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adverse effects of drugs

• Adverse Drug Reactions [hide all summaries]
  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.
• Allergy and Hayfever [hide all summaries]
  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.
• Antipsychotic Drugs: Dangerously Overused [hide all summaries]
  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.
• Arthritis and Inflammation [hide all summaries]
  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.
• Benign Prostatic Hypertrophy (BPH) [hide all summaries]
  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.
• Constipation [hide all summaries]
  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.
• Cough and Cold [hide all summaries]
  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.
• Depression: When are Drugs Called For And Which Ones Should You Use? [hide all summaries]
  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:
• Diabetes Prevention and Treatment [hide all summaries]
  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.
• Diarrhea [hide all summaries]
  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).
• Dietary and Herbal Supplements [hide all summaries]
  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).
• Drug-Induced Diseases [hide all summaries]
  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.
• Elevated Cholesterol Levels [hide all summaries]
  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.
• Fluoroquinolones [hide all summaries]
  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.
• High Blood Pressure [hide all summaries]
  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.
• Hormone Replacement Therapy [hide all summaries]
  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.
• Migraine Headaches [hide all summaries]
  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.
• Muscle Relaxants [hide all summaries]
  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.
• Narcotics [hide all summaries]
  Most of the time when someone is able to swallow, they should first try a nonnarcotic drug such as aspirin taken by mouth. If aspirin alone is not effective, it can be combined with a narcotic, 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 narcotic, while causing fewer adverse effects.
• Oral Contraceptives [hide all summaries]
  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.
• Osteoporosis [hide all summaries]
  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.
• Penicillins and Cephalosporins [hide all summaries]
  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.
• Salicylates and Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) [hide all summaries]
  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.
• Sleeping Pills and Tranquilizers [hide all summaries]
  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.
• Tetracyclines [hide all summaries]
  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.
• Ulcers and Gastroesophageal Reflux Disease (GERD) [hide all summaries]
  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.
• Vitamins and Minerals [hide all summaries]
  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.

• Life-Threatening Liver Toxicity of Avandia Shown in New Public Citizen Research Published in Peer-Reviewed Medical Journal [hide all summaries]
  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).
• Letter Urging the FDA to Halt its Review of Prasugrel (HRG Publication #1876) [hide all summaries]
  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) [hide all summaries]
  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.
• Statement of Dr. Peter Lurie on FDA granting Public Citizen's Petition that Sought to Warn Patients and Doctors about the Dangers of Botulinum Toxin (HRG Publication #1870) [hide all summaries]
  Statement of Peter Lurie, MD, MPH, Deputy Director, Health Research Group, Public Citizen.
• 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) [hide all summaries]
  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 [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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.
• Testimony before FDA hearing on cough and cold remedies for children (HRG Publication #1845) [hide all summaries]
  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 FDA Re: Content and Format of Labeling for Human Prescription Drug and Biological Products: Requirements for Pregnancy and Lactation Labeling (HRG Publication #1841) [hide all summaries]
  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 [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  A meta-analysis assesses the safety of blood substitutes and the risk of heart attack and death when these products are used.
• Congress Must Act Quickly to Address Growing Crisis At the Food and Drug Administration [hide all summaries]
  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's Botox Warning Falls Short [hide all summaries]
  Statement of Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen
• Stricter Warnings Needed for Botox, Myobloc Injections [hide all summaries]
  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 [hide all summaries]
  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 [hide all summaries]
  Statement by Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group
• Antibiotic Leads to Tendon Ruptures; FDA Ignores Risks [hide all summaries]
  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) [hide all summaries]
  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 [hide all summaries]
  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.
• Children Under 12 Should Not Be Given Cough, Cold Medications, Public Citizen Tells FDA [hide all summaries]
  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).
• Diabetes Drug Avandia Should Be Removed From the Market, Public Citizen Tells FDA Advisory Committee [hide all summaries]
  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.
• European Drug Regulatory Authority Should Remove Arthritis Drug Etoricoxib and Weight Loss Drug Rimonabant From European Market [hide all summaries]
  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.
• Weight Loss Drug Rimonabant Can Cause Serious Physical and Psychological Harm and Birth Defects, Public Citizen Tells FDA [hide all summaries]
  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.
• FDA Knew of Avandia’s Dangers Nearly Five Years Ago, Memo Shows [hide all summaries]
  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.
• Evidence Confirms Public Citizen’s Warnings About the Risks of Popular Diabetes Drug Avandia [hide all summaries]
  Statement by Sidney Wolfe, MD, Director of Health Research Group at Public Citizen
• FDA Should Not Approve Painkiller Dubbed “Offspring of Vioxx” [hide all summaries]
  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.
• FDA Should Not Have Approved Tegaserod (Zelnorm); Public Citizen Warned of Dangers When Drug Was Considered in 2001 [hide all summaries]
  Statement of Sidney Wolfe, MD, director of Public Citizen’s Health Research Group
• FDA Approval of Over-the-Counter Orlistat Is Reckless [hide all summaries]
  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) [hide all summaries]
  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.
• FDA Proposal for Painkiller Warning Is Decades Late [hide all summaries]
  Statement of Dr. Peter Lurie, Deputy Director of Public Citizen’s Health Research Group
• Public Citizen Petitions the FDA to Include a Black Box Warning on Fluoroquinolone Antibiotics (HRG Publication #1781) [hide all summaries]
  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.
• Update on Use of Growth Hormone for Normal Small Children: Discussed on CNN International June 20, 2006 (HRG Publication #1774) [hide all summaries]
  Update on Use of Growth Hormone for Normal Small Children: Discussed on CNN International June 20, 2006 (HRG Publication #1774)
• Statement Before the Institute of Medicine Committee on Developing Cancer Biomarkers: A Case Study Involving ACF/orlistat (HRG Publication #1773) [hide all summaries]
  Why Not for Harm Prevention as Well? A Case Study Involving ACF/orlistat
• Supplement to petition to ban diet drug orlistat (XENICAL). Additional information provided about pre-cancerous changes to the colon (HRG Publication #1771) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  Petition to the FDA to Immediately Ban the Antibiotic Gatifloxacin (Tequin) (HRG Publication #1768)
• Petition to the FDA to immediately remove the diet drug orlistat (XENICAL) from the market (HRG Publication #1764) [hide all summaries]
  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) [hide all summaries]
  Petition to FDA to ban all propoxyphene (DARVON) products; prescription painkiller causes many fatalities (HRG Publication #1762)
• Testimony Before the FDA Advisory Committees on Possible Switch of Orlistat (XENICAL) to OTC Status (HRG Publication #1760) [hide all summaries]
  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)
• 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) [hide all summaries]
  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.
• 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) [hide all summaries]
  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 (SMART) study (HRG Publication #1752) [hide all summaries]
  Misleading data analyses in salmeterol (SMART) study (HRG Publication #1752)
• Testimony before FDA Advisory Committee on new diabetes drug Muraglitazar (PARGLUVA): Risks outweigh the benefits. (HRG Publication #1749) [hide all summaries]
  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) [hide all summaries]
  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?
• Drugs and breastfeeding--a letter to the Editor of Australian Prescriber (HRG Publication #1740) [hide all summaries]
  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) [hide all summaries]
  Supplement to Petition to the FDA to withdraw the lung cancer drug gefitinib (Iressa) (HRG Publication #1739)
• Bextra Ban a Good Step, But FDA Should Pull Celebrex Too (HRG Publication #1734) [hide all summaries]
  Statement of Sidney M. Wolfe, M.D., Director, Public Citizen's Health Research Group
• Statin-associated rhabdomyolysis (HRG Publication #1733) [hide all summaries]
  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*
• Petition to the FDA to remove the Attention Deficit drug pemoline (CYLERT) from the market because of liver toxicity (HRG Publication #1731) [hide all summaries]
  Petition to the FDA to remove the Attention Deficit drug pemoline (CYLERT) from the market because of liver toxicity (HRG Publication #1731)
• Statement of Sidney Wolfe, M.D. regarding the FDA's decision to leave Crestor on the market (HRG Publication #1730) [hide all summaries]
  Statement of Sidney Wolfe, M.D. regarding the FDA's decision to leave Crestor on the market (HRG Publication #1730)
• Letter to FDA shows that Crestor has higher rates of rhabdomyolysis compared to other statins (HRG Publication #1729) [hide all summaries]
  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) [hide all summaries]
  Painkillers and Terrorism. Letter to the Editor of the New York Times on Cox 2 Painkillers (HRG Publication #1727)
• Testimony to FDA on Dangers of Cox-2 Drugs (HRG Publication #1725) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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
• Testimony Before the FDA Reproductive Health Advisory Committee Concerning the Transdermal Testosterone Patch (HRG Publication #1713) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  Vioxx, Other “Super Aspirins” Are Super Disasters – Other Cox-2 Alternatives Have Safety Problems Too (HRG Publication #1707)
• Testimony before the FDA's Cardiovascular and Renal Drugs Advisory Committee Hearing on Ximelagatran--September 10, 2004 (HRG Publication #1706) [hide all summaries]
  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 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) [hide all summaries]
  Public Citizen Calls for Criminal Investigation of AstraZeneca. Company Illegally Delayed Submitting Reports of Serious Adverse Reactions to Cholesterol Drug Crestor. (HRG Publication #1703)
• Letter to NIH Director questioning the propriety of the actions of a senior NIH scientist who was a consultant for AstraZeneca. (HRG Publication #1700) [hide all summaries]
  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) [hide all summaries]
  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,
• Testimony before FDA advisory committee concerning alosetron (Lotronex) (HRG Publication #1697) [hide all summaries]
  New Data Reconfirms Dangers of Controversial Drug Lotronex
• Petition to the FDA to remove the cholesterol-lowering drug rosuvastatin (CRESTOR) from the market (HRG Publication #1693) [hide all summaries]
  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.
• 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) [hide all summaries]
  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)
• Supplement to Petition to the FDA to ban the anitidepressant drug nefazadone (SERZONE) (HRG Publication #1681) [hide all summaries]
  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.
• Petition supplement to FDA outlining the rising number of cardiovascular events associated with the diet drug sibutramine (MERIDIA) (HRG Publication #1675) [hide all summaries]
  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.
• Statement of Sidney M. Wolfe, MD before the FDA Endocrinologic and Metabolic Drugs Advisory Committee Hearing on Rosuvastatin (HRG Publication #1669) [hide all summaries]
  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.
• 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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  Twenty-Year Chronology of Events Concerning Ephedrine Alkaloids, released in conjunction with publication of article in Science magazine: Ephedra Scientific Evidence Versus Money/Politics
• Petition to the FDA to Ban the Antidepressant Drug Nefazadone (SERZONE) (HRG Publication #1657) [hide all summaries]
  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.
• Letter to FDA addressing Dr. Gary Firestein's comments concerning HRG's petition to remove ARAVA from the market (HRG Publication #1644) [hide all summaries]
  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) [hide all summaries]
  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.
• Statement on Safety Issues Related to Acetaminophen Before the Nonprescription Drugs Advisory Committee (HRG Publication #1639) [hide all summaries]
  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).
• Letter to HHS Secretary Tommy Thompson that raises ethical concerns about the “Alzheimer’s Disease Anti-Inflammatory Prevention Trial” (ADAPT) (HRG Publication #1637) [hide all summaries]
  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.
• Allowing Lotronex Back on the Market Will Endanger Patients (HRG Publication #1622) [hide all summaries]
  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.
• 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) [hide all summaries]
  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.
• Testimony Before FDA Advisory Committee Concerning Alosetron (LOTRONEX) (HRG Publication #1617) [hide all summaries]
  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) [hide all summaries]
  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.
• Letter urging the FDA to reject drug industry's request for liability disclaimer in its withdrawal of products containing phenylpropanolamine (PPA) (HRG Publication #1596) [hide all summaries]
  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.
• 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) [hide all summaries]
  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.
• 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) [hide all summaries]
  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) [hide all summaries]
  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.
• 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) [hide all summaries]
  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 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) [hide all summaries]
  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 a petition to relabel doxazosin (Cardura). (HRG Publication #1575) [hide all summaries]
  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 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) [hide all summaries]
  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).
• 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) [hide all summaries]
  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) [hide all summaries]
  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.
• Testimony before the FDA Arthritis Drugs Advisory Committee on the Nonsteroidal Anti-Inflammatory Drugs Celecoxib and Rofecoxib (HRG Publication #1555) [hide all summaries]
  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 to the National Institute for Clinical Excellence urging it to reconsider recommendations concerning Relenza use among people in the United Kingdom. (HRG Publication #1547) [hide all summaries]
  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 Food and Drug Administration updating the number of cases of ischemic coliitis reported in our 8/31/00 petition. (HRG Publication #1544) [hide all summaries]
  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.
• Testimony before the Food and Drug Administration NonPrescription Drugs Advisory Committee Meeting on Safety Issues of Phenylpropanolamine/PPA. (HRG Publication #1541) [hide all summaries]
  [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.
• 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) [hide all summaries]
  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.
• Comments Before the Food and Drug Association's Dermatologic and Ophthalmic Drugs Advisory Committee meeting on Isotretinoin (Accutane). (HRG Publication #1537) [hide all summaries]
  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.
• Petition to the Food and Drug Administration to remove Lotronex from the market. (HRG Publication #1533) [hide all summaries]
  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.
• Letter to Center for Drug Evaluation and Research urging the Food and Drug Administration (FDA) to reject the approval of Uprima (apomorphine0. (HRG Publication #1522) [hide all summaries]
  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) [hide all summaries]
  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.
• Letter to the Food and Drug Administration/FDA asking for the immediate withdrawal of Propulsid (cisapride) from the market. (HRG Publication #1519) [hide all summaries]
  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.
• 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) [hide all summaries]
  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) [hide all summaries]
  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 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) [hide all summaries]
  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 to the Food and Drug Administration to immediately ban the antibiotic trovafloxacin (Trovan). (HRG Publication #1485) [hide all summaries]
  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.
• 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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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.
• 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) [hide all summaries]
  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 regarding an ad for troglitazone (Rezulin) in a Hispanic publication [hide all summaries]
  Enclosed is an extremely misleading direct-to-consumer (DTC) advertisement that lacks fair balance for the dangerous diabetes drug troglitazone (Rezulin), made by Parke Davis, a division of Warner Lambert, of Morris Plains, NJ. This ad, with the good news and promotional information in Spanish but the official labeling with warnings and risks in English
• 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) [hide all summaries]
  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) [hide all summaries]
  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.
• Press Release Concerning FDA'S Approval of Tamoxifen to Reduce Incidence of Breast Cancer in Healthy Women Puts Women at Risk (HRG Publication #1464) [hide all summaries]
  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) [hide all summaries]
  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.
• Letter to the Medicines Control Agency, United Kingdom, urging them to require important warnings on labeling of sildenafil/Viagra. (HRG Publication #1454) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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) [hide all summaries]
  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.
• HRG Letter to David Kessler Regarding Lancet Ad Discussing Demeaning Ways That Physicians Are Viewed (HRG Publication #1403) [hide all summaries]
  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. By identifying the hippocampus as the "prescription-writing center of the brain", McAdam, advertising its marketing/mesmerizing skills to drug company marketing departments, offers to help sell drugs to doctors by brainwashing them into believing whatever drug is being advertised is superior.
• HRG Comments on Direct-to-Consumer Prescription Drug Promotion dated 5/14/96. (HRG Publication #1400) [hide all summaries]
  We are aware of no valid scientific evidence that suggests DTC prescription drug advertising leads to better health outcomes for the public. On the contrary, based on the prevailing evidence presented above unregulated DTC advertising as currently allowed may induce needless economic hardship and perhaps physical harm to consumers.
• Petition to Require a Warning on All Fluoroquinolone Antibiotics (HRG Publication #1399) [hide all summaries]
  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:
• Statement by Sidney M. Wolfe, MD, Concerning Petition to Repeal DOD/FDA Regulation Allowing Waiver for Informed Consent for Experimental Drugs (HRG Publication #1392) [hide all summaries]
  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) [hide all summaries]
  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 [hide all summaries]
  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) [hide all summaries]
  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.
• Statement of Paul D. Stolley, MD, MPH that comments on the FDA Risk-Management Concept Papers (HRG Publication #1663) [hide all summaries]
  

• Backsliding on Childhood Immunization [hide all summaries]
  (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.
• What Happened in U.S. Health Care in 2007? [hide all summaries]
  (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.
• Research as Public Relations: Antidepressants and Suicide in Youth [hide all summaries]
  (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.
• Diet Drug Poses Risks, Few Benefits [hide all summaries]
  (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.
• Sleight-of Hand: Merck Tried to Reformulate Vioxx in 2000 While Denying Risk [hide all summaries]
  (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.
• A Reminder About The Dangers of Aspirin and Reyes's Syndrome [hide all summaries]
  (October 2003)
  Children and teenagers should not use aspirin when they have the flu.
• Meridia — Weight Loss or Health Loss? [hide all summaries]
  (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).
• Drug Safety Withdrawals: Who is Responsible for Notifying Patients? [hide all summaries]
  (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.
• FDA Caves In to Industry, Fails to Adequately Address Tylenol Overdoses [hide all summaries]
  (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.
• Will a Vitamin a Day Keep the Doctor Away? [hide all summaries]
  (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.
• Outrage: Department of Health and Human Services Fails to Ban Ephedra or Issue Adequate Warnings [hide all summaries]
  (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.
• Outrage: Possible Corruption at the American Heart Association [hide all summaries]
  (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.
• Outrage: Do Not Use Ephedra [hide all summaries]
  (October 2001)
  This Is a Dangerous Substance and Should Be Taken off the Market.
• COX-2 Inhibitors Vioxx and Celebrex: Keep Staying Away--It Gets Worse [hide all summaries]
  (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.

• A Review of Exenatide (BYETTA) for Type-2 Diabetes [hide all summaries]
  (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.
• An Update on the HPV Vaccine GARDASIL [hide all summaries]
  (November 2009)
  The article updates our previous information on the benefits and risks of this important vaccine.
• Insulin Glargine (LANTUS) and Cancer: Is There a Link? [hide all summaries]
  (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.
• Milnacipran (SAVELLA) Fails to Alleviate Fibromyalgia Pain, Has Safety Concerns [hide all summaries]
  (September 2009)
  This article raises serious questions about the the limited effectiveness of SAVELLA and reviews evidence of serious toxicity.
• A Review of Shingles Vaccine ZOSTAVAX [hide all summaries]
  (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.
• New Study Further Links Alzheimer's Drugs to Serious Side Effects [hide all summaries]
  (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.
• Herbal Medicines for Menopausal Symptoms? Hang Onto Your Wallet and Your Health [hide all summaries]
  (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 [hide all summaries]
  (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.
• Another Chapter in the Long History of Exposing the Dangers of the Most Popular Drug in America [hide all summaries]
  (July 2009)
  This article documents how long it has taken the FDA to fully implement a reccomendation 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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• What Aspirin Dose Is Safest and Most Effective for Preventing Heart Disease? [hide all summaries]
  (May 2009)
  This article discusses the fairly narrow range of daily aspirin doses most safe and effective for preventing heart disease.
• WARNING: MRI Scans May Burn Patients Wearing Transdermal Drug Patches [hide all summaries]
  (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.
• LOVAZA: Limited Use Drug for Lowering Trigylcerides [hide all summaries]
  (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 [hide all summaries]
  (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.
• Drug-Induced Cognitive Impairment: Part One [hide all summaries]
  (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.
• Update: Oral Sodium Phosphate Used as Preparation for Colonoscopy Can Cause Kidney Damage [hide all summaries]
  (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.
• Long-term Use of Bisphosphonates for Osteoporosis [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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.
• Update on Drugs that Can Cause High Blood Potassium [hide all summaries]
  (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.
• Muscle Injury From Use of Simvastatin (ZOCOR) with Amiodarone (CORDARONE) [hide all summaries]
  (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 [hide all summaries]
  (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
• Botox, Mark Spitz, Nadia Comaneci vs. Willie Nelson [hide all summaries]
  (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".
• FDA Must Warn Patients Taking Fluoroquinolone Antibiotics of Possible Tendon Ruptures [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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.
• The Growth Hormone Craze: Why it Should Be Used only Rarely [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• A Review of Modafinil (PROVIGIL) For Narcolepsy [hide all summaries]
  (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.
• Drug-Induced Eye Toxicity: 62 Drugs That Can Cause Eye Disease [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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? [hide all summaries]
  (March 2008)
  This article explains what autism is and analyzes the latest evidence concerning its alleged link to mercury from childhood vaccines.
• Ibuprofen Can Reduce Aspirin’s Protective Effect Against Heart Attacks and Strokes [hide all summaries]
  (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.
• Is Less More? New Study Challenges Conventional Thought on Desirable Cholesterol Levels, Links Very Low Cholesterol to Cancer [hide all summaries]
  (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 [hide all summaries]
  (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.
• Painkiller DARVOCET Now Phased Out of U.K. Market; Still Widely Prescribed in the U.S. [hide all summaries]
  (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.
• Taking TOPAMAX to Treat Alcoholism Could Have Serious Consequences [hide all summaries]
  (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) [hide all summaries]
  (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.
• New European Warnings and Restrictions on Painkiller Piroxicam (FELDENE): FDA Fails to Issue New Warning [hide all summaries]
  (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.
• EU Warns About BOTOX Dangers: Why has the US failed to inform its residents? [hide all summaries]
  (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.
• Drug-Induced Diseases: Part 2 [hide all summaries]
  (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.
• A Review of Varenicline (CHANTIX) To Quit Smoking [hide all summaries]
  (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.
• Pharmacists Ordered to Distribute Medication Guides About Serious Heart, Psychiatric Problems Linked to Attention Deficit Drugs [hide all summaries]
  (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) [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• New Findings: AVANDIA Poses Risks of Heart Attacks, Heart Failure [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• FDA Requests New Safety Warnings for AMBIEN (Zolpidem), Other Sleeping Pills [hide all summaries]
  (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 [hide all summaries]
  (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.
• Dangerous Abnormal Behavior In Children And Adolescents Treated With Flu Drug Oseltamivir (TAMIFLU) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• Life-Threatening Adverse Effects and Deaths Reported in Patients Using Methadone (DOLOPHINE) for Pain Relief [hide all summaries]
  (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 [hide all summaries]
  (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.
• Adverse Drug Reactions Cause 1.4 Million Emergency Room Visits in 2004 and 2005 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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.
• The Case Against The Diabetes Drug Rosiglitazone (AVANDIA) [hide all summaries]
  (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.
• FDA Issues Stronger Warnings for ADHD Stimulants; Warnings Don’t Go Far Enough [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• A Review of Ibandronate (BONIVA) For Osteoporosis [hide all summaries]
  (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 [hide all summaries]
  (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.
• New Study Links Signs of Possible Liver Damage to Lower Doses of Acetaminophen (TYLENOL), Supporting Previous Research [hide all summaries]
  (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) [hide all summaries]
  (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) [hide all summaries]
  (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).
• FDA Public Health Advisory: Birth Defects with High Blood Pressure-Lowering Drugs Containing Angiotensin-Converting Enzyme (ACE) Inhibitors [hide all summaries]
  (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.
• Deaths In Children Using Promethazine (PHENERGAN) Increase; FDA Issues a Safety Alert and a Stronger Black Box Warning [hide all summaries]
  (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 [hide all summaries]
  (August 2006)
  49 cases of liver toxicity worldwide have been associated with the use of the dietary supplement black cohosh.
• Women Should Wait to Use Osteoporosis Drug Raloxifene (EVISTA) to Prevent Breast Cancer [hide all summaries]
  (July 2006)
  You should wait to use raloxifene for reducing the risk of breast cancer until the drug is FDA approved for this use.
• Public Citizen Asks FDA to Immediately Remove Orlistat (XENICAL) from the Market [hide all summaries]
  (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) [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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.
• Adding Clopidogrel to Aspirin Offers No Benefit in Preventing Heart Attacks or Strokes [hide all summaries]
  (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 [hide all summaries]
  (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.
• FDA Relegates ADVAIR and SEREVENT to Last Choice Status for Asthma Treatment [hide all summaries]
  (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) [hide all summaries]
  (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.
• Some Diabetes Drugs May Cause Vision Problems: Rosiglitazone (AVANDIA) and Macular Edema [hide all summaries]
  (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.
• The Diagnostic Drug Technetium 99m Tc Fanolesomab (NEUTROSPEC) is Banned [hide all summaries]
  (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.
• FDA Issues Public Health Advisory About Liver Toxicity with the Antibiotic Telithromycin (KETEK) [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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).
• A Review of Sleeping Pill Ramelteon (ROZEREM) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• Safety Alert! Meningitis Vaccine and Serious Nervous System Adverse Reactions [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• The Cholesterol-Lowering Statin Drugs and Memory Loss [hide all summaries]
  (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.
• Can a Drug Spur Pathological Gambling? Link Seen to Some Drugs Used to Treat Parkinson’s Disease [hide all summaries]
  (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)
• Vitamins: Useful or Harmful? [hide all summaries]
  (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 [hide all summaries]
  (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.
• Antibiotic Clarithromycin (BIAXIN) Can Have Deadly Interaction with Anti-Gout Drug Colchicine [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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.
• Asthma Medicines That Can Cause Asthma Attacks: SEREVENT, ADVAIR and FORADIL [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• The Dark Side of Viagra: Erectile Dysfunction Drugs And Vision Problems [hide all summaries]
  (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 [hide all summaries]
  (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? [hide all summaries]
  (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.
• Rosuvastatin (CRESTOR) - The Most Dangerous Cholesterol-Lowering Statin Drug [hide all summaries]
  (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 [hide all summaries]
  (July 2005)
  FDA relabels these drugs due to an increased risk of death among patients taking the drugs off-label for dementia.
• A Review of Eszopiclone (LUNESTA): A Not-So-New Sleeping Pill [hide all summaries]
  (July 2005)
  This drug has no unique benefits, is costly and has caused cancer in an animal study.
• Serious Skin Reactions with the Seizure Drug Oxcarbazepine (TRILEPTAL) [hide all summaries]
  (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.
• FDA Public Health Advisory - Arthritis Drug Valdecoxib (BEXTRA) Removed From Market; Major New Warnings for Other NSAIDs [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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) [hide all summaries]
  (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) [hide all summaries]
  (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) [hide all summaries]
  (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.
• Problems With COX-2 Inhibitors Vault Meloxicam (MOBIC) To Blockbuster Status [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• A Review of Ezetimibe (ZETIA) and Ezetimibe with Simvastatin (VYTORIN) For Cholesterol Lowering [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• A Review of Trospium (SANCTURA) for Overactive Bladder [hide all summaries]
  (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? [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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).
• Suicide Risk Added To The Professional Product Labeling For Eight Antidepressants [hide all summaries]
  (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 [hide all summaries]
  (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.
• A Review of New Antibiotic Telithromycin (KETEK) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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.
• The Inappropriate Prescribing of the Acne Drug Isotretinoin (ACCUTANE) Continues [hide all summaries]
  (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) [hide all summaries]
  (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.
• Further Updates on the Cholesterol-Lowering Statin Drug Rosuvastatin (CRESTOR) [hide all summaries]
  (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.
• Arthritis Drug Leflunomide (ARAVA) Linked to Japanese Deaths from Lung Disease [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• A Review of Seizure Medication Topiramate (TOPAMAX) for Weight Reduction [hide all summaries]
  (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 [hide all summaries]
  (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.
• A Review of Two More Drugs For Erectile Dysfunction: Vardenafil (LEVITRA) And Tadalifil (CIALIS) [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• Another Drug Safety Withdrawal - The Opioid Dependence Drug Levomethadyl (ORLAAM) [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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.
• Do Not Use! Rosuvastatin (Crestor) - A New But More Dangerous Cholesterol Lowering 'Statin' Drug [hide all summaries]
  (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 [hide all summaries]
  (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.
• Severe Neuropsychiatric Adverse Effects Associated With The Antimalarial Drug Mefloquine (LARIAM) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• Oxybutynin Patches (OXYTROL): A Grossly Overpriced Product For Overactive Bladder [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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.
• Do Not Use! Reports of Blood Clots With the Use of the Oral Contraceptive Drospirenone With Ethinyl Estradiol (YASMIN) [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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) [hide all summaries]
  (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.
• Important Safety Alert! Antidepressant Nefazodone (SERZONE) Withdrawn From the Market In All European Countries [hide all summaries]
  (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) [hide all summaries]
  (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 [hide all summaries]
  (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.
• Foggy Thinking as Inhaled Flu Vaccine Nears FDA Approval [hide all summaries]
  (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 [hide all summaries]
  (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
• Do Not Use! The Water Pill (diuretic) Indapamide (LOZOL) for High Blood Pressure [hide all summaries]
  (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.
• Do Not Use! New Safety Warning Added to the Arthritis Drug Valdecoxib (BEXTRA) [hide all summaries]
  (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.
• Arthritis Drug Rofecoxib (VIOXX) Linked to Increased Risk of Coronary Heart Disease [hide all summaries]
  (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.
• Drug Induced Psychiatric Symptoms (Part 2) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• Drug Induced Psychiatric Symptoms [hide all summaries]
  (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.
• Canada Bans the Dangerous Herbal Supplement Kava-Kava [hide all summaries]
  (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.
• Long Term Hormone Replacement Therapy (HRT): The Demise of a Standard of Practice [hide all summaries]
  (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 [hide all summaries]
  (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.
• New Safety Labeling Changes for Anticoagulant Warfarin (COUMADIN) [hide all summaries]
  (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.
• Comparative Gastrointestinal (GI) Toxicity of Six Nonsteroidal Anti-inflammatory Drugs (NSAIDs) [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• Public Citizen Health Research Group Publishes Companion to Worst Pills, Best Pills 1999 Edition [hide all summaries]
  (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) [hide all summaries]
  (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) [hide all summaries]
  (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 Petitions to Ban the Arthitis Drug Leflunomide (ARAVA) [hide all summaries]
  (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) [hide all summaries]
  (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.
• Public Citizen's Health Research Group's Petition to Ban Diet Drug Sibutramine (MERIDIA) [hide all summaries]
  (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.
• U.S. Consumers Finally Get Warned About Liver Toxicity with the Dietary Supplement Kava-Kava [hide all summaries]
  (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.
• FDA Strengthens Warnings for Droperidol (INAPSINE) after the Drug Was Banned in Britain [hide all summaries]
  (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) [hide all summaries]
  (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! The Pain Drug Tramadol (ULTRAM/ULTRACET) and Serotonin Syndrome [hide all summaries]
  (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! Life-threatening Liver Toxicity with the Antidepressant Nefazadone (SERZONE) [hide all summaries]
  (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 [hide all summaries]
  (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.
• Canadians Begin Recall of Dangerous Drug Supplement Ephedra [hide all summaries]
  (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.
• Do Not Use! The Flu Drug Zanamivir (RELENZA) Revisited [hide all summaries]
  (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 [hide all summaries]
  (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 [hide all summaries]
  (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.
• Do Not Use. Europeans Strengthen Liver Toxicity Warnings on the Arthritis Drug Leflunomide (ARAVA) [hide all summaries]
  (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.
• Two New Warnings! Tuberculosis and Heart Failure with Infliximab (REMICADE) [hide all summaries]
  (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 [hide all summaries]
  (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.
• Drugs for Possible Exposure to Anthrax: What Makes Sense? [hide all summaries]
  (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.
• Serious Vision Disorder With Topiramate (TOPAMAX) [hide all summaries]
  (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.
• New Safety Warning For the Alzheimer’s Disease Drug Rivastigmine (EXELON) [hide all summaries]
  (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.
• Irritable Bowel Syndrome (IBS) Drug Alosetron (LOTRONEX) Withdrawn From the Market [hide all summaries]
  (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.

• benzphetamine (DIDREX); diethylpropion (TENUATE, TEPANIL); phendimetrazine (PLEGINE); phentermine (ADIPEX-P, FASTIN)
• orlistat (ALLI, XENICAL)
• sibutramine (MERIDIA)
• levonorgestrel and ethinyl estradiol [oral contraceptive] (ALESSE 28, AVIANE, NORDETTE, SEASONALE, TRIPHASIL, TRIVORA-28); norethindrone and ethinyl estradiol (COMBI PATCH, LOESTRIN FE 1/20, NEOCON 1/35, ORTHO-NOVUM 7/7/7, OVCON 35); norgestimate and ethinyl estradiol (ORTHO-CYCLEN, ORTHOTRI-CYCLEN, TRINESSA); norgestrel and ethinyl estradiol (LO/OVRAL 28, LOW-OGESTREL)
• desogestrel and ethinyl estradiol (DESOGEN, MIRCETTE, ORTHO-CEPT)
• drospirenone and ethinyl estradiol (YASMIN)
• dextroamphetamine (DEXEDRINE); various amphetamines (ADDERALL, ADDERALL XR)
• atomoxetine (STRATTERA)
• dexmethylphenidate (FOCALIN, FOCALIN XR)
• methylphenidate [extended release] (CONCERTA, DAYTRANA [TRANSDERMAL], METADATE CD, METADATE ER, METHYLIN ER, RITALIN LA); methylphenidate [immediate release] (METHYLIN, RITALIN); methylphenidate [sustained release] (RITALIN-SR)
• pemoline (CYLERT)
• conjugated estrogens (PREMARIN); estradiol [patch] (CLIMARA); synthetic conjugated estrogens (CENESTIN)
• progesterone (PROMETRIUM)
• tamoxifen (NOLVADEX)
• conjugated estrogens with medroxyprogesterone (PREMPHASE, PREMPRO); ethinyl estradiol with norethindrone (FEMHRT)
• esterified estrogens with methyltestosterone (ESTRATEST, ESTRATEST HS)
• acetohexamide (DYMELOR); chlorpropamide (DIABINESE)
• glimepiride (AMARYL); glipizide (GLUCOTROL); glyburide (DIABETA, GLYNASE, MICRONASE); tolazamide (TOLINASE); tolbutamide (ORINASE)
• glargine insulin (LANTUS); human insulin (HUMULIN, ILETIN, INSULATARD, MIXTARD, NOVOLIN, VELOSULIN); lispro insulin (HUMALOG)
• pioglitazone (ACTOS); rosiglitazone (AVANDIA)
• metformin (GLUCOPHAGE)
• nateglinide (STARLIX); repaglinide (PRANDIN)
• alfuzosin (UROXATRAL); doxazosin [prostate] (CARDURA [PROSTATE]); tamsulosin (FLOMAX); terazosin [prostate] (HYTRIN [PROSTATE])
• finasteride (PROSCAR)
• almotriptan (AXERT); eletriptan (RELPAX); frovatriptan (FROVA); naratriptan (AMERGE); rizatriptan (MAXALT, MAXALT MLT); sumatriptan (IMITREX); zolmitriptan (ZOMIG, ZOMIG ZMT)
• citalopram (CELEXA); fluoxetine (PROZAC, SERAFEM); fluvoxamine (LUVOX); paroxetine (PAXIL, PEXEVA); sertraline (ZOLOFT)
• amoxapine (ASENDIN); doxepin (SINEQUAN); imipramine (TOFRANIL, TOFRANIL PM)
• carisoprodol (SOMA); carisoprodol with aspirin (SOMA COMPOUND); carisoprodol, aspirin and codeine (SOMA COMPOUND WITH CODEINE)
• chlorzoxazone (PARAFON FORTE DSC)
• cyclobenzaprine (FLEXERIL)
• methocarbamol (ROBAXIN)
• orphenadrine (NORFLEX); orphenadrine, aspirin and caffeine (NORGESIC FORTE)
• bupropion [smoking] (ZYBAN)
• desipramine (NORPRAMIN); nortriptyline (AVENTYL, PAMELOR)
• amitriptyline (ELAVIL)
• amitriptyline and chlordiazepoxide (LIMBITROL)
• amitriptyline and perphenazine (TRIAVIL)
• bupropion [mind] (WELLBUTRIN)
• alendronate (FOSAMAX); risedronate (ACTONEL)
• raloxifene (EVISTA)
• calcitonin [calcitonin-salmon] (MIACALCIN)
• teriparatide (FORTEO)
• thioridazine (MELLARIL)
• thiothixene (NAVANE)
• maprotiline (LUDIOMIL)
• chlorpromazine (THORAZINE); fluphenazine (PROLIXIN); trifluoperazine (STELAZINE)
• lithium (ESKALITH, LITHOBID, LITHONATE)
• mirtazapine (REMERON)
• nefazodone (SERZONE)
• trazodone (DESYREL)
• venlafaxine (EFFEXOR, EFFEXOR XR)
• clozapine (CLOZARIL, FAZACLO ODT)
• olanzapine (ZYPREXA)
• alprazolam (XANAX); chlordiazepoxide (LIBRIUM); clorazepate (TRANXENE); diazepam (VALIUM); estazolam (PROSOM); flurazepam (DALMANE); halazepam (PAXIPAM); lorazepam (ATIVAN); prazepam (CENTRAX); quazepam (DORAL); temazepam (RESTORIL); triazolam (HALCION)
• quetiapine (SEROQUEL)
• risperidone (RISPERDAL)
• ziprasidone (GEODON, ZELDOX)
• oxazepam (SERAX)
• zolpidem (AMBIEN)
• haloperidol (HALDOL)
• mesoridazine (SERENTIL (DISCONTINUED))
• buspirone (BUSPAR)
• meprobamate (EQUANIL, MILTOWN)
• aripiprazole (ABILIFY)
• acetazolamide (DIAMOX); methazolamide (NEPTAZANE)
• betaxolol - eye (BETOPTIC, BETOPTIC S); levobunolol (BETAGAN); timolol [eye drops] (TIMOPTIC)
• brimonidine (ALPHAGAN)
• dorzolamide (TRUSOPT); dorzolamide and timolol (COSOPT)
• latanoprost (XALATAN)
• pilocarpine (ADSORBOCARPINE, ISOPTO CARPINE)
• sulfacetamide (SULAMYD)
• sulfacetamide and prednisolone (BLEPHAMIDE, VASOCIDIN)
• moxifloxacin [eye drops] (VIGAMOX); ofloxacin [eye] (OCUFLOX)
• fluorometholone (FML)
• neomycin and dexamethasone (NEODECADRON); neomycin p, polymyxin b, and dexamethasone (MAXITROL)
• olopatadine (PATANOL)
• oxybutynin (DITROPAN, DITROPAN XL, OXYTROL TRANSDERMAL SYSTEM); tolterodine (DETROL, DETROL LA)
• phenazopyridine (PYRIDIUM)
• dexamethasone (DECADRON, HEXADROL, MYMETHASONE); hydrocortisone [oral] (CORTEF, HYDROCORTONE); methylprednisolone (MEDROL); prednisolone (PRELONE); prednisone (DELTASONE)
• ibuprofen (ADVIL, MEDIPREN, MOTRIN, NUPRIN)
• diclofenac (VOLTAREN); etodolac (LODINE); fenoprofen (NALFON); flurbiprofen (ANSAID, OCUFEN); ketoprofen (ORUDIS); meclofenamate (MECLOMEN); mefenamic acid (PONSTEL); nabumetone (RELAFEN); naproxen (ALEVE, ANAPROX, NAPROSYN); oxaprozin (DAYPRO); sulindac (CLINORIL); tolmetin (TOLECTIN)
• indomethacin (INDOCIN)
• ketorolac (TORADOL)
• piroxicam (FELDENE)
• celecoxib (CELEBREX); meloxicam (MOBIC); rofecoxib (VIOXX); valdecoxib (BEXTRA)
• aspirin (EASPRIN, ECOTRIN, EMPIRIN, GENUINE BAYER ASPIRIN)
• buffered aspirin (ASCRIPTIN, BUFFERIN); diflunisal (DOLOBID); salsalate (DISALCID)
• acetaminophen (TYLENOL)
• acetaminophen and codeine (APAP, TYLENOL WITH CODEINE); acetaminophen and hydrocodone (BANCAP-HC, LORTAB, VICODIN); acetaminophen and oxycodone (PERCOCET, ROXICET, TYLOX); aspirin and oxycodone (PERCODAN); codeine; hydrocodone and ibuprofen (VICOPROFEN); hydromorphone (DILAUDID); meperidine (DEMEROL); morphine (AVINZA, KADIAN, MS CONTIN); oxycodone (OXYCONTIN)
• fentanyl [patch] (DURAGESIC)
• methadone (DOLOPHINE, METHADOSE)
• donepezil (ARICEPT); tacrine (COGNEX)
• galantamine (RAZADYNE, RAZADYNE ER, REMINYL); rivastigmine (EXELON)
• memantine (NAMENDA)
• butorphanol (STADOL)
• pentazocine (TALWIN); pentazocine and naloxone (TALWIN-NX)
• propoxyphene (DARVON, DARVON-N); propoxyphene and acetaminophen (DARVOCET-N, PROPOXACET-N, WYGESIC); propoxyphene, aspirin and caffeine (DARVON COMPOUND, DARVON COMPOUND-65)
• tramadol (ULTRAM); tramadol and acetaminophen (ULTRACET)
• butalbital, acetaminophen and caffeine (ESGIC PLUS, FIORICET); butalbital, caffeine and aspirin (FIORINAL); butalbital, caffeine, aspirin and codeine (FIORINAL WITH CODEINE)
• adalimumab (HUMIRA); anakinra (KINERET); etanercept (ENBREL); infliximab (REMICADE)
• allopurinol (ZYLOPRIM)
• azathioprine (IMURAN)
• colchicine
• benztropine (COGENTIN); trihexyphenidyl (ARTANE)
• bromocriptine (PARLODEL)
• entacapone (COMTAN); entacapone with levodopa and carbidopa (STALEVO)
• tolcapone (TASMAR)
• clonazepam (KLONOPIN)
• divalproex (DEPAKENE/DEPAKOTE); valproic acid (DEPAKENE)
• phenobarbital (LUMINAL, SOLFOTON)
• phenytoin (DILANTIN)
• tizanidine (ZANAFLEX)
• hydroxychloroquine (PLAQUENIL)
• leflunomide (ARAVA)
• methotrexate (TREXALL)
• probenecid (PROBALAN)
• vitamin A [retinol] (AQUASOL A)
• niacin [vitamin B3] (NICOLAR)
• vitamin D (CALCIFEROL)
• vitamin E [alpha tocopherol]
• chlorothiazide (DIURIL); chlorthalidone (HYGROTON); hydrochlorothiazide (ESIDRIX, HYDRODIURIL, MICROZIDE); methyclothiazide (ENDURON); metolazone (DIULO, ZAROXOLYN); polythiazide (RENESE)
• indapamide (LOZOL)
• bumetanide (BUMEX); furosemide (LASIX)
• amiloride and hydrochlorothiazide (MODURETIC)
• eplerenone (INSPRA)
• spironolactone (ALDACTONE)
• spironolactone and hydrochlorothiazide (ALDACTAZIDE)
• triamterene (DYRENIUM)
• triamterene and hydrochlorothiazide (DYAZIDE, MAXZIDE)
• candesartan (ATACAND); candesartan and hydrochlorothiazide (ATACAND HCT); eprosartan (TEVETEN); irbesartan (AVAPRO); irbesartan and hydrochlorothiazide (AVALIDE); losartan (COZAAR); losartan and hydrochlorothiazide (HYZAAR); olmesartan (BENICAR); olmesartan and hydrochlorothiazide (BENICAR HCT); telmisartan (MICARDIS); telmisartan and hydrochlorothiazide (MICARDIS HCT); valsartan (DIOVAN); valsartan and hydrochlorothiazide (DIOVAN HCT)
• acebutolol (SECTRAL); atenolol (TENORMIN); atenolol and chlorthalidone (TENORETIC); betaxolol - heart (KERLONE); bisoprolol (ZEBETA); bisoprolol and hydrochlorothiazide (ZIAC); carvedilol (COREG); labetalol (NORMODYNE, TRANDATE); metoprolol (LOPRESSOR, TOPROL XL); metoprolol and hydrochlorothiazide (LOPRESSOR HCT); nadolol (CORGARD); penbutolol (LEVATOL); pindolol (VISKEN); propranolol (INDERAL, INDERAL LA); propranolol and hydrochlorothiazide (INDERIDE LA); timolol [heart] (BLOCADREN); timolol and hydrochlorothiazide (TIMOLIDE)
• benazepril (ETHEX, LOTENSIN); benazepril and hydrochlorothiazide (LOTENSIN HCT); captopril (CAPOTEN); captopril and hydrochlorothiazide (CAPOZIDE); enalapril (VASOTEC); enalapril and hydrochlorothiazide (VASERETIC); fosinopril (MONOPRIL); lisinopril (PRINIVIL, ZESTRIL); lisinopril and hydrochlorothiazide (PRINZIDE, ZESTORETIC); moexipril (UNIVASC); perindopril (ACEON); quinapril (ACCUPRIL); ramipril (ALTACE); trandolapril (MAVIK)
• amlodipine (NORVASC); diltiazem (CARDIZEM, CARDIZEM CD, DILACOR XR, TIAZAC); felodipine (PLENDIL); isradipine (DYNACIRC, DYNACIRC CR); nicardipine (CARDENE, CARDENE SR); nifedipine (ADALAT CC, PROCARDIA XL); nisoldipine (SULAR); verapamil (CALAN, CALAN SR, COVERA-HS, ISOPTIN, ISOPTIN SR, VERELAN)
• hydralazine (APRESOLINE); hydralazine and hydrochlorothiazide (APRESOLINE ESIDREX)
• clonidine (CATAPRES); clonidine and chlorthalidone (COMBIPRES); clonidine transdermal therapeutic system (CATAPRES-TTS)
• gemfibrozil (LOPID)
• fenofibrate (TRICOR)
• azelastine (ASTELIN)
• fluvastatin (LESCOL, LESCOL XL)
• atorvastatin (LIPITOR); lovastatin (MEVACOR); lovastatin extended release (ALTOCOR); pravastatin (PRAVACHOL); simvastatin (ZOCOR)
• rosuvastatin (CRESTOR)
• niacin extended [intermediate] release (NIASPAN)
• ezetimibe (ZETIA)
• cetirizine (ZYRTEC); hydroxyzine (ATARAX, HY-PAM, VISTARIL)
• chlorpheniramine (ALERMINE, CHLOR-TRIMETON); chlorpheniramine injection; diphenhydramine (BENADRYL, DYTAN SUSPENSION, DYTAN-D SUSPENSION, SOMINEX FORMULA); diphenhydramine injection
• cholestyramine (LOCHOLEST, QUESTRAN, QUESTRAN LIGHT)
• cyproheptadine (PERIACTIN)
• desloratadine (CLARINEX)
• fexofenadine (ALLEGRA); loratadine (CLARITIN)
• disopyramide (NORPACE)
• pseudoephedrine (SUDAFED)
• dextromethorphan (DELSYM)
• procainamide (PROCANBID)
• mexiletine (MEXITIL)
• amiodarone (CORDARONE, PACERONE)
• quinidine (DURAQUIN, QUINAGLUTE DURA-TABS, QUINIDEX)
• digoxin (DIGITEK, LANOXICAPS, LANOXIN)
• pentoxifylline (TRENTAL)
• warfarin (COUMADIN)
• clopidogrel (PLAVIX)
• ticlopidine (TICLID)
• extended release potassium supplements (K-DUR, K-TABS); potassium supplements (K-LOR, KAOCHLOR, KAON-CL, KATO, KAY/CIEL, KLOTRIX, MICRO-K, SLOW-K)
• benzonatate (TESSALON)
• hydrocodone and homatropine (HYCODAN)
• beclomethasone nasal steroid spray (BECLOVENT, BECONASE AQ, VANCENASE AQ, VANCERIL); budesonide (RHINOCORT AQUA); fluticasone nasal steroid spray (FLONASE); mometasone nasal steroid spray (NASONEX); triamcinolone nasal steroid spray (NASACORT AQ)
• albuterol (PROVENTIL, VENTOLIN); pirbuterol (MAXAIR)
• fluticasone and salmeterol inhalation powders (ADVAIR DISKUS)
• salmeterol (SEREVENT)
• isoetharine (BETA-2, BRONKOMETER, BRONKOSOL)
• aluminum hydroxide (AMPHOJEL); aluminum hydroxide and magnesium carbonate (GAVISCON, GAVISCON-2); aluminum hydroxide and magnesium hydroxide (MAALOX, MAALOX TC); magaldrate (RIOPAN); magnesium hydroxide (FAMILY DOLLAR MILK OF MAGNESIA, PHILLIPS’ MILK OF MAGNESIA)
• aminophylline (AMOLINE, SOMOPHYLLIN, SOMOPHYLLIN-DF); theophylline (BRONKODYL, CONSTANT-T, ELIXOPHYLLIN, QUIBRON-T-SR, SLO-BID, SLO-PHYLLIN, SOMOPHYLLIN-CRT, SOMOPHYLLIN-T, SUSTAIRE, THEO-24, THEO-DUR, THEOLAIR, THEOLAIR-SR, UNIPHYL)
• cimetidine (TAGAMET); famotidine (PEPCID); nizatidine (AXID); ranitidine (ZANTAC)
• oxtriphylline (CHOLEDYL SA)
• beclomethasone inhaled steroid (QVAR AEROSOL); fluticasone inhaled steroid (FLOVENT, FLOVENT DISKUS, FLOVENT ROTADISK); triamcinolone inhalation (AZMACORT AEROSOL CANISTER)
• montelukast (SINGULAIR); zafirlukast (ACCOLATE)
• ipratropium (ATROVENT); ipratropium and albuterol (COMBIVENT)
• amoxicillin (AMOXIL); amoxicillin and clavulanate (AUGMENTIN); ampicillin (OMNIPEN)
• misoprostol (CYTOTEC)
• penicillin g; penicillin v (PEN VEE K)
• cefaclor (CECLOR); cefadroxil (DURICEF); cefditoren (SPECTRACEF); cefixime (SUPRAX); cefpodoxime (VANTIN); cefprozil (CEFZIL); cefuroxime axetil (CEFTIN); cephalexin (KEFLEX); cephradine (VELOSEF); loracarbef (LORABID)
• sucralfate (CARAFATE)
• erythromycin (EES, ERYTHROCIN)
• azithromycin (ZITHROMAX); clarithromycin (BIAXIN)
• erythromycin estolate (ILOSONE)
• telithromycin (KETEK)
• doxycycline (VIBRAMYCIN); minocycline (MINOCIN); tetracycline (ACHROMYCIN, PANMYCIN)
• sulfisoxazole (GANTRISIN); trimethoprim and sulfamethoxazole (BACTRIM, COTRIM, SEPTRA)
• gatifloxacin (TEQUIN); moxifloxacin (AVELOX); sparfloxacin (ZAGAM)
• alosetron (LOTRONEX)
• ciprofloxacin (CILOXAN, CIPRO); levofloxacin (LEVAQUIN); lomefloxacin (MAXAQUIN); ofloxacin (FLOXIN)
• norfloxacin (CHIBROXIN, NOROXIN)
• tegaserod (ZELNORM)
• trovafloxacin (TROVAN)
• prochlorperazine (COMPAZINE); promethazine (PHENERGAN)
• gemifloxacin (FACTIVE)
• trimethoprim (PROLOPRIM, TRIMPEX)
• clindamycin (CLEOCIN)
• metronidazole (FLAGYL)
• nitrofurantoin (FURADANTIN, MACROBID, MACRODANTIN)
• metoclopramide (REGLAN)
• trimethobenzamide (TIGAN)
• atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate and benzoic acid (URISED)
• chloramphenicol (CHLOROMYCETIN)
• isoniazid (INH)
• rifampin (RIFADIN, RIMACTANE)
• fluconazole (DIFLUCAN)
• itraconazole (SPORANOX); terbinafine (LAMISIL)
• terconazole (TERAZOL 3, TERAZOL 7)
• mebendazole (VERMOX)
• lindane (KWELL)
• amantadine (SYMMETREL)
• zanamivir (RELENZA)
• black cohosh (AWARENESS FEMALE BALANCE, ESTROVEN, REMIFEMIN)
• coenzyme q10 [co q 10, q10, vitamin q10, ubiquinone, ubidecarenone] (ANTI-AGING DAILY PREMIUM PAK, Q-GEL, VITAMIST INTRA-ORAL SPRAY)
• echinacea [purple coneflower, red sunflower, thimbleweed, rudbeckia] (HALLS DEFENSE MULTI-BLEND SUPPLEMENT DROPS)
• ephedra [ma huang, chinese ephedra, epitonin]
• garlic (KWAI, PHYTO-VITE)
• ginkgo biloba [maidenhair, EGb 761] (BIOLEAN FREE, CONCENTRATION, NEURO-BETIC, POWER CIRCULATION, SATIETE, STEPHAN CLARITY, STEPHAN ELIXIR, SUN-CARDO)
• ginseng (5 SENG TEA, DEXATRIM RESULTS, DIABETAN, GEROMATRIX GLUCOSE BALANCE, JIANG TANG PIAN, NATURE'S PLUS THE ENERGY SUPPLEMENTS, ONE-A-DAY ACTIVE DIETARY SUPPLEMENT, ONE-A-DAY ENERGY FORMULA, PHARMATON, POWER FRESH, UP YOUR GAS ENERGY BOOSTER)
• glucosamine and chondroitin (DONA, MAJESTIC EARTH)
• green tea
• milk thistle (MILK THISTLE HEALTH LIVER, RELIVE, THISILYN)
• saw palmetto [serenoa repens; serenoa serrulata; sabal serrulata] (ONE-A-DAY PROSTATE HEALTH, PERMIXON, POWER LASTING)
• St. John's wort [hypericum, goatweed, the lord god's wonder plant, witch's herb] (SUN BEAUTY)
• methylcellulose (CITRUCEL); psyllium (METAMUCIL, PERDIEM)
• lactulose (CEPHULAC, CHRONOLAC)
• bisacodyl (DULCOLAX); docusate (COLACE, SURFAK); docusate and casanthranol (DIALOSE PLUS, PERI-COLACE)
• loperamide (IMODIUM)
• diphenoxylate and atropine (LOMOTIL)
• atropine; atropine, hyoscyamine, scopolamine, and phenobarbital (DONNATAL); dicyclomine (BENTYL); hyoscyamine (LEVBID, LEVSIN)
• chlordiazepoxide and clidinium (LIBRAX)
• oseltamivir (TAMIFLU)
• pregabalin (LYRICA)