA Arthritis Advisory Committee concerning Arcoxia (HRG Publication #1806)
In addition to strongly urging your committee and the FDA to reject Merck’s effort to approve etoricoxib in the U.S, I urge prompt removal of Arcoxia from the market in the 60+ countries where it is causing unacceptable risks to the hundreds of thousands of people using the drug.
FDA Should Not Approve Painkiller Dubbed “Offspring of Vioxx”
Public Citizen today urged the government to reject an application for a new painkiller – Arcoxia – that is in the same class of drugs as Vioxx and, like that drug, is associated with an increased risk of cardiovascular problems.
Letter to the FDA concerning Pfizer's 2 ½ minute television advertisement for Celebrex (HRG Publication #1803)
We urge the Food and Drug Administration to order Pfizer to immediately stop its dangerous, misleading 2 ½ minute television advertisement for Celebrex that began airing on April 2nd.
Description of efforts to redesign surfactant (SURFAXIN) study in Latin America (HRG Publication #1802)
An unethical placebo-controlled drug trial in Latin America was redesigned following a campaign by Public Citizen. In 2001, Discovery Laboratories Inc. of Doylestown, Penn. redesigned its study of Surfaxin, its brand of surfactant, after effective pressure from Public Citizen.
FDA Should Not Have Approved Tegaserod (Zelnorm); Public Citizen Warned of Dangers When Drug Was Considered in 2001
Statement of Sidney Wolfe, MD, director of Public Citizen’s Health Research Group
Drug Company Payments to Doctors Often Exceed Recommended Limits; Data Widely Unavailable to the Public
Payments from pharmaceutical companies to physicians are not readily accessible to the public despite new state disclosure laws and often involve substantial sums, according to an article co-authored by Public Citizen published today in the Journal of the American Medical Association (JAMA).
Comments to the FDA: Access to and Cost of Investigational Drugs (HRG Publication #1800)
Comments on FDA Dockets: Expanded Access to Investigational Drugs for Treatment Use (Docket No. 2006N-0062) and Charging for Investigational Drugs (Docket No. 2006N-0061)
FDA Approval of Over-the-Counter Orlistat Is Reckless
Statement of Dr. Sidney M. Wolfe, Director of Public Citizen’s Health Research Group
Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel due to Increased Risk of Venous Thrombosis (HRG Publication #1799)
It is estimated that women in the U.S. filled more than 7.5 million prescriptions for third generation oral contraceptives this past year (November 2005 to October 2006) (IMS, National Prescription Audit). By banning third generation oral contraceptives, the FDA will potentially save hundreds of young women a year from developing venous thrombosis and its disabling and sometimes fatal consequences.
Letter in the Lancet: Suboptimum use of FDA drug advisory committees (HRG Publication #1796)
A declining minority of products faces advisory committees, the FDA frequently elects not to present its own interpretations of the sponsor’s data, and the rate of inconsistency between advisory committee recommendations and subsequent FDA actions is higher than is generally assumed.
FDA Proposal for Painkiller Warning Is Decades Late
Statement of Dr. Peter Lurie, Deputy Director of Public Citizen’s Health Research Group
Trials of Prophylaxis to Prevent Recurrent Herpes Should not Utilize a Placebo Arm (HRG Publication #1794)
Researchers of this study placed their patients at higher risk unnecessarily in a study where valacyclovir was administered to pregnant women with a history of genital herpes simplex virus (HSV).
Article in Law and Contemporary Problems: Access to Pharmaceutical Data at the FDA (HRG Publication #1789)
Advocates of greater corporate involvement in clinical science argue that the public benefits from the more rapid movement of beneficial products into commerce, but progress in science is based on the free publication of study results and on the public release of data. In contrast, the governing ethic in the corporate sector is secrecy -- the withholding of any information from which a competitor might benefit.
Public Citizen Petitions the FDA to Include a Black Box Warning on Fluoroquinolone Antibiotics (HRG Publication #1781)
Public Citizen, representing more than 100,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA), pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States.
The US FDA at a Crossroads (HRG Publication #1780)
Peter Lurie suggests four reforms for the Food and Drug Administration as the agency enters its second 100 years.
Letter to FDA Commissioner Requesting Enforcement Against Maker of Nicotine Beverages (HRG Publication #1777)
Public Citizen and the Campaign for Tobacco-Free Kids requests that the FDA enforces regulations that would ban nicotine beverages.
The 100th Anniversary of the FDA: The Sleeping Watchdog Whose Master is Increasingly the Regulated Industries (HRG Publication #1776)
As we celebrate the 100th anniversary of this important agency, there are too many instances in which it appears to be moving back into 19th century when industry did what it wanted rather than into the 21st century.
Update on Use of Growth Hormone for Normal Small Children: Discussed on CNN International June 20, 2006 (HRG Publication #1774)
Since HRG testified against the approval of growth hormone for small normal children at an FDA hearing three years ago, additional information confirming the concerns we expressed is now available.
Supplement to petition to ban diet drug orlistat (XENICAL). Additional information provided about pre-cancerous changes to the colon (HRG Publication #1771)
There is more than enough evidence to take orlistat off the market as a prescription drug and thereby end the process of switching it to over-the-counter status.
Testimony before FDA Advisory Committee on Rivastigmine (Exelon) for Dementia Associated with Parkinson’s Disease (HRG Publication #1769)
Testimony of Peter Lurie, MD, MPH and Elizabeth Barbehenn, PhD Before FDA Peripheral and Central Nervous System Drugs Advisory Committee Meeting on Rivastigmine (Exelon) for Dementia Associated with Parkinson’s Disease
Petition to the FDA to Immediately Ban the Antibiotic Gatifloxacin (Tequin) (HRG Publication #1768)
Petition by Joseph Baker, M.D., M.P.H., Sidney Wolfe, M.D. and Peter Lurie, M.D., M.P.H.
Comments to the New Zealand Ministry of Health on Direct-to-Consumer Advertising of Prescription Drugs (HRG Publication #1767)
Comments to the New Zealand Ministry of Health on Direct-to-Consumer Advertising of Prescription Drugs
Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings (HRG Publication #1765)
Disclosures of conflicts of interest at drug advisory committee meetings are common, often of considerable monetary value, and rarely result in recusal of advisory committee members. A weak relationship between certain types of conflicts and voting behaviors was detected, but excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.
Petition to the FDA to immediately remove the diet drug orlistat (XENICAL) from the market (HRG Publication #1764)
This drug, which treats obesity, causes a significant increase in the incidence of aberrant crypt foci, which are widely believed to be a precursor of colon cancer.
Petition to FDA to ban all propoxyphene (DARVON) products; prescription painkiller causes many fatalities (HRG Publication #1762)
Petition by Sidney M. Wolfe, M.D., Dan Suzman, Ulf Jonasson, Dr.PH and Birgitta Jonasson, Ph.D.
Testimony Before the FDA Advisory Committees on Possible Switch of Orlistat (XENICAL) to OTC Status (HRG Publication #1760)
Before the FDA Non-Prescription and Endocrine and Metabolic Drug Advisory Committees Hearing on Possible Switch of Orlistat (XENICAL)to OTC Status (HRG Publication #1760)
Statement Before the Institute of Medicine Committee Assessing the U.S. Drug Safety System (HRG Publication #1759)
Testimony on the adequacy and conclusions of FDA’s pre-approval review and ongoing post-approval reviews.
Widespread Drug Marketing Violations Occurred at American Psychiatric Association Convention (HRG Publication #1779)
More than half the drug makers that participated in the 2002 American Psychiatric Association (APA) convention violated drug marketing rules set up by the association or the Food and Drug Administration (FDA), Public Citizen writes in a study in the current issue of The Journal of Public Health Policy.
Statement by Sidney Wolfe, MD, at the Public Hearing on CDER's Current Risk Communication Strategies for Human Drugs (HRG Publication 1758)
Statement by Sidney Wolfe, MD, at the Public Hearing on CDER's Current Risk Communication Strategies for Human Drugs (HRG Publication 1758)
Letter to FDA urging that the diabetes drug muraglitazar (PARGLUVA) not be approved because of an increased risk of serious adverse reactions including death (HRG Publication #1756)
Public Citizen urged the FDA to not approve the drug until, at the very least, a five-year randomized controlled trial is completed to more thoroughly assess the drug’s risks.
Letter to FDA urging the immediate recall of all outstanding supplies of generic pemoline from the market (HRG Publication #1754)
It is reckless and insensitive to the health and lives of children and adults using this drug for the FDA and the involved drug companies to fail to institute an immediate recall of these dangerous products. Otherwise, when the next case of liver damage, fatal or otherwise, occurs, the parents and other relatives of the drug's victim will ask the government and the companies, "Why did you allow this to happen?"
Petition to the FDA to require a black box warning for erectile dysfunction drugs (Viagra, Cialis, Levitra) to warn of the potential for irreversible vision loss (HRG Publication #1753)
Viagra accounts for more cases of a type of vision loss called ischemic optic neuropathy (ION) than any other drug (19 percent) and more than double the percentage of the next most often-reported drug.
Misleading data analyses in salmeterol (SEREVENT) study (HRG Publication #1752)
These documents provide insight into the manner in which the company manipulated the data it submitted to the FDA in an apparent attempt to convince the agency that the drug's risks were smaller.
Testimony before the Senate Special Committee on Aging on The Impact of Direct-to-Consumer Drug Advertising on Seniors’ Health and Health Care Costs (HRG Publication #1751)
DTC advertising is nothing less than an end-run around the doctor-patient relationship – an attempt to turn patients into the agents of pharmaceutical companies as they pressure physicians for medications they may not need.
Testimony before FDA Advisory Committee on new diabetes drug Muraglitazar (PARGLUVA): Risks outweigh the benefits. (HRG Publication #1749)
Muraglitazar is a drug with modest ability to reduce hemoglobin A1C, but no proven ability to reduce the micro- and macrovascular complications that are the real concern in diabetes management.
FDA Denial of Public Citizen’s Petition to Ban Meridia Is Misguided (HRG Publication #1748)
How many more dangerously flawed decisions will the FDA make before the Congress repeals the Prescription Drug User Fee Act, which brings the agency ever closer to – and makes the agency less vigilant over – the companies that give it almost $200 million a year in funding?
Letter to FDA concerning FDA-approved Medication Guides (HRG Publication #1746)
Letter to FDA concerning FDA-approved Medication Guides (HRG Publication #1746)
Testimony before FDA Public Meeting on Levothyroxine Sodium Therapeutic Equivalence (HRG Publication #1744)
This hearing is simply the latest round in a decades-long debate in which discredited scientific arguments are repeated and uncorroborated clinical anecdotes recycled in an effort to generate enough confusion to maintain the market share of the brand name medication, Synthroid, and, to a lesser extent, Levoxyl.
Drugs and breastfeeding--a letter to the Editor of Australian Prescriber (HRG Publication #1740)
Drugs and breastfeeding--a letter to the Editor of Australian Prescriber
Supplement to Petition to the FDA to Withdraw the Lung Cancer Drug gefitinib (Iressa) from the Market (HRG Publication #1739)
Supplement to Petition to the FDA to withdraw the lung cancer drug gefitinib (Iressa) (HRG Publication #1739)
Comments submitted on FDA Guidance for Industry on Clinical Lactation Studies (HRG Publication #1735)
Comments by Elizabeth Barbehenn submitted to FDA Guidance for Industry on Clinical Lactation Studies (HRG Publication #1735)
Bextra Ban a Good Step, But FDA Should Pull Celebrex Too (HRG Publication #1734)
Statement of Sidney M. Wolfe, M.D., Director, Public Citizen's Health Research Group
Statin-associated rhabdomyolysis (HRG Publication #1733)
Letter to the editor that appeared in the April 2005 issue of Pharmacoepidemiology and Drug Safety. Submitted by Amer Ardati MD, Paul Stolley MD, Deanne E. Knapp PhD, Sidney M. Wolfe MD and Peter Lurie MD, MPH*
US exceptionalism comes to research ethics - Comment by Peter Lurie in The Lancet (HRG Publication #1732)
Critical commentary on the US administration's attempts to ignore key ethical issues in medical research as outlined by the 2000 Declaration of Helsinki.
Petition to the FDA to remove the Attention Deficit drug pemoline (CYLERT) from the market because of liver toxicity (HRG Publication #1731)
Petition to the FDA to remove the Attention Deficit drug pemoline (CYLERT) from the market because of liver toxicity (HRG Publication #1731)
Letter to FDA shows that Crestor has higher rates of rhabdomyolysis compared to other statins (HRG Publication #1729)
Crestor (rosuvastatin) has 2.8 times the rate of rhabdomyolysis of the second most toxic statin, analysis shows
Painkillers and Terrorism. Letter to the Editor of the New York Times on Cox 2 Painkillers (HRG Publication #1727)
Painkillers and Terrorism. Letter to the Editor of the New York Times on Cox 2 Painkillers (HRG Publication #1727)
Letter detailing needed improvements to FDA's essential MedWatch Adverse Events Reporting System (HRG Publication #1726)
Letter detailing needed improvements to FDA's essential MedWatch Adverse Events Reporting System (HRG Publication #1726)
Testimony to FDA on Dangers of Cox-2 Drugs (HRG Publication #1725)
Testimony of Sidney M. Wolfe, M.D. Director, Public Citizen’s Health Research Group (HRG) Before FDA Arthritis and Drug Safety Advisory Committees Concerning the Dangers of COX-2 Drugs
Congressional Testimony by Sidney Wolfe M.D. on Current Issues Related to Medical Liability Reform (HRG Publication #1724)
Congressional Testimony on Current Issues Related to Medical Liability Reform (HRG Publication #1724)
Letter to FDA revealing heart dangers in an unpublished clinical trial of Celebrex (HRG Publication #1721)
Trial revealing statistically significant heart dangers for Celebrex discovered on PhRMA website
Petition to remove the Cox-2 Inhibitors Celecoxcib (CELEBREX) and Valdecoxcib (BEXTRA) From the Market (HRG Publication #1720)
Petition to remove the Cox-2 Inhibitors Celecoxcib (CELEBREX) and Valdecoxcib (BEXTRA) From the Market (HRG Publication #1720)
The Serious Public Health Dangers of Prescription-to-OTC Switch of Lovastatin: Testimony by Sidney M. Wolfe, MD Before the FDA Endocrinologic/Metabolic and Non-Prescription Drugs Advisory Committees (HRG Publication #1719)
The potential benefits of an OTC switch for the statin drug Mevacor (lovastatin) do not outweight the substantial risks: The Serious Public Health Dangers of Prescription-to-OTC Switch of Lovastatin--Testimony Before FDA Endocrinologic/Metabolic and Non-Prescription Drugs Advisory Committees
Take drugs off the market - Editorial in USA Today, December 27th, 2004 (HRG Publication #1715)
Take drugs off the market -Editorial in USA Today, December 27th, 2004 (HRG Publication #1715)
Response to FDA's Announcement about Use of Celebrex and Bextra (HRG Publication #1714)
Statement Concerning FDA's Announcement about Use of Celebrex and Bextra (HRG Publication #1714)
Testimony Before the FDA Reproductive Health Advisory Committee Concerning the Transdermal Testosterone Patch (HRG Publication #1713)
Testimony Before the FDA Reproductive Health Advisory Committee Concerning the Transdermal Testosterone Patch (HRG Publication #1713)
Letter to FDA urging action on misleading CRESTOR advertising by AstraZeneca (HRG Publication #1712)
Letter to FDA urging action on misleading CRESTOR advertising by AstraZeneca (HRG Publication #1712)
Letter to FDA Renewing Call for Crestor to Be Removed From Market. Rate of Kidney Damage in Crestor Patients Is 75 Times Higher Than in Patients Taking Other Cholesterol Drugs (HRG Publication #1710)
Letter to FDA Renewing Call for Crestor to Be Removed From Market. Rate of Kidney Damage in Crestor Patients Is 75 Times Higher Than in Patients Taking Other Cholesterol Drugs (HRG Publication #1710)
Dangers of rosuvastatin identified before and after FDA approval (HRG publication #1699)
The lipid-lowering drug rosuvastatin is currently in the midst of the most heavily financed launch of a prescription drug ever. Here I present premarketing and postmarketing evidence of the dangers of the drug, and call for its removal from the market. Detailed briefing documents including unpublished reviews of safety and efficacy data from clinical trials are now made public on the internet before all Food and Drug Administration (FDA) advisory committee meetings discussing the approval of a new drug.
Vioxx, Other “Super Aspirins” Are Super Disasters – Other Cox-2 Alternatives Have Safety Problems Too (HRG Publication #1707)
Today’s announcement by Merck is the latest evidence that this family of drugs, the Cox-2 inhibitors, once referred to as “super aspirins,” are turning out to be more like super disasters.
Testimony before the FDA's Cardiovascular and Renal Drugs Advisory Committee Hearing on Ximelagatran--September 10, 2004 (HRG Publication #1706)
Testimony of Peter Lurie, MD, MPH, and Elizabeth Barbehenn, PhD of Public Citizen's Health Research Group, before the FDA's Cardiovascular and Renal Drugs Advisory Committee Hearing on Ximelagatran
Letter to the FDA's Office for Science and Health Coordination urging them not to abandon the Declaration of Helsinki in ensuring protection of human subjects in certain foreign clinical studies (HRG Publication #1705)
Letter to the FDA's Office for Science and Health Coordination Regarding the Protection of Human Subjects in Foreign Clinical Studies not Conducted Under an Investigational New Drug Application (HRG Publication #1705)
Letter to FDA calling for criminal investigation of AstraZeneca because the company illegally delayed submitting reports of serious adverse reactions to cholesterol drug Crestor. (HRG Publication #1703)
Public Citizen Calls for Criminal Investigation of AstraZeneca. Company Illegally Delayed Submitting Reports of Serious Adverse Reactions to Cholesterol Drug Crestor.
Drug ads masquerading as news: letter to 258 local television station general managers and news directors in the country's top-30 television markets (HRG Publication #1702)
This summer, health information publisher MediZine Inc. and syndicated news programmer Daily Health Feed (DHF) will begin offering a series of health-related features to TV stations in major U.S. markets. This will be in addition to the DHF health news feeds that already are carried by stations in 39 markets. According to MediaDailyNews, these segments will be bought and paid for by major pharmaceutical marketers and offered free of charge to local stations.
Letter to NIH Director questioning the propriety of the actions of a senior NIH scientist who was a consultant for AstraZeneca. (HRG Publication #1700)
Letter to NIH Director questioning the propriety of the actions of a senior NIH scientist who was a consultant for AstraZeneca. was the editor of the proceedings of a symposium and the author of an article in the proceedings containing an incomplete, inaccurate analysis understating the serious risks of AstraZeneca’s cholesterol-lowering drug, rosuvastatin (Crestor).
Letter to the FDA urging removal of the cholesterol-lowering drug rosuvastatin (CRESTOR) from the market (HRG Publication #1698)
As you are aware, on March 4th of this year, we petitioned the FDA to ban the recently-marketed cholesterol-lowering drug rosuvastatin (Crestor/AstraZeneca) because of seven post-marketing cases of life-threatening rhabdomyolysis and nine cases of renal failure or renal insufficiency,
Petition to the FDA to remove the cholesterol-lowering drug rosuvastatin (CRESTOR) from the market (HRG Publication #1693)
We have obtained new information from the FDA and health agencies in Canada and the U.K. concerning serious post-marketing adverse reactions – including seven cases of life-threatening rhabdomyolysis (muscle destruction) and nine cases of kidney failure or kidney damage – in patients mostly using lower doses of this recently-approved cholesterol-lowering drug, rosuvastatin.
Letter to World Medical Association concerning continuing efforts to amend Declaration of Helsinki (HRG Publication #1692)
The 2000 Declaration of Helsinki offered, for the first time, in language that was as clear as was possible, an enunciation of what ought to have been standard practice for decades. There is no justification for retreating from that important step forward. It is time to get past the delay-of-game tactics of Paragraph 30’s opponents and beginning to ensure that the fundamental ethical principles it enshrines are actually enforced.
Testimony before FDA Advisory Committee on Accutane. It should be removed from the market and prescribed only under very limited and controlled conditions. (HRG Publication #1691)
The acne drug Accutane, which causes birth defects and life-threatening adverse events, should be removed from the market and prescribed only under very limited and controlled conditions. Testimony before FDA Advisory Committee (HRG Publication #1691)
Petition to the FDA to Keep Silicone Gel Breast Implants Off the Market (HRG Publication #1682)
The National Organization for Women, Public Citizen’s Health Research Group, and the National Women’s Health Network petitioned the FDA to stay its review of and decision on any and all Premarket Applications (PMAs) for silicone gel-filled breast implants until an amendment to such PMAs is submitted to the FDA responding to the deficiencies identified in this petition and consisting of adequate data demonstrating a reasonable assurance of safety or effectiveness of such implants.
Supplement to Petition to the FDA to ban the anitidepressant drug nefazadone (SERZONE) (HRG Publication #1681)
We have now updated that analysis to cover the subsequent time period, April 1, 2002 through May 12, 2003. During that period, FDA adverse event data recorded an additional 9 deaths, for a total of 20 reports of death due to liver failure in people using Serzone.
Letter to FDA concerning potentially dangerous patient information on Hormone Replacement Therapy (HRG Publication #1677)
Rather than promoting incomplete information, you should seek to ensure that women ask for and receive the FDA-approved patient information that is required by regulation to be distributed with each prescription for a non-contraceptive estrogen product.
Food and Drug Disaster. OpEd appearing in Washington Post on September 10, 2003 (HRG Publication #1676)
With gusto, Food and Drug Administration Commissioner Mark McClellan has promoted, in speeches and press releases, one of his priorities: increasing the amount of accurate information conveyed to consumers about FDA-regulated products. Unfortunately, this rhetoric obscures a pattern of FDA actions and inaction under his leadership that decrease the amount of accurate information in the marketplace.
Petition supplement to FDA outlining the rising number of cardiovascular events associated with the diet drug sibutramine (MERIDIA) (HRG Publication #1675)
Since then [since the original petition] , from reviewing subsequent FDA adverse event data, we have become aware of an additional 30 cardiovascular deaths in people using Meridia, for a total of 49 cardiovascular deaths. Twenty-seven of the 49 (68%) were in people less than 50 years old.
Letter to the World Medical Association opposing proposed changes to Paragraph 30 of the Declaration of Helsinki (HRG Publication #1674)
For if researchers can, with limited effort, escape the requirement to provide drugs to their own participants/patients at the conclusion of a trial, how can they be required to provide medications to those who have never been under their care?
Comments by Sidney M. Wolfe, M.D and Larry D. Sasich, Pharm.D., M.P.H. before FDA Hearing on Current Status of Useful Written Prescription Drug Information for Consumers, July 31, 2003 [Docket No. 03N-0168] (HRG Publication #1672)
It is time to end the double standard wherein doctors and other health professionals use and are informed by FDA-approved labeling but patients, like second-class citizens, get whatever the out-of-control purveyors of patient information leaflets choose to have dispensed to them with their prescription drugs.
Statement of Sidney M. Wolfe, MD before the FDA Endocrinologic and Metabolic Drugs Advisory Committee Hearing on Rosuvastatin (HRG Publication #1669)
In summary, we strongly oppose the approval of rosuvastatin because of its unique renal toxicity. We are also seriously concerned because of the seven cases of rhabodmyolysis that were common enough to have shown up in clinical trials, unlike the pre-approval studies with all previously approved statins, including cerivastatin.
Statement of Peter Lurie, MD, MPH before National Academy of Sciences' Committee on Clinical Research Involving Children (HRG Publication #1668)
A strong statement by the Committee condemning the export of pediatric studies for the purposes of exploiting the lack of ethical oversight or the poverty of pediatric patients in developing countries would be most helpful.
Testimony of Sidney Wolfe, M.D. before Endocrinologic and Metabolic Drugs Advisory Committee concerning the use of growth hormone for idiopathic short stature (HRG Publication 1667a)
Testimony of Sidney Wolfe, M.D. before Endocrinologic and Metabolic Drugs Advisory Committee concerning the use of growth hormone for idiopathic short stature
Petition to the FDA to add a black box warning to the label of the cancer drug IRESSA (HRG Publication #1667)
Petition to the FDA to add a black box warning to the label of the cancer drug IRESSA (HRG Publication #1667)
Letter to FDA expressing concerns about the pending approval of the cancer drug gefitinib (IRESSA) (HRG Publication #1665)
We understand that the gravity of NSCLC and the lack of effective therapy leave patients with few treatment options. But in this case, the data are either the product of poorly designed trials or, in the better-designed trials, unequivocally negative. Approval of any drug under these circumstances cannot be justified.
Article by Sidney Wolfe in Science magazine: Ephedra Scientific Evidence Versus Money/Politics (HRG Publication #1664)
Twenty-Year Chronology of Events Concerning Ephedrine Alkaloids, released in conjunction with publication of article in Science magazine: Ephedra Scientific Evidence Versus Money/Politics
Letter to NIH Director that continues to raise ethical concerns about the “Alzheimer’s Disease Anti-Inflammatory Prevention Trial” (ADAPT) (HRG Publication #1663)
Letter to NIH Director that responds to their reply to 9/03/02 letter that raises ethical concerns about the Alzheimer’s Disease Anti-Inflammatory Prevention Trial.
Statement of Paul D. Stolley, MD, MPH that comments on the FDA Risk-Management Concept Papers (HRG Publication #1656)
We are also concerned that the promise of postmarketing studies may be used to approve new drugs inappropriately or delay the removal or relabeling of dangerous drugs. In a survey of the FDA’s reviewing Medical Officers that the Health Research Group conducted in 1998, many officers felt pressure to approve drugs that they might not have approved; the companies’ promises of Phase 4 studies (many of which will presumably never be completed) tipped the balance for approval.
Petition to the FDA to Ban the Antidepressant Drug Nefazadone (SERZONE) (HRG Publication #1657)
Our own analysis, based on adverse reaction reports to the FDA, revealed that, from 1994, when first marketed, through the first quarter of 2002, nefazodone was associated with at least 53 cases of liver injury including 21 cases of liver failure from which 11 people died.
Remedies Needed to Address the Pathology in Reporting Adverse Reactions and Food and Drug Administration Use of Reports (HRG Publication #1659)
The articles in this issue concerning adverse events and errors provide an overview of the anatomy and physiology of the process of soliciting and analyzing adverse drug reaction reports at the Food and Drug Administartion (FDA) and a useful taxonomy of the ways of measuring errors and adverse events more generally in health care. Both fall short, however, of addressing the most serious pathology and proposing adequate remedies.
Comments to FDA on First Amendment Issues, specifically related to FDA enforcement of drug advertising laws and regulations (HRG Publication #1645)
We begin with a brief discussion of the nature of advertising and FDA enforcement actions with regard to advertising. We then address promotion of products for unapproved uses, including promotion of products never approved for any use.
Letter to FDA addressing Dr. Gary Firestein's comments concerning HRG's petition to remove ARAVA from the market (HRG Publication #1644)
It is discouraging that we have a so-called expert in the field of rheumatology who, apparently, has not thoroughly read either our petition or the original label for leflunomide, yet feels free to attack our petition. We tried in our petition to present as much information as was available, to analyze it rigorously, and to provide references so that our statements could be checked; unfortunately, Dr. Firestein failed to do this.
Testimony Before Senate Governmental Affairs Committee Hearing on Dangers of Ephedra (HRG Publication #1642)
This apparently inherent ability of ephedrine alkaloids to provoke chest pain and induce myocardial infarction in healthy patients is of particular concern because of the implications for vulnerable patients using other medications or with previously undiagnosed underlying medical conditions. Note that some of these adverse cardiovascular events can occur at the recommended dose.
An Outbreak of Web Sites Selling Ciprofloxacin Following an Outbreak of Anthrax by Mail (HRG Publication #1641)
We identified 59 Web sites selling ciprofloxacin without prescription, 23 (39%) of which were established during the 2 weeks following October 4, 2001 (Figure 1). None of the sites was certified by the Verified Internet Pharmacy Practice Sites program.
Statement on Safety Issues Related to Acetaminophen Before the Nonprescription Drugs Advisory Committee (HRG Publication #1639)
A quarter of a century later we are facing an epidemic of fatal acetaminophen-associated poisonings: a near doubling from 76 in 1995 to 141 in 1999, according to data collected by the American Association of Poison Control Centers through its Toxic Exposure Surveillance System (TESS).
Response to FDA Request for Comments on First Amendment Issues (HRG Publication #1638)
The extent to which the pharmaceutical industry controls the flow of information about its products is chilling, including the opportunity to manipulate the peer reviewed medical literature. The notion that market forces or physician expertise can adequately protect the public from being prescribed drugs for uses for which they have not been shown to be safe and effective flies in the face of the facts.
Letter to HHS Secretary Tommy Thompson that raises ethical concerns about the “Alzheimer’s Disease Anti-Inflammatory Prevention Trial” (ADAPT) (HRG Publication #1637)
Because patients are taking drugs without true informed consent, Public Citizen urges the NIA to immediately stop this unethical trial and provide patients already enrolled in the trial with the information previously denied them on lack of plausible benefit as well as the possible health risks.
Letter to the Accreditation Council for Graduate Medical Education (ACGME) regarding its draft "Principles to Guide the Relationship between Graduate Medical Education and Industry" (HRG Publication #1636)
Cop out. There is no other way to describe the ACGME draft Principles to Guide the Relationship between Graduate Medical Education and Industry. The draft Principles are an at-times eloquent description of the massive conflicts that attend the growing relationship between industry and medical education programs. But when it comes time for the draft Principles to actually delineate what is and is not acceptable, the raison d'etre for these Principles, the draft document simply evades the issue.
Letter to HHS Secretary Tommy Thompson urging him to direct the FDA to open a criminal investigation of Metabolife (HRG Publication #1635)
This letter strongly urges you to direct FDA Chief Counsel Dan Troy to agree that a criminal investigation of Metabolife be opened, as requested in a July 1, 2002, letter he was sent from Eugene M. Thirolf, Director, Office of Consumer Litigation, U.S. Department of Justice (DOJ). In that letter, the DOJ official states that Michael Ellis, the President of Metabolife, one of the nation’s largest producers of ephedrine-based dietary supplements, may have made false statements to the FDA.
Letter to the Editor of the Washington Post on "Botox Night" at Johns Hopkins Hospital (HRG Publication #1634)
Patrick J. Byrne revises history in his Aug. 3 letter about the July 11 Botox Night at Johns Hopkins when he claims that the organization of the seminar was never altered.
Letter to the Editor of the British Medical Journal on previous article on Disease Mongering (HRG Publication #1631)
Like the groups described by Moynihan et al, the 3M/ National Vaginitis Association is ostensibly an educational resource run by health professionals.Unfortunately, its activities include a large element of disease mongering. Mild symptoms are offered as portents of serious disease, and doctors are encouraged to be aggressive in their attempts to diagnose and treat vaginal infections, specifically bacterial vaginosis.
Comments before FDA Drug Safety Advisory Committee on Patient Drug Information (HRG Publication #1629)
The failure of the private sector to meet the quality goals established in The Action Plan and thus the failure to achieve the distribution goal of 75 percent of patients getting scientifically accurate information leaves only one option under Public Law 104-180: the Secretary [Department of Health and Human Services] shall seek public comment on other initiatives that may be carried out to meet such goals.
Letter to the President of the Association of American Medical Colleges urging a national policy precluding the demonstration or administration of medical interventions such as Botox (HRG Publication #1628)
To our knowledge, Johns Hopkins is the first medical school to have planned such an event. Given the increasing commercialization of medicine, including the proliferation of Botox parties, and its corrosive impact upon the credibility of the profession and the nation s medical schools, the time seems ripe to develop a national policy for medical schools that would preclude the demonstration or administration of medical interventions such as Botox.
Letter to Dean of the Medical Faculty at Johns Hopkins School of Medicine urging the cancellation of "Botox Night" (HRG Publication #1627)
If you wish to ensure that the Johns Hopkins School of Medicine maintains its reputation as one of the world’s leading medical schools, you will immediately cancel the Botox Night, similar in many respects to a so-called Botox Party, scheduled for Johns Hopkins’ Outpatient Center this Thursday, July 11. This event is unseemly, unprofessional and undermines the core educational mission of the university.
Statement on HHS Failure to Ban Ephedra or Issue Adequate Warnings (HRG Publication #1624)
Today’s announcement by the Department of Health and Human Services (HHS), which not only fails to ban ephedra dietary supplements but also fails to seriously warn against the use of these products, should result in the firing of all officials in HHS and the Food and Drug Administration (FDA) who are responsible for this dangerous cowardice.
Comments on Food and Drug Administration (FDA) Information Quality (HRG Publication #1623)
In fact, the initiative seems less motivated by an affinity to improved scientific standards than it is by industry’s desire to reduce the amount of potentially lifesaving information disseminated, needlessly delay information that actually makes it through the gauntlet represented by these standards and potentially provide industry with a mechanism to force agencies to withdraw documents previously issued by the FDA that the industry finds troublesome.
Allowing Lotronex Back on the Market Will Endanger Patients (HRG Publication #1622)
Reintroducing Lotronex onto the market as announced today by the U.S. Food and Drug Administration (FDA) will endanger patients, Public Citizen said today. Not only is the new marketing program too lax to prevent harm, but it is to be overseen by the company that makes the drug – a poor idea because the company has a financial incentive to downplay problems with the drug. Also, the recommended dose has not been shown to be effective.
Statement at FDA Hearing on Risk Management of Prescription Drugs (HRG Publication #1620)
The single most important risk management strategy the FDA can undertake in the short-term to reduce the publics risk from preventable adverse drug reactions is to go forward as rapidly as possible with regulations that require pharmacists to distribute scientifically accurate, useful written drug information, or Medication Guides, approved by the agency. At the very least, this would provide consumers with a reliable source of information that they can use to protect themselves from preventable injury.
Letter to HHS urging that criminal charges be brought against Abbott Laboratories for illegally withholding information concerning eight deaths and other adverse effects of the drug sibutramine (MERIDIA) (HRG Publication #1619)
The purpose of this letter is to strongly urge you to bring criminal charges against Abbott Laboratories for illegally withholding from the FDA important information concerning eight deaths and other adverse effects of their big-selling obesity drug, sibutramine (Meridia), a drug we asked you to ban in March of this year.
Article in JAMA: Timing of new black box warnings and withdrawals for prescription medications (HRG Publication #1618)
Patient exposure to new drugs with unknown toxic effects may be extensive. Nearly 20 million patients in the United States took at least 1 of the 5 drugs withdrawn from the market between September 1997 and September 1998.5 Three of these 5 drugs were new, having been on the market for less than 2 years. Seven drugs approved since 1993 and subsequently withdrawn from the market have been reported as possibly contributing to 1002 deaths.
Testimony Before FDA Advisory Committee Concerning Alosetron (LOTRONEX) (HRG Publication #1617)
From our analysis of adverse event data from the FDA and the FDA briefing documents, as of 12/31/01 there have been 352 hospitalizations associated with the use of alosetron, the majority associated with gastrointestinal adverse reactions, 85 cases of ischemic colitis and 13 deaths, seven of which show a strong association with alosetron according to the FDA.
Petition to FDA to ban the diet drug sibutramine (MERIDIA) (HRG Publication #1613)
According to the FDA data base, since its launch in early 1998 sibutramine has now been associated with 29 deaths including 19 from cardiovascular adverse effects in people using this minimally effective drug.
Comments on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees; Draft Guidance (HRG Publication #1612)
An independent assessment of the nature and extent of a potential conflict of interest by the public involves not only the amount of fees paid by a sponsor, or the sponsor s competitor, to an advisory committee member but the length of time that the financial arrangement has existed. Disclosure of only one year of information is not sufficient to place a potential conflict in perspective. There should be at least two years of information disclosed to the public.
Direct-To-Consumer Advertising--Education or Emotion Promotion? (HRG Publication #1610)
Article by Sidney Wolfe, M.D. appearing in the New England Journal of Medicine on direct-to-consumer advertising of prescription drugs. Although increased access by patients to accurate, objective information about tests to diagnose and drugs to treat illnesses is an important advance, confusion arises when commercially driven promotional information is represented as educational
Letter to HHS Secretary Tommy Thompson calling on the government to seize 10 products containing synthetic ephedra (HRG Publication #1608)
We now have evidence that you are not only failing to protect Americans by banning a chemical that has more reports of deaths, heart attacks, strokes, cardiac arrhythmias, hypertension and seizure than all other food supplements combined, but that you have failed to seize at least 10 products made by at least nine dietary supplement manufacturers who are selling products that illegally contain synthetic ephedrine alkaloids under the guise of being legitimate dietary supplements.
Comments on: The Prescription Drug User Fee Act (PDUFA) (HRG Publication #1606)
Public Citizen=s position was then, and remains, that Congress must adequately fund the FDA using public money. Also, PDUFA=s second re-authorization in 1997, with its slavish deadlines and the accompanying ill-advised Food and Drug Administration Modernization Act (FDAMA) are examples of failed experiments in public policy.
Letter to American Medical Association urging their support of HRG petition to the FDA to ban dietary supplements containing ephedrine alkaloids (HRG Publication #1604)
Letter from Amer Ardati and Sidney Wolfe, M.D. to American Medical Association (AMA) president Michael Maves, M.D. requesting that they support HRG petition to the FDA to ban dietary supplements containing ephedrine alkaloids.
The Destruction of Medicine by Market Forces: Teaching Acquiescence or Resistance and Change? (HRG Publication #1603) Academic Medicine, January, 2002.
Medical schools have too often taught—actively, or passively by example—acquiescence to the increasing trends toward medicine as a business rather than teaching resistance to those trends in a manner consistent with medicine as a profession.
New Study Shows Low-Income, Minority Seniors Restrict Use of Prescription Drugs (HRG Publication #1602)
A study of a large, nationally representative sample of older Americans, to be published Dec. 4 in the Journal of General Internal Medicine, has found that 43 percent of those people without prescription drug coverage who are of minority ethnicity, have annual incomes of less than $10,000 and have out-of-pocket prescription drug costs of more than $100 per month reported restricting their use of prescribed medicines.
Letter to HHS Secretary on Pharmaceutical Research & Manufacturers of America Emergency Preparedness Task Force (HRG Publication #1600)
The PhRMA Task Force established at your behest is unquestionably a federal advisory committee subject to the Federal Advisory Committee Act (FACA). Accordingly, the HHS meetings with the Task Force violate FACA. Before a federal agency may use an advisory committee, FACA requires that the agency file a charter with the agency and with appropriate committees of Congress and provide a copy to the Library of Congress.
Letter urging the FDA to reject drug industry's request for liability disclaimer in its withdrawal of products containing phenylpropanolamine (PPA) (HRG Publication #1596)
The requested disclaimer would state that the withdrawal of PPA-containing drugs does not mean that the drugs were marketed negligently; this disclaimer is intended to gain some sort of protection for the companies from product liability suits.
Statement before the National Academy of Sciences on the Framework for Evaluating the Safety of Dietary Supplements (HRG Publication #1594)
Since at the heart of this problem is the irrational legal distinction that has been made between those pharmacologically active chemicals which are regulated as prescription or over-the-counter drugs and those which others call dietary supplements which I call drug supplements, eventually the same standards for safety and effectiveness must be adopted.
Petition to the Food and Drug Administration (FDA) requesting the ban of production and sale of dietary supplements containing ephedrine alkaloids. (HRG Publication #1590)
The Public Citizen Health Research Group, petitions the Food and Drug Administration (FDA) to ban the production and sale of dietary supplements containing ephedrine alkaloids. These dietary supplements include, but are not limited to, those containing ephedra, ephedra extract, and ma-huang. The grounds for FDA action are that these products present a significant or unreasonable risk of illness or injury under conditions of use suggested or recommended in the labeling
Petition to the FDA to issue strong warnings about the potential for certain cholesterol-lowering drugs to cause potentially life-threatening muscle damage. (HRG Publication #1588)
On the basis of these data, Public Citizen, representing 135,000 consumers nationwide, hereby petitions the FDA to add a black box warning and additional consistent bolded warnings about this serious problem to the label of all statins marketed in the United States.
Letter to HHS that supports a criminal investigation of Schering-Plough based on the possibility that the company knowingly shipped millions of asthma drug inhalers that may not have contained any active ingredients. (HRG Publication #1586)
As can be seen on the chart below, there were no deaths reported to the FDA to have occurred in users of Proventil or Warrick’s albuterol (generic version also manufactured by Schering-Plough) during the first three quarters of 1998. However, starting with a death that occurred in the fourth quarter of 1998 and continuing through the second quarter of 2000, there were a total of 17 deaths for which the Schering-Plough albuterol was listed as the primary suspect and in which there is a date of death.
Statement to the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee urging them to not approve the drug teriparatide. (HRG Publication #1585)
Based on our review of the Food and Drug Administration’s (FDA’s) assessment of the clinical data as well as several published articles on teriparatide efficacy, we do not believe that a sufficient basis for approving the drug in either men or women exists at the present time.
Testimony before the Food and Drug Administration Endocrine and Metabolic Drugs Advisory Committee Meeting on pramlintide (Symlin), recommending that it not be approved and that no additional clinical trials be done (HRG Publication #1584)
We opposed the approval of Symlin because of increased severe hypoglycemia with automobile driving-related adverse events including crashes and confusion while driving (statistically significant); most people required paramedic intervention, ER visits and IV glucose administration; there was one death in an auto crash in a patient getting pramlintide.
Testimony before the Subcommittee onConsumer Affairs Hearing, Senate Commerce Committee on Direct-to-Consumer (DTC) Advertising. (HRG Pubication #1583)
Because of the strong First Amendment in the U.S constitution, there is no way that DTC prescription drug advertising could ever be banned in this country. Having said that, however, there is an urgent need for more fine-tuned, better-staffed and much tougher government regulation of its content.
Letter to the FDA concerning tegaserod (Zelnorm), for constipation-predominant irritable bowel syndrome, and Novartis' reluctance to use ultrasound monitoring for their clinical trial subjects. (HRG Publication #1582)
tegaserod was associated with nine cases of ovarian cysts in women in clinical trials, eight of whom were taking tegaserod, all on the highest dose of this drug. All eight developed symptoms and five underwent hospitalization and surgery (one placebo patient had polycystic ovarian disease that did not require surgery
Letter to the Council for International Organizations of Medical Sciences (CIOMS) on their draft ethical guidelines involving human subjects. (HRG Publication #1580)
The current draft revision of the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects should be called what it is: a bald-faced and dangerous attempt to reverse the gains in the protection of research participants accomplished in the October 2000 version of the World Medical Association’s (WMA’s) Declaration of Helsinki (DOH).
Comments to the Food and Drug Administration on the proposed rule to revise the format of prescription drug professional product labeling (HRG Publication #1578)
We strongly support the creation of this section of the professional label. We do, however, recommend some minor modifications in the order in which information is presented. We believe that risk information (other bolded warnings [which are not now necessarily in the Highlights], contraindications and drug interactions) should appear higher up in the label, certainly before Dosage and Administration and How Supplied.
Letter to the Food and Drug Administration on a study stating a possible mechanism for the induction of ovarian cysts with the use of tegaserod (Zelmac) (HRG Publication #1577)
This is the first study to document the presence of the 5-HT4 receptor in ovarian tissue. As a result, we now have a plausible biological mechanism for the development of the observed ovarian cysts that occurred in women and rats.
Testimony before the Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee on apetition to relabel doxazosin (Cardura). (HRG Publication #1575)
As physicians being asked by patients to recommend drugs for the treatment of hypertension, it would be highly unlikely for you or for me, knowing what we now know, to recommend an alpha blocker such as Cardura as a first choice drug. More likely, we would relegate it to a fourth or lower choice drug, only after adequate trials of diuretics, beta blockers, or ACE inhibitors, alone and in combination, had been tried without success.
Letter to Senators Charles Grassley and Max Baucus referring to a paper presented at the Society of General Medicine annual meeting which discussed high drug costs and lack of drug coverage. (HRG Publication #1574)
After adjusting for multiple factors, minorities with no prescription coverage were almost ten times as likely as minorities with full coverage to restrict their medication usage due to cost. Similarly, among patients with incomes under $10,000 per year, those without prescription coverage were 14 times as likely to restrict their medication use as those with full coverage.
Letter in the Journal of the American Medical Association (JAMA) on problems with the Immune Response Corporation's HIV-1 vaccine study. (HRG Publication #1573)
We would like to point out that the IRC, which sponsored the study by Dr Kahn and colleagues, has been accused of previous attempts to improperly influence the presentation of scientific data on its HIV-1 Immunogen.
Letter to the FDA concerning the unresponsiveness of the agency's Freedom of Information Office to our requests (HRG Publication #1572)
Our success in obtaining this material has been steadily declining: the FOI office has become increasingly unresponsive to our requests and the CDER New and Generic Drug Approvals web site has been months to years behind in posting reviews.
Press release commenting on a National Bioethics Advisory Commission Report on international research which endorses standards lower than those of the October 2000 Declaration of Helsinki. (HRG Publication #1571)
The National Bioethics Advisory Commission (NBAC) today released a report that would put the U.S. in the unenviable position of endorsing ethics standards for American researchers that are lower than those required by the World Medical Association's Declaration of Helsinki.
Comments on the Food and Drug Adminstration's proposed rule concerning the disclosure of safety and effectiveness information about unapproved, investigational products--Human Gene Therapy(HRG Publication #1567)
Unfortunately, the FDA has chosen to limit its proposal for disclosure to only two interventions: 1.) gene therapy; and 2.) the transplantation of non-human tissue to human beings (xenotransplantation). Regrettably, this proposed rule as it applies to gene therapy follows the practice of the National Institutes of Health's (NIH) Recombinant DNA Advisory Committee (RAC) established 20 years ago. The FDA proposed rule is a long overdue attempt to harmonize its policy with that of the NIH.
Letter to the FDA concerning a memo from their Office of Post-marketing Drug Risk Assessment (OPDRA) that confirms and extends the dangers of the drug Lotronex (alosetron) for irritable bowel syndrome (HRG Publication #1566)
The updated AERS data we obtained, which extend through the end of calendar year 2000, now include a total of 63 people with ischemic colitis and 75 people with severe constipation (see graphs below).
Press Release commenting on Discovery Laboratories Inc. redesigning its study of surfactant (SURFAXIN) in Latin American. Under the new design, no infants will receive a placebo. (HRG Publication #1564)
Following a campaign by Public Citizen, Discovery Laboratories Inc. of Doylestown, Penn., has redesigned its study of Surfaxin, its brand of the drug surfactant, which is used to treat Respiratory Distress Syndrome (RDS) in premature infants. Under the new design, no infants will receive a placebo.
Comments on the Food and Drug Administration's decision to amend regulations regarding public disclosure of information distributed to advisory committee members for their review and consideration (HRG Publication #1562)
Public Citizen strenuously opposes this proposal by the Food and Drug Administration (FDA) to amend its regulations regarding the public disclosure of written information distributed to FDA advisory committee members for their review and consideration prior to an advisory committee meeting. The FDA's proposal would unnecessarily delay public access to important summary safety and efficacy information that is not exempt from disclosure about new drugs.
Letter to the Food and Drug Administration urging that it not approve tegaserod (Zelmac) because of its highly questionable efficacy and its potential to cause ovarian cysts (HRG Publication #1561)
Letter/Comments-Regulatory by Elizabeth Barbehenn, Ph.D. Peter Lurie, M.D., M.P.H. Sidney Wolfe, M.D. Letter to the Food and Drug Administration urging that it not approve tegaserod (Zelmac) because of its highly questionable efficacy and its potential to cause ovarian cysts
Testimony before the House of Representatives Committee on Government Reform Hearing on Dietary Supplements. (HRG Publication #1560)
When the first member of this committee or of Congress or their families, has a stroke, a fatal cardiac arrhythmia, or some other life-threatening adverse reaction to dietary supplements, perhaps there will be a belated reconsideration of the damage done by DSHEA. The law will then either be significantly modified or repealed so that pre-marketing safety and efficacy testing become the preferable alternative to post-marketing human experimentation.
Request to HHS to investigate charges against Schering-Plough for possibly knowingly shipping millions of asthma drug inhalers that may not have contained any active ingredient (HRG Publication #1559)
We urge you to launch an investigation into criminal charges against Schering-Plough based on the possibility that the company knowingly shipped millions of the 59 million units of albuterol-containing asthma drug eventually recalled between the time the company became aware of the seriously flawed manufacturing processes and the time the recall was finally accomplished.
Request to the Department of Health and Human Services to halt plans for unethical placebo-controlled study of drug for respiratory distress syndrome in Latin America unless it is redesigned to treat all patients (HRG Publication #1558)
We have learned that the Food and Drug Administration (FDA) is seriously considering endorsing the design of a drug-company study of a new surfactant drug in four Latin American countries in which a control group of 325 premature newborn infants with potentially fatal Respiratory Distress Syndrome (RDS) would be treated with placebos instead of a lifesaving and already FDA-approved surfactant drug.
Testimony before the FDA Arthritis Drugs Advisory Committee on the Nonsteroidal Anti-Inflammatory Drugs Celecoxib and Rofecoxib (HRG Publication #1555)
A second box warning about cardiovascular toxicity needs to be added. It should warn of the lack of platelet aggregation inhibition of the drugs which protects those at risk from an increased occurrence of heart attacks. In addition, the evidence which is rapidly accumulating about the heart damage caused by these drugs must be mentioned in this cardiovascular box warning.
Letter in Lancet on Alosetron for irritable bowel syndrome showing data manipulation in a company-sponsored clinical trial. (HRG Publication #1551)
Letter by Elizabeth Barbehenn, Ph.D. Peter Lurie, M.D., M.P.H. Sidney Wolfe, M.D. in Lancet on Alosetron for irritable bowel syndrome showing data manipulation in a company-sponsored clinical trial.
Letter to the National Bioethics Advisory Commission criticizing their draft report on ethics of research in developing countries. (HRG Publication #1550)
We are dismayed and deeply disappointed that the National Bioethics Advisory Commission (NBAC) has seen fit to radically alter its draft report on the ethics of research in developing countries at the last minute to no longer require review by a U.S. Institutional Review Board (IRB) of U.S. government-funded research in developing countries.
Letter to the National Institute for Clinical Excellence urging it to reconsider recommendations concerning Relenza use among people in the United Kingdom. (HRG Publication #1547)
We are extremely concerned that the recent recommendations concerning the influenza drug zanamivir (Relenza) by the National Institute for Clinical Excellence (NICE), of which you are the Chair, will jeopardize the health of many people in the United Kingdom.
Letter to the National Bioethics Advisory Commission regarding their report on the challenges of conducting research in developing countries. (HRG Publication #1545)
The result is a document that, in its most critical parts, emphasizes process over outcome, thus leaving a number of loopholes that are likely to be exploited by less-than-scrupulous researchers.
Letter to the Food and Drug Administration updating the number of cases of ischemic coliitis reported in our 8/31/00 petition. (HRG Publication #1544)
We have just obtained new information from the FDA about a sharp increase in the number of reported cases of ischemic colitis in people using alosetron. As of October 20th, reports received by the FDA now include an additional 28 cases of ischemic colitis, a more than doubling of the number of 26 cases we reported as of August 28th, for a total of 54 cases of ischemic colitis.
Comments on the final rule implementing the Prescription Drug Marketing Act of 1987/PDUFA. (HRG Publication #1543)
Unfortunately, Congress seriously erred in not mandating that all distributors, both unauthorized and authorized, be required to maintain such a pedigree for the drugs and bulk drug substances they sell. This has left the door open for unscrupulous distributors, even authorized ones, to launder counterfeit or substandard drugs that could be dispensed to an unsuspecting public.
Petition to the Food and Drug Administration requesting an immediate ban of all uses of Phenylpropanolamine (PPA) in over-the-counter products. (HRG Publication #1542)
We hereby petition the FDA for an immediate ban of all uses of phenylpropanolamine (PPA) in over-the-counter products (OTC) including as the active ingredient in appetite suppressants and as a decongestant in cough/cold preparations.
Testimony before the Food and Drug Administration NonPrescription Drugs Advisory Committee Meeting on Safety Issues of Phenylpropanolamine/PPA. (HRG Publication #1541)
[W]e are asking for an immediate ban of all uses of PPA in over-the-counter products (OTC) including appetite suppressants and cough/cold preparations.
Letter to the Editor in the Washington Post on modifications to the Declaration of Helsinki. (HRG Publication #1540)
The real story behind the revised research ethics document known as the Declaration of Helsinki [news story, Oct. 8] is that the declaration was reopened with the specific intent of watering it down so that patients in experiments in poor countries would not have to be provided with the best scientifically proven therapies.
News Release concerning a New England Journal of Medicine equivalency study on mother-infant HIV prevention trials done in Thailand without placebo. (HRG Publication #1539)
Had the researchers in the unethical studies designed theirs like the present study, hundreds of infants would have been saved because the mothers would have received a drug instead of placebo.
Letter to the World Medical Association on their new draft Declaration of Helsinki discussed at their October 2000 meeting. (HRG Publication #1538)
In most respects (see below), the draft Declaration is an improvement over the previous draft from May 2000 and a dramatic improvement over the disastrous version of March 1999. However, perhaps unintentionally, the current draft now makes no mention whatsoever of what interventions must be provided to patients during the trial, the very issue that prompted the revision of the Declaration in the first place.
Comments Before the Food and Drug Association's Dermatologic and Ophthalmic Drugs Advisory Committee meeting on Isotretinoin (Accutane). (HRG Publication #1537)
Where industry interests have been at stake, the FDA has been innovative in interpreting the Food, Drug and Cosmetic Act to get drugs such as clozapine, thalidomide and dofetilide on the market. It is time for the agency use the same creativity to protect the public's safety.
Comments before the Food and Drug Administration's Public Meeting on the Prescription Drug User Fee Act (PDUFA). (HRG Publication #1536)
The solution is clear - to prevent further incursion into the FDA's ability to effectively regulate prescription drugs requires public funding of the FDA. PDUFA-FDAMA is an unmistakable warning that user fees collected to finance the review of new drugs are bad public policy and that this scheme for funding the FDA must be regarded as a failed experiment.
Petition to the Food and Drug Administration to remove Lotronex from the market. (HRG Publication #1533)
Public Citizen, a nationwide consumer organization with about 145,000 members, hereby petitions the Food and Drug Administration to immediately remove from the market the drug alosetron (Lotronex, Glaxo Wellcome), a drug for the treatment of Irritable Bowel Syndrome (IBS) because, according to new information we have just received from the FDA as of August 28, 2000, it has been associated with a total of at least 26 cases of ischemic colitis.
Submission to the Food and Drug Administration Docket on drugs that present difficulties for compounding (HRG Publication #1532)
This change in the law has given compounding pharmacists an end run around the FDA approval process and has opened the door for unethical pharmacists to copy commercially available FDA-approved drugs and to perpetrate the dangerous quackery that is now rampant within the practice of pharmacy compounding.
Letter to the World Medical Association on their May 2000 version of the Declaration of Helsinki. (HRG Publication #1531)
However, we do remain deeply troubled by two aspects of the current draft Declaration.
Medical Education Service Suppliers (MESS): A Threat to Physician Education (HRG Publication #1530)
The MESS industry's revenue grew 19% between 1998 and 1999, totaling $643 million in U.S. revenue in 1999 for the 42 respondents (53%) who reported financial data. MESS's averaged $15 million in 1999 U.S. revenue (range: $0.35-98 million). A total of $289 million, or 45% of the total reported revenue, was earned through providing grand rounds, symposia, or publications-related activities, with $115 million earned through providing grand rounds-related services.
Letter sent to the Lancet on availability of information on thiazolidinediones. (HRG Publication #1534)
However, drug company websites are not the only, and certainly not the best, place to find unpublished data on drugs. Consulting readily available US governmental sources on the internet can lead to different conclusions regarding drug safety and efficacy. Using FDA data sources, we have just completed our own assessment of the thiazolinediones.
Comments in opposition to the Food and Drug Administration's Pharmacy Compounding Advisory Committee in opposition to the Pharmacy Compounding Provisions of the Food and Drug Administration Modernization Act (FDAMA) (HRG Publication #1529)
Public Citizen is opposed to the pharmacy compounding provisions of the Food and Drug Administration Modernization Act (FDAMA). These anti-scientific provisions of the law permit compounding pharmacists to conduct an "end run" around the FDA's drug approval process.
Testimony before the Food and Drug Administration's Endocrinologic/Metabolic and Non-Prescription Advisory Committee on prescription to over-the-counter switch. (HRG Publication #1528)
Even if the patient self-selection worked and arrived at a group of patients who met the defined eligibility criteria, these very criteria are seriously flawed. There is no evidence that the majority of those who are "eligible" for the drug will have any clinical benefit from taking 10 mg daily of Mevacor.
Letter to the American Journal of Public Health regarding inclusion of condoms and counseling in anti-HIV microbicide trials. (HRG Publication #1526)
Potts worries that more subjects would be needed for a study with condoms and counseling than for a study without these interventions. This can be addressed, however, by more actively recruiting participants and by using group sequential designs. Would Potts agree to a trial that was suboptimal scientifically in order to speed it up? If not, why is he willing to countenance studies that are suboptimal ethically for the same reason?
Comments at a Food and Drug Administration hearing on switching drugs from prescription to over-the- counter. (HRG Publication #1524)
Before discussing the issue of new classes of diseases for which prescription to OTC switches might be considered, I will review some principles which, I believe, can be helpful when thinking about any Rx-to-OTC switch. Then, using these principles, I will discuss some of the reasons why the switch of cholesterol-lowering drugs should be opposed. Seven Principles Which Need To Be Considered When Deciding on a Switch
Comments on the Department of Health and Human Services' Inspector General's Study on Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research (HRG Publication #1523)
We advocate a much stronger set of recommendations than is provided by the Inspector General's Report; in particular, we advocate promulgating strong new regulations based, in part, on models that are being successfully employed in various settings and which are described in the Report. (See last paragraph of our comments)
Letter to Center for Drug Evaluation and Research urging the Food and Drug Administration (FDA) to reject the approval of Uprima (apomorphine). (HRG Publication #1522)
We are writing to strongly urge the Food and Drug Administration (FDA) to reject the approval of Tap Holdings' (a joint venture with Abbott Labs) Uprima (apomorphine), a drug for the treatment of erectile dysfunction (ED). Despite the fact that this drug has been shown to be only marginally effective at the lower dose and to have significant, life-threatening toxicity at the higher dose...
Comments on the Department of Health and Human Services' Inspector General’s Study of Adverse Event Reporting for Dietary Supplements. (HRG Publication #1568)
We are very concerned about the dangerous inadequacy of FDA's adverse reaction reporting system for dietary supplements---wherein, for 1994 through 1999, the number of such reports filed with the American Association of Poison Control Centers (AAPCC) was 35,400, more than ten times higher than the approximately 3,000 reported to the FDA.
Study of the drug industry's performance in finishing required postmarketing research (Phase IV) studies. (HRG Publication #1520)
From 1990 through 1994 a total of 88 new molecular entities (NMEs) were approved which had at least one Phase IV commitment. Only 13 percent (11 of the 88) were classified by the FDA as complete as of December 1999 (see table 1, page 5). This means that for at least five and as long as 10 years after drug approval, all of the studies for 87 percent of these drugs had not been completed.
Letter to the Food and Drug Administration/FDA asking for the immediate withdrawal of Propulsid (cisapride) from the market. (HRG Publication #1519)
We have obtained new FDA reports concerning 23 additional U.S. deaths since the beginning of this year from cardiac arrhythmias or sudden cardiac arrest/death associated with the use of the heartburn drug, Propulsid.
Testimony regarding the FDA's categorization of "morning sickness" and "leg edema" during pregnancy as conditions not diseases which allows dietary supplement manufacturers to promote for these symptoms (HRG Publication #1517)
Under the dangerous provisions of DSHEA, that categorization allows dietary supplement manufacturers to promote products as treatments of those conditions without first proving that the products are safe and effective.
Letter to the Department of Health and Human Services urging that they implement and enforce the Code of Ethics for Government (HRG Publication #1516)
It is urgent for you and other leaders in HHS--and all government agencies--to re-read and strongly urge the implementation and enforcement of a 1958 Congressional Resolution entitled The Code of Ethics for Government Service (175 72 Stat B12, 1958) which states that "Any person in Government Service should put loyalty to the highest moral principles and to country above loyalty to persons, party or Government department."
Letter to the FDA requesting a criminal investigation of Warner Lambert/Parke Davis for what appears to be illegally delaying the submission of data known to the company before troglitazone was marketed. (HRG Publication #1515)
This letter is to request the opening of a criminal investigation of Warner-Lambert/Parke-Davis for what appears to be illegally delaying the submission of a compilation of data known to the company before marketing had begun--clearly showing troglitazone-induced liver toxicity--until after the drug was marketed.
Petition to the Food and Drug Administration requesting that it immediately require labeling for the diabetes drugs troglitazone (Rezulin), rosiglitazone (Avandia) and pioglitazone (Actos)(HRG Publication #1514)
Class efficacy issues include the lack of efficacy compared to previously available drugs, sulfonylureas, and the deterioration of blood sugar levels when patients are switched from other oral anti-diabetic drugs to the glitazones. Safety issues include liver toxicity, effects on heart function, weight gain, edema, anemia, low blood pressure, elevated lipid levels, and possible changes in progesterone levels.
Letter to the FDA concerning the United Kingdom's Committee on Safety of Medicine's recent warning about potentially serious drug interactions between St. John's Wort and a large number of other drugs. (HRG Publication #1513)
British physicians and patients are now being forcefully warned, for many more drugs than American physicians or patients, about potentially serious, clinically important drug interactions between the unregulated herbal St. John's Wort (Hypericum perforatum) and a large number of prescription drugs.
Comments on a Food and Drug Administration survey on the status of useful written prescription drug information for patients, requesting that it be redesigned. (HRG Publication #1512)
Because inadequate access to scientifically accurate drug information is a major cause of the inappropriate use of prescription drugs, resulting in serious personal injury to consumers and related costs to the healthcare system Public Citizen's Health Research Group strongly urges the following:
Letter to the Editor in the Washington Post on the death of Jesse Gelsinger in the University of Pennsylvania gene therapy study. (HRG Publication #1509)
Researchers are required to report adverse events in all clinical trials for experimental drugs to the Food and Drug Administration (FDA). Debate rages over whether gene therapy investigators should be required to report such events to the National Institutes of Health, which can disclose these events to the public, in addition to reporting them to the FDA, which carinot.
Letter to the UNAIDS program on their guidance document on ethical considerations in HIV preventive vaccine research. (HRG Publication #1508)
But the current version has instead opted for a non-prescriptive approach, simply laying out the options in many instances, and leaving large loopholes that we believe most researchers will exploit. The most serious of these are addressed below.
Letter to the Food and Drug Administration regarding their final regulations on dietary supplements and their definition of adverse effects of pregnancy. (HRG Publication #1507)
Now, the same agency seems to have thrown caution to the wind and appears willing to endanger unborn babies by pretending that medical conditions such as morning sickness and edema of pregnancy are not diseases, thereby allowing the marketing of dietary supplements/herbals that have not been tested for safety.
Letter to the Editor in the Journal of the American Medical Association in response to an article on the safety of Food and Drug Administration approved drugs which were withdrawn (HRG Publication #1502)
Letters-Science by Peter Lurie, M.D., M.P.H. Larry Sasich, Pharm.D., M.P.H. Letter to the Editor in the Journal of the American Medical Association in response to an article on the safety of Food and Drug Administration approved drugs which were withdrawn
Letter in The Lancet detailing unethical nevirapine trials. (HRG Publication #1500)
Although Laura Guay and colleagues' study on the effectiveness of nevirapine in reducing perinatal HIV-1 transmission offers hope for reducing the enormous global toll of HIV-1 infection, their work remains deeply unethical. For 14 months after an antepartum and intrapartum regimen of zidovudine was shown in Thailand to reduce HIV-1 transmission by 51%,2 Guay and colleagues continued to enrol participants without providing antepartum antiretroviral drugs.
Letter to the National Institutes of Health regarding their position on future studies of HIV-infected pregnant women since nevirapine was shown to reduce the risk of transmission. (HRG Publication #1498)
One might think that the development of this extremely cost-effective regimen ($40 per infant life saved) would result in an immediate change in NIH policy. But testimony delivered by Jack Killen of the National Institute of Allergy and Infectious Diseases before the National Bioethics Advisory Commission on September 16, 1999 suggests otherwise.
Letter to the Food and Drug Administration to immediately ban the antibiotic trovafloxacin (Trovan). (HRG Publication #1485)
we hereby petition the Food and Drug Administration (FDA) as authorized by 21 U.S.C. , section 355 (e) of the Federal Food, Drug and Cosmetic Act to immediately ban the widely-used antibiotic, TROVAN (trovafloxacin, Pfizer), before more patients die, require a liver transplant or are otherwise injured from liver toxicity caused by this drug.
Letter to the Editor in the Washington Post concerning dangerous drug information found on their web site entitled InteliHealth which is associated with Johns Hopkins University. (HRG Publication #1484)
Readers should be warned that The Post's new health Web site, www.washingtonpost.com/health, launched April 13, included potentially dangerous drug information. Information on the site, provided by Inteli-Health, Inc., in association with Johns Hopkins, is out-of-date and inaccurate. Here are just three examples:
Statement about a Food and Drug Adminstration article in the Journal of the American Medical Association regarding recently withdrawn drugs and the safety of newly approved drugs. (HRG Publication #1481)
None of these drugs were breakthrough drugs and the serious safety concerns should have prevented their approval in the cases of Redux, Posicor, and Duract and a much earlier market withdrawal for Seldane. FDA's conclusion that there is no problem associated with these drug safety withdrawals should not be taken seriously because to do so will continue to jeopardize the safety of American patients.
Citizen's petition with the National Women's Health Network to the Food and Drug Administration to change the labeling on tamoxifen (Nolvadex). (HRG Publication #1479)
When tamoxifen, a known human carcinogen, is prescribed to healthy women, there must be compelling evidence of great benefit. Although we are not convinced that the benefits of tamoxifen outweigh its risks in this population, tamoxifen has been approved and is now being prescribed for the reduction in incidence of breast cancer.
Statement before the Food and Drug Administration Endocrine and Metabolic Drugs Advisory Committee meeting advising them to withdraw troglitazone from the U.S. Market. (HRG Publication #1476)
John Doe was an otherwise healthy 45 year old Washington D.C. policeman who was started on Rezulin in the late summer of 1998, preceded by perfectly normal liver tests. Within a week after he started taking the drug, well before he was due for another liver test, he became seriously ill, was hospitalized at Johns Hopkins with acute liver failure.
Letter and documents sent to the Food and Drug Administration urging them to immediately recall all lots of Abbokinase because of possible contamination with infectious agents. (HRG Publication #1473)
The purpose of this letter is to strongly urge you to recall immediately all lots of Abbokinase, a widely-used clot-busting drug--$250 million in sales in 1998 for Abbott Laboratories of Abbokinase(1)--and to seize all raw materials and in-process precursors used to make Abbokinase, as recommended by FDA field officials, because of possible contamination with infectious agents.
Statement before the Food and Drug Administration's Cardiovascular and Renal Drugs advisory committee urging that they not approve dofetilide (Tikosyn) to prevent recurrent arrythmias. (HRG Publication #1472)
Despite not being allowed access to these data and the fact that the peer reviewed medical literature is not an adequate substitute for the FDA reviews of safety and efficacy we do have serious concerns based on a review of the published literature about the safety of dofetilide because of its proarrhythmic effects and association with torsade de points (a potentially life-threatening heart rhythm disturbance).
Letter to the Food and Drug Administration concerning a study in the New England Journal of Medicine amplifying our concerns about the safety of cilostazol (HRG Publication #1468)
Three members of the FDA's Cardiovascular and Renal Advisory committee voted against approving the drug due to these safety problems which were evident in the studies presented to that committee on July 9, 1998. These included abnormal electrocardiograms, increased heart rate, increased ventricular arrhythmias (premature ventricular contractions) and a suggestion, though not statistically significant, of increased mortality, even though the longest time studied on the drug was just six months.
Statement before the Food and Drug Administration's Arthritis Drugs Advisory Committee on the nonsteroidal anti-inflammatory drug celexocib. (HRG Publication #1465)
There needs to be clear evidence from comparative long-term, higher dose randomized trials in which celecoxib or any other COX-2 type of anti-inflammatory drug is compared to the least dangerous of these older drugs, ibuprofen, that there is a statistically significantly lower amount of serious GI complications such as perforations, ulcers or bleeding with the COX-2 inhibitor drug.
FDA Medical Officers Survey
Nineteen Medical Officers identified a total of 27 new drugs in the past three years that they reviewed that they thought should not have been approved but were approved. Five Medical Officers identified a total of six new drugs that they reviewed in the past three years that they thought should have been approved but were not approved.
Press Release Concerning FDA'S Approval of Tamoxifen to Reduce Incidence of Breast Cancer in Healthy Women Puts Women at Risk (HRG Publication #1464)
Public Citizen's Health Research Group finds it incredible that the Food and Drug Administration (FDA) has approved tamoxifen, a drug that is a known human carcinogen, to reduce the risk of breast cancer in women who are at a so-called high risk of the disease. Tamoxifen can induce tumors by altering a woman's DNA and may cause other types of cancers years later.
Letter to the FDA urging that they reject the application for approval of cilostazol (Pletal) as there are other remedies for a non-threatening condition (HRG Publication #1458)
We strongly urge you to reject the application for approval of cilostazol (Pletal), a drug to treat intermittent claudication, a chronic, non-life-threatening condition for which there are alternative solutions, including exercise, that do not involve the multitude of known and potentially life-threatening risks that exist with cilostazol.
HRG COMMENTS ON SECTION 406(B) OF THE FDA MODERNIZATION ACT OF 1997 (HRG Publication #1457)
The irony in this request for comments lies in the fact that the purpose of the FFDCA was consumer protection, while the clear intent of FDAMA '97 is to further the economic well-being of multinational pharmaceutical and medical device companies at the expense of the public's safety.
Letter to the Medicines Control Agency, United Kingdom, urging them to require important warnings on labeling of sildenafil/Viagra. (HRG Publication #1454)
Public Citizen's Health Research Group is writing to urge the Medicines Control Agency to require important warnings on the labeling of the drug sildenafil (Viagra) that have been omitted from the drug's labeling in the United States.
Letter to the Therapeutic Products Program in Canada urging them to require important warnings on the labeling of sildenafil/Viagra. (HRG Publication #1452)
Public Citizen has petitioned the United States Food and Drug Administration (FDA) on July 1, 1998 and again on August 20, 1998 to correct the dangerously deficient labeling of sildenafil in the U.S. These two petitions are attached for your reference.
Letter to the Food and Drug Administration urging them to immediately convene an advisory committee to review various serious problems related to the use of sildenafil/Viagra. (HRG Publication #1451)
One purpose of this letter is to demand that the FDA immediately convene a meeting on Viagra of its cardiovascular advisory committee--a committee which was completely bypassed during the dangerously-rushed six months between the submission of the new drug application for Viagra to the FDA and its approval.
Petition to the Food and Drug Administration to ban troglitazone/Rezulin due to its causing several cases of liver failure. (HRG Publication #1449)
We have obtained information from the FDA that as of June 5, 1998, there had been at least 21 deaths from liver failure and three patients requiring liver transplants caused by the recently-approved diabetes drug, troglitazone (Rezulin-Parke- Davis/Warner Lambert).
Petition to the Food and Drug Administration to change the labeling and other sources of information on sildenafil/Viagra to reflect problems with the drug. (HRG Publication #1445)
The purposes of this letter are to petition FDA to change the labeling and other sources of information about Viagra to add important information about the drug's dangers currently missing from such sources and to warn doctors and patients that a substantial proportion of patients using the drug are unwittingly using it to treat impotence or other types of sexual dysfunction which are probably adverse reactions caused or worsened by other drugs known to impair sexual function.
Statement on the withdrawal of mibefradil/Posicor from the market. (HRG Publication #1441)
Mibefradil (Posicor) is an example of the risks that the American public will continue to face in the future because of the flood of new drugs that the FDA has rushed to approve in the last several years.
Response to the Institute of Medicine's Report on Halcion. (HRG Publication #1431)
The Institute of Medicine (IOM) report, done in a hurried manner, is a waste of taxpayers dollars in that many of the questions it was asked/paid to answer by the Food and Drug Administation (FDA), had already been answered by the FDA before the committee's process had barely begun.
Statement on misleading direct-to-consumer advertising by Schering for loratadine (Claritin). (HRG Publication #1426)
Predictably, it has taken only 11 days for a major drug company to violate Federal law and regulations with misleading direct-to-consumer (DTC) TV ads for a prescription drug, supporting the contention that the true purpose of TV ads for prescription drugs is to sell products, not, as the drug industry would have people believe, to educate consumers.
Comments supporting the Drug Enforcement Administration's proposed placement of butorphanol (Stadol and Stadol Nasal Spray) into Schedule IV. (HRG Publication #1422)
Public Citizen strongly supports this action by the Drug Enforcement Agency (DEA) to regulate all forms of the potent opioid pain reliever butorphanol as a controlled substance. Butorphanol's classification under the Controlled Substance Act (CSA) will finally inform doctors and consumers of this drug's potential addicting properties.
Letter to Senators urging them to vote against an amendment to S.830 which would make it legal for companies to promote drugs and medical devices for unapproved uses. (HRG Publication #1420)
The amendment, which would make it legal, for the first time, for companies to promote drugs and medical devices for unapproved uses, can most accurately be described as the killer fen-phen amendment , because it would have made legal the promotion of an even greater use of this already occurred without the manufacturers being able to promote this deadly combination.
Comments before the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee on orlistat (Xenical) for the treatment of obesity. (HRG Publication #1417)
It is troubling that important information about orlistat has been kept secret, and the time allotted for public participation is in the hour before any presentations will reveal what is known about orlistat. Scheduling public comment later in the meeting, after presentation of what we believe are numerous studies involving large numbers of subjects(2), without the time to carefully evaluate these data is little better than keeping the data secret.
Letter to the Department of HHS concerning their funding of unethical trials which administer placebos to HIV-infected pregnant women through NIH and the Centers for Disease Control. (HRG Publication #1415)
Unless you act now, as many as 1,002 newborn infants in Africa, Asia and the Caribbean will die from unnecessary HIV infections they will contract from their HIV-infected mothers in nine unethical research experiments funded by your Department through either the National Institutes of Health (NIH) or the Centers for Disease Control and Prevention (CDC).
Editorial by Sidney M. Wolfe in the 10/96 Vol. 11 Issue of the Journal of General Internal Medicine Entitled Why Do American Drug Companies Spend More than $12 Billion a Year Pushing Drugs? Is it Education or Promotion? (HRG Publication #1403A)
Enclosed is an article I have written which will appear in the Lancet this Saturday, September 7th. It discusses the demeaning way, inside the drug industry, that physicians are viewed, brainwashed and conquered.
Petition to Require a Warning on All Fluoroquinolone Antibiotics (HRG Publication #1399)
Based on more than 130 reports of tendon inflammation (many involving rupture), most frequently involving the Achilles tendon, in persons using the widely-prescribed class of antibiotics known as fluoroquinolones, Public Citizen, representing consumers nationwide, hereby petitions the F.D.A. to add a warning about this serous problem to the label of all fluoroquinolone antibiotics marketed in the United States. These include:
Letter to FDA Commissioner David Kessler Urging Him to Begin a Safety and Efficacy Review of All Pharmaceuticals Marketed in the US Prior to 1938 (including Synthroid) (HRG Publication #1393)
In 1978, the last year for which data are available, the FDA estimated that 240 pre-1938 pharmaceuticals were being manufactured. Of these, only 45 had submitted safety and efficacy data in New Drug Applications, in most instances not for all dosage forms of the medication.
Statement by Sidney M. Wolfe, MD, Concerning Petition to Repeal DOD/FDA Regulation Allowing Waiver for Informed Consent for Experimental Drugs (HRG Publication #1392)
Statement - STATEMENT BY SIDNEY M. WOLFE, MD, CONCERNING PETITION TO REPEAL DOD/FDA REGULATION ALLOWING WAIVER FOR INFORMED CONSENT FOR EXPERIMENTAL DRUGS
Letter to FD Commissioner David Kessler Urging Him to Delay Approval of the Weight Control Drug Dexfenfluramine (HRG Publication #1389)
Public Citizen, representing 90,000 consumers, urges the FDA to delay approval for the weight control drug dexfenfluramine (Redux, Wyeth-Ayerst/American Home Products) until questions about its effectiveness, public health benefit and most importantly its safety are resolved.
FDA Hearing on Calcium Channel Blockers
On November 9, 1995 Public Citizen's Health Research Group petitioned the FDA to put warning labels on all calcium channel blocker drugs because of the rapidly mounting evidence that a variety of these drugs, used for different medical purposes, including the treatment of hypertension and angina, actually increase rather than decrease the risk of death.
HRG Citizen's Petition to Require a Warning on All Calcium Channel Blocking Drugs (HRG Publication #1378)
This prescribing continues in the absence of evidence that these drugs [calcium channel blockers] prevent heart attack, heart failure, strokes or death and in the face of mounting evidence of their hazards. The FDA should also require patient package inserts for all calcium channel blockers.
Letter to David Kessler, FDA Commissioner, Urging Him to Investigate Allergan, the Makers of Polytrim Ophthalmic Solution (HRG Publication #1376)
Less than a month after we wrote to you requesting that you investigate the pharmaceutical company Bayer for sponsoring a "Dear Doctor" letter concerning the widely-prescribed calcium channel blocker drug nifedipine (Adalat, Adalat CC) without disclosing that they had orchestrated and paid for the letter's mailing, we are writing about a similar circumstance, this time involving Allergan, the makers of Polytrim ophthalmic solution.