Worst Pills, Best Pills

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

diabetes mellitus, type 2


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DISEASE AND DRUG FAMILY INFORMATION
Diabetes Prevention and Treatment
Diets that are very complicated or very different from what you are used to are hard to follow. The American Diabetes Association (ADA) diet is a highly structured plan based on exchange lists. Although it serves its purpose of regulating calorie and sugar intake quite well, the ADA diet may be difficult for older people to use. Successful use of this diet requires considerable time spent planning meal patterns and food portions. Older people often have trouble with this diet because the food lists are long and complicated and require considerable memorization.

DRUG AND DIETARY SUPPLEMENT PROFILES

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

acetohexamide (DYMELOR); chlorpropamide (DIABINESE, GLUCAMIDE)
  • We list these drugs as Do Not Use drugs because they are more likely than similar drugs for diabetes to cause low blood sugar.
nateglinide (STARLIX); repaglinide (PRANDIN)
  • We list these related drugs as Do Not Use drugs because one of them is less effective than other drugs available for diabetes.
pioglitazone (ACTOS); rosiglitazone (AVANDIA)
  • We list these drugs as Do Not Use drugs because they may be less effective than other drugs for diabetes and cause liver damage, weight gain, anemia and heart failure.

WORST PILLS, BEST PILLS NEWSLETTER ARTICLES
Important Drug Interactions for the Type 2 Diabetes Drug Metformin
March 2024
Metformin is a recommended first-line treatment for patients with type 2 diabetes who are not able to control their blood sugar through diet and exercise alone. Metformin, however, has important drug interactions and can cause a serious condition called lactic acidosis, a buildup of lactic acid in the blood. Learn about metformin’s drug interactions.
Drugs Associated with Osteoporosis and Related Fractures
January 2024
Osteoporosis occurs when there is a decrease in bone mineral density and bone quality that can weaken bones, making them susceptible to fracture easily. Learn about drugs that are associated with osteoporosis and related fractures.
Tirzepatide (MOUNJARO): Another Diabetes Drug Seeking FDA Approval for Weight Loss
October 2023
In 2022, the FDA approved tirzepatide (MOUNJARO) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Learn about the evidence for the use of tirzepatide for diabetes and chronic weight management. As of mid-September 2023, the FDA had not approved tirzepatide for chronic weight management.
Semaglutide (WEGOVY) for Weight Loss: Substantial Risks, Including Weight Regain
August 2023
Semaglutide, an injectable glucagon-like peptide-1 agonist, is having its moment as a drug for weight loss. Learn about the substantial risks of semaglutide, including weight regain if the medication is stopped.
Liraglutide (SAXENDA): A Bad Weight-Loss Choice at Any Age
June 2023
Public Citizen’s Health Research Group has designated the chronic weight-management drug liraglutide (SAXENDA) as Do Not Use for all age groups. This article discusses the lack of strong evidence showing long-term, lasting and clinically meaningful benefits that outweigh the drug’s risks, both in obese adolescents and adults.
Concentrated Insulin Glargine, TOUJEO: Limited Use for Diabetes
April 2023
As seven years have passed since Toujeo’s approval without new major safety concerns being identified, Public Citizen’s Health Research Group has now designated it as Limited Use — a treatment for diabetes that should be used only if treatment with less concentrated and cheaper forms of insulin have first been tried and found to be inadequate.
“Do Not Use” Type 2 Diabetes Gliptin Drugs Also Raise Risk of Gallbladder Inflammation
March 2023
A recent study showed that, compared with other diabetes drugs, gliptins (or dipeptidyl peptidase 4 [DPP-4] inhibitors) put patients at a higher relative risk of a range of gallbladder or biliary diseases, such as gallstones (cholelithiasis) and gallbladder inflammation (cholecystitis).
Lifesaving Insulin Remains Unaffordable for Too Many U.S. Patients
February 2023
In his editor’s column, Dr. Carome discusses the implications of new research documenting the extent of insulin rationing by diabetes patients in the United States due to Big Pharma’s relentless price gouging.
Drug-Induced Gallstones (Cholelithiasis)
June 2022
Learn about several drugs that can promote the formation of gallstones — stones in the gallbladder (a condition known as cholelithiasis) — and what you can do about it.
Magnesium Is Best Obtained From Dietary Sources, Not Supplements
February 2022
It is estimated that more than a quarter of adult Americans take a magnesium supplement. However, preference should be given to relying on dietary sources of this critical mineral whenever possible to avoid adverse effects.
10 Rules for Safer Drug Use
November 2021
Patients often wonder what steps they can take to minimize their chances of suffering a serious adverse drug reaction. This article reviews 10 simple rules developed by Public Citizen’s Health Research Group for ensuring safer drug use.
Important Drug Interactions for the Antifungal Drug Itraconazole
November 2021
Patients taking the oral antifungal drug itraconazole (SPORANOX, TOLSURA) should be aware that it has clinically important interactions with many other prescription medications that can affect the safety or effectiveness of itraconazole or the interacting drugs.
Important Drug Interactions for the Hypertension and Angina Drug Nifedipine
August 2021
Patients taking the widely prescribed calcium channel blocker nifedipine (PROCARDIA, PROCARDIA XL) should be aware that it has clinically important interactions with many other prescription medications.
Quitting Smoking: Behavioral Therapy and Medications Can Help
August 2021
In this article, we discuss the most recent smoking-cessation recommendations from the U.S. Preventive Services Task Force and the underlying research supporting these recommendations.
Public Citizen Calls on FDA to Require Black-Box Warning for Newest Diabetes Drugs
October 2020
Learn why patients with type 1 diabetes should never use any of the type 2 diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, which are often referred to as “flozins” or “gliflozins.”
Important Drug Interactions for the Anticoagulant Warfarin
August 2020
Patients taking the commonly used blood thinner warfarin (COUMADIN, JANTOVEN) should be aware that it has clinically important interactions with numerous other prescription and over-the-counter medications, as well as some dietary supplements.
New Research Shows Vitamin D Supplements Not Useful for Preventing Cancer, Cardiovascular Disease or Diabetes
December 2019
Learn about results of two large, well-designed, randomized clinical trials funded by the National Institutes of Health demonstrating that high-dose vitamin D supplementation was not useful for preventing cancer, cardiovascular disease or diabetes.
Reckless Failure to Identify Dangerous Adverse Effect of New Diabetes Drugs
December 2019
In his editor’s column, Dr. Michael Carome discusses the failure of drug companies, researchers and the FDA to recognize the overwhelming evidence dating back to the early 1900s demonstrating that the new diabetes drugs known as “flozins” can cause life-threatening ketoacidosis.
Numerous Drugs Have Dangerous Interactions with Alcohol
August 2019
Most U.S. adults drink alcohol at least occasionally. Many also take prescription or over-the-counter drugs that have the potential to inter¬act adversely with alcohol. Avoid serious harm by knowing which drugs should not be taken in combination with alcohol.
Pharma's Price Gouging on Insulin Is Literally Killing Patients
April 2019
Many diabetes patients, including some with health insurance, can no longer afford to take the dosage of life-saving insulin prescribed by their doctors because of price gouging by the pharmaceutical industry. For some of these patients, the rationing of unaffordable insulin has proved to be fatal.
Question & Answer
January 2019
In response to a reader’s question about our article “Metformin: First-Choice Drug for Type 2 Diabetes” in the August 2018 issue, we discuss the risk of diarrhea and other adverse gastrointestinal effects that may occur when taking metformin.
FDA Warns About Serious Genital Infections With Newest Class of Diabetes Drugs
January 2019
Learn about a rare but potentially fatal bacterial infection in the area of the genitals that has been linked to the diabetes drugs known as sodium-glucose cotransporter-2 inhibitors, commonly called “flozins.”
Our Assessments of Medications Sometimes Change Over Time
December 2018
In his editor’s column, Dr. Michael Carome, prompted by a recent letter from one of our readers, discusses why our recommendations and designations for specific drugs sometimes change based on new information.
Metformin: First-Choice Drug for Type 2 Diabetes
August 2018
Learn why metformin is the drug of choice for the initial treatment of patients with type 2 diabetes who are not able to control their blood sugar through diet and exercise alone and who do not have severe kidney impairment.
10 Rules for Safer Drug Use
March 2018
Patients often wonder what steps they can take to minimize their chances of suffering a serious adverse drug reaction. This article reviews 10 simple rules developed by Public Citizen’s Health Research Group for ensuring safer drug use.
The Dangerous Diabetes Drug Pramlintide: Do Not Use
December 2017
In this article, we explain why the serious adverse effects of the injected diabetes drug pramlintide far outweigh the drug’s limited benefits.
Diabetes Drug Canagliflozin Doubles Risk of Amputations, FDA Warns
October 2017
Canagliflozin is one of three medications in the newest diabetes drug class. In this article, we discuss why the FDA recently required that a black-box warning about the risk of amputations be added to the product labeling of canagliflozin.
Drugs That Are Most Likely to Land Patients in the Emergency Room
June 2017
Many adverse drug reactions are severe enough to cause serious injury, hospitalization and even death. Find out which outpatient medications are most likely to cause adverse events that necessitate a visit to the emergency room.
Benefits of Probiotics Remain Unproven
June 2017
The food and dietary supplement industries have been swift to capitalize on the excitement surrounding the microbes living on or within our bodies by selling products that contain probiotics, or live microor¬ganisms purported to improve health by altering the microbiome. In this article, we explain which claims about probiotics have been tested in clinical trials — and why many probiotic supplements are very likely a waste of money.
Drugs That Increase the Risk of Falling
January 2017
Falls remain by far the leading cause of injuries among adults age 65 and older in the U.S. In this article, we identify many of the drugs that can increase your risk of falling and offer advice on how to protect yourself from fall-related injuries.
Insulin Glargine (TOUJEO): Do Not Use for Seven Years
November 2016
TOUJEO is a newer, long-acting, once-daily insulin approved by the Food and Drug Administration for the treatment of Type 1 and Type 2 diabetes in adults. Learn why you should avoid using this drug until at least 2022.
FDA Issues Multiple Warnings For Newest Class of Diabetes Drugs
October 2016
Over the past year, the Food and Drug Administration has issued a series of new warnings about serious and, in some cases, potentially fatal events linked to the newest class of diabetes drugs. These drugs, known as "flozins," are being heavily promoted in TV ads. Learn more about these newly identified dangers and why you should avoid all flozins.
News Brief for August 2016
August 2016
In this month's news briefs, we report on the FDA's decision to require new black-box warnings in the labeling of all immediate-release opioid drugs about the risks of abuse, addiction, overdose and death, as well as the agency's recent drug safety alert reminding consumers not to purchase over-the-counter chelation products. We also discuss the decision of a major drugmaker to terminate its involvement in the marketing of an inhaled form of insulin.
Incretin-Mimetic Drugs: Do Not Use to Treat Diabetes
August 2016
Incretin mimetics, one of the newer classes of diabetes drugs, are widely prescribed in the U.S. Find out why Public Citizen's Health Research Group recommends against using any of these medications.
News Brief for February 2016
February 2016
In our news brief this month, we report on two recent warnings issued by the Food and Drug Administration about the diabetes drugs known as SGLT2 inhibitors, more commonly known as “flozins.” This family of drugs, all designated as Do Not Use, includes canagliflozin (INVOKAMET, INVOKANA), dapagliflozin (FARXIGA) and empagliflozin (JARDIANCE).
Health Canada Warns of Dangerous Drug Interaction
January 2016
Learn why Health Canada, an agency similar to the Food and Drug Administration, warned Canadian consumers not to combine repaglinide-containing diabetes medications (PRANDIN or PRANDIMET) with the anti-platelet drug clopidogrel (PLAVIX).
Inhaled Insulin AFREZZA Ineffective, Can Damage Lungs
December 2015
Find out why this new form of insulin, which is inhaled as a powder, is a dangerous alternative to injected forms of insulin and never should have been approved by the Food and Drug Administration for the treatment of diabetes.
Risks but No Benefits to Taking Newest Drugs For Type 2 Diabetes
August 2015
The airwaves are filled with ads promoting the newest class of diabetes medications, often referred to as “flozins.” In this article, we review the serious safety concerns that have prompted us to designate all flozins as Do Not Use.
Public Citizen Shines a Light on Off-Label Promotion of Diabetes Drugs
July 2015
In a recent complaint to the FDA, we took several makers of diabetes drugs to task for direct-to-consumer ads that promote the drugs for unapproved uses. Find out the names of the drugs targeted in our complaint and the nature of the off-label uses being promoted in the ads.
New Study Reveals Many Patients at Risk for Dangerous Alcohol-Drug Interactions
July 2015
Recent research revealed that many patients consume alcohol while using drugs that may can cause dangerous side effects when combined with alcohol. Read this article to learn about the many ways alcohol can adversely interact with prescription and over-the-counter medications.
Albiglutide (TANZEUM): Another Me-Too Drug for Type 2 Diabetes
December 2014
Read about the dangers posed by albiglutide, yet another new diabetes drug designated as Do Not Use by Public Citizen’s Health Research Group because it offers no unique benefits but does pose unique risks.
Combining Diabetes Drugs With Certain Antibiotics May Cause Dangerous Drops in Blood Sugar Levels
November 2014
Serious adverse reactions often occur when different drugs are taken together. Find out which antibiotics diabetic patients taking glipizide (GLUCOTROL, GLUCOTROL XL) or glyburide (DIABETA, GLUCOVANCE, GLYNASE) should avoid because of an increased risk of life-threatening drops in blood sugar levels.
New Diabetes Drug Dapagliflozin (FARXIGA): Risks Outweigh Benefits
September 2014
Learn about the many dangers of one of the newest diabetes drugs approved in the U.S., dapagliflozin, which has been designated as Do Not Use by Public Citizen’s Health Research Group.
Type 2 Diabetes Drug Alogliptin Causes Liver Toxicity
August 2014
Learn why Public Citizen’s Health Research Group has designated the following three new Type 2 diabetes drugs as Do Not Use: alogliptin (NESINA), the combination of alogliptin and metformin (KAZANO), and the combination of alogliptin and pioglitazone (OSENI).
Type 2 Diabetes: A Guide to Prevention and Treatment
May 2014
The treatment options for Type 2 diabetes can be overwhelming. This article provides a comprehensive summary of our independent expert views on the best approaches for preventing and treating this common disease.
Year in Review: Troubling New Drug Approvals of 2013
March 2014
Learn about new drugs approved by the FDA in 2013 that Worst Pills Best Pills has identified as dangerous or ineffective. The drugs include two for diabetes, two for chronic obstructive pulmonary disease and an over-the-counter drug for overactive bladder, among others.
The New Diabetes Drug Canagliflozin (INVOKANA)
February 2014
Do not use the newly approved diabetes drug INVOKANA. It offers no benefits over existing drugs but can result in serious risks, including hypotension and impaired kidney function, outlined in the article.
FDA Moves to Loosen Restrictions on Diabetes Drug Avandia
September 2013
The FDA is considering relaxing the restrictions on the unacceptably dangerous drug rosiglitazone (AVANDIA) so that more people can access it, even while it remains banned in European countries.
Diabetes Drugs Linked to Pancreas Disease
August 2013
Six recently approved diabetes drugs have been linked to an increased risk of pancreatitis and possibly pancreatic cancer.
Off Diabetes Pills!
July 2013
A recently published article mirrors our now-35-year-old publication “Off Diabetes Pills” in suggesting alternatives to pharmaceutical treatment for a large proportion of adult-onset diabetics.
Hypertension Drugs Plus NSAIDs May Injure Kidneys
April 2013
Recent evidence points to increased acute kidney injury associated with combining nonsteroidal anti-inflammatory drugs (NSAIDs) with two antihypertensive drugs: a diuretic plus either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). Find out the names of these drugs. This is especially important for patients with hypertension, diabetes, congestive heart failure or chronic kidney disease, because such patients are routinely treated with diuretics, ACE inhibitors and ARBs.
Sitagliptin With Simvastatin (JUVISYNC): A New Drug Combination to Avoid
March 2012
The article discusses the reasons why we have categorized JUVISYNC as a DO NOT USE drug.
A Review of the ‘Gliptin’ Diabetes Drugs
March 2012
Find out why you should not use any of the three recently-approved diabetes drugs known as "gliptins".
Inadvertent Adverse Reactions With Commonly Used Drugs
January 2012
Find out how to prevent emergency hospitalizations from two commonly used drugs, warfarin (COUMADIN) and clopidogrel (PLAVIX). There are approximately 33,000 emergency hospitalizations a year from warfarin alone. This article includes a list of more than 50 drugs that can have harmful interactions with warfarin and/or clopidogrel.
Bladder Cancer Warning for Pioglitazone (ACTOS)
November 2011
Find out the full list of serious problems with pioglitazone (ACTOS) that cause it to be a DO NOT USE drug, of which bladder cancer is but the latest.
Review of Type-2 Diabetes Medication Liraglutide (VICTOZA)
April 2011
This article reviews the safety and efficacy of liraglutide (VICTOZA), a new medication used to treat type-2 diabetes.
Saxagliptin (ONGLYZA) - Another Diabetes Drug
February 2011
This article discusses why you should not use this newly approved diabetes drug until more is known about its safety.
Update on Withdrawals of Dangerous Drugs in the U.S.
January 2011
This article lists 11 of the prescription drugs that we warned Worst Pills, Best Pills News subscribers not to use before they were banned by the FDA. Subscribers knew an average of 3.3 years before the FDA acted that these medications were unsafe to use.
Oral Drugs for Diabetes: Avoiding Hypoglycemia
May 2010
After explaining the symptoms of low blood sugar (hypoglycemia) the article lists 42 prescription drugs that can interact with one or more diabetes drugs to increase the chance of hypoglycemia.
Type 2 Diabetes Drugs Fail to Improve the Most Serious Long-Term Complications
February 2010
The article discusses why all of these 16 diabetes drugs carry a label stating: "There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction [heart attacks, strokes, etc] with oral antidiabetic drug[s]." The article also explains why lifestlyle changes such as diet and exercise to prevent or even treat type II diabetes are not heavily promoted or usually reimbursed.
A Review of Exenatide (BYETTA) for Type-2 Diabetes
November 2009
Because exenatide (BYETTA) is a new drug with increasing reports of severe, hospitalization-requiring pancreatitis and offers no significant breakthrough compared to other diabetes drugs, we urge readers not to use it until 2012--seven years after its approval, by which time much more will be known about its dangers.
Insulin Glargine (LANTUS) and Cancer: Is There a Link?
October 2009
We review recent studies potentially implicating one form of insulin in cancer and conclude that there is insufficient evidence to link the drug to cancer at present.
Public Citizen Urges Immediate Ban of Rosiglitazone (AVANDIA)
December 2008
On Oct. 30, Public Citizen formally petitioned the Food and Drug Administration (FDA) to immediately ban the dangerous diabetes drug rosiglitazone (AVANDIA) because the drug causes multiple types of serious toxicity.
Update: Diabetes Drug JANUVIA (Sitagliptin)
July 2008
An increasing body of evidence documents both the risks and lack of evidence of clinical benefits associated with sitagliptin, and several reviews have cautioned against its use.
Update on Rosiglitazone (AVANDIA): More Strikes Against the Drug
February 2008
Recent updates on this diabetes drug that we have urged our readers not to use for three years are reviewed, including the delisting of the drug by the Veterans Administration because of its dangers and warnings by the Canadian government. We are renewing our call for a ban on the drug in the U.S.
FDA: Women Taking AVANDIA, ACTOS at Increased Risk of Fractures
July 2007
Yet another reason has arisen to support our several years-old warning not to use the diabetes drugs AVANDIA or ACTOS. Randomized trials of both drugs, compared to other diabetes drugs, showed an increase in fractures in women (not men) using them.
New Findings: AVANDIA Poses Risks of Heart Attacks, Heart Failure
July 2007
In addition to years-old information about increased heart failure in patients using AVANDIA, that Worst Pills readers have been warned about for years, new evidence has emerged about increased heart attacks as well. The article reviews the evidence for both of these serious problems and why we continue to advise people not to use either AVANDIA or the related drug, ACTOS.
Sitagliptin (JANUVIA) for Type-2 Diabetes
June 2007
Worst Pills, Best Pills reviews side effects and long-term effects of type-2 diabetes drug sitagliptin (JANUVIA) in this article.
The Case Against The Diabetes Drug Rosiglitazone (AVANDIA)
December 2006
In addition, there was an almost significant 37 percent excess in the rosiglitazone group of what the authors called cardiovascular events composite, comprised of heart attacks, strokes, cardiovascular deaths, heart failure, the appearance of new angina attacks, and the need for heart surgery such as bypass or angioplasty. You have a greater likelihood of preventing type 2 diabetes by improving your diet and getting a moderate amount of exercise than by taking a prescription drug. The effects of such a change in lifestyle can last a lifetime.
Bogus Cures for Diabetes on the Internet
November 2006
A joint effort of the Food and Drug Administration (FDA) and the Federal Trade Commission(FTC) has resulted in recent warning letters to a large number of companies who are illegally marketing unproven diabetes treatments online. The article lists many of these products.
Some Diabetes Drugs May Cause Vision Problems: Rosiglitazone (AVANDIA) and Macular Edema
April 2006
If you experience visual deterioration while taking rosiglitazone (AVANDIA)or the combination of rosiglitazone with metformin (AVANDAMET), report this potential adverse drug reaction to your physician as soon as possible.
Dangerous, Inappropriate Prescribing Of Diabetes Drugs Metformin (GLUCOPHAGE), Rosiglitazone (AVANDIA), And Pioglitazone (ACTOS) To Patients With Heart Failure
September 2003
Government-sponsored research published in the July 2, 2003 Journal of the American Medical Association found that the diabetes drugs metformin (GLUCOPHAGE), rosiglitazone (AVANDIA), and pioglitazone (ACTOS) were being prescribed inappropriately to patients with heart failure and that the inappropriate prescribing of these drugs has been increasing over time.
NEW DRUG INTERACTION WARNING! Repaglinide (PRANDIN) For Diabetes And The Cholesterol Lowering Drug Gemfibrozil (LOPID)
August 2003
The European Agency for the Evaluation of Medicinal Products (EMEA) issued a public warning on May 21, 2003 not to use the combination of repaglinide (PRANDIN), a drug for lowering blood sugar in type-2 diabetics, and the cholesterol drug gemfibrozil (LOPID). The warning was based on a recent publication in the March 2003 issue of the medical journal Diabetologia that found the use of these two drugs in combination can enhance the blood sugar lowering effects of repaglinide and can thereby result in severe blood sugar lowering (hypoglycemia).
New Safety Labeling Change: Chlorpropamide (DIABINESE) for Type-2 Diabetes
September 2002
A new warning was added in May 2002 to the professional product labeling, or “package insert,” for the type-2 diabetes drug chlorpropamide (DIABINESE) concerning its use in the elderly. The new warning cites increased risks of low blood sugar (hypoglycemia), low blood sodium levels (hyponatremia), or both in patients aged 65 and over.

ADDITIONAL INFORMATION FROM PUBLIC CITIZEN
Petition to the FDA to Require a Black-Box Warning for Commonly Used Type 2 Diabetes Drugs Known as SGLT2 Inhibitors (HRG Publication #2529)
Public Citizen petitioned the Food and Drug Administration (FDA) to add a black-box warning to the product labeling for the commonly used Type 2 diabetes drugs known as SGLT2 inhibitors, as they can lead to potentially fatal diabetic ketoacidosis in Type 1 diabetes patients for whom the drugs are not approved.
Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding the Diabetes Drug Saxagliptin (HRG Publication #2253)
The Food and Drug Administration (FDA) should withdraw saxagliptin from the market because the large postmarket SAVOR trial demonstrated that the drug has unacceptable cardiovascular risks.
Letter to the Editor Published in Clinical Pharmacokinetics: Hepatotoxicity of Alogliptin (HRG Publication #2228)
Public Citizen criticizes a recent article published in Clinical Pharmacokinetics that concluded that “no hepatotoxicity has been reported” during the development of the diabetes drug alogliptin. However, after analyzing phase 2 and 3 pre-approval trials of alogliptin and post-marketing surveillance data for the drug from Japan, the Food and Drug Administration and European Medicines Agency concluded that the drug’s potential hepatotoxicity warranted inclusion of warning language in the drug’s label.
Acute Pancreatitis With Liraglutide: An analysis of MedWatch adverse event reports submitted to the Food and Drug Administration (HRG Publication #2204)
A new Public Citizen study referenced in a letter sent to the U.S. Food and Drug Administration (FDA), and posted online, reinforces the case that the diabetes drug liraglutide can cause pancreatitis and should be banned immediately by the FDA.
Testimony to FDA Endocrinologic and Metabolic Drugs Advisory Committee on Dapagliflozin for Treatment of Type 2 Diabetes Mellitus (HRG Publication #2173)
Public Citizen urges the agency not to approve dapagliflozin, a member of a new chemical class of drugs to treat type 2 diabetes mellitus, because it is no more effective than a similar diabetes drug, canagliflozin, approved by the FDA in March 2013, but does appear to pose additional safety hazards not seen with canagliflozin, including risks of bladder cancer and liver toxicity.
Testimony to FDA Drug Safety and Risk Management and Endocrine and Metabolic Drugs Advisory Committees Regarding Rosiglitazone Safety (HRG Publication #2134)
Public Citizen argues that not only should the current restrictions on the use of the diabetes drug rosiglitazone (Avandia) not be lifted, the drug should be removed from the U.S. market given its unique risks and the absence of any unique benefits. Among older patients with diabetes, rosiglitazone is associated with a significantly higher risk of heart failure and death compared to pioglitazone.
Petition to Ban Diabetes Drug Liraglutide (Victoza) (HRG Publication #2020)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately remove from the market the diabetes drug liraglutide (Victoza; Novo Nordisk) because the known increased risks of thyroid cancer and pancreatitis outweigh any documented clinical benefits.
Statement: FDA’s Rejection of Public Citizen’s Petition to Ban Rosiglitazone (Avandia) Translates to More Harm to Patients (HRG Publication #1985)
Late yesterday, the FDA faxed Public Citizen its letter rejecting our October 30, 2008 petition in which we asked the FDA to ban rosiglitazone (Avandia) because its benefits were greatly outweighed by its multiple risks, including increased heart attacks, heart failure, fractures, vision-threatening macular edema and other serious problems.
Testimony on Dapagliflozin (HRG Publication #1957)
A drug proposed to treat patients with diabetes should not be approved because it has serious risks and no evidence of clinical benefit.
FDA’s Partial Hold on Unethical Diabetes Drug Trial Does Not Do Enough to Protect Patients (HRG Publication #1916)
The Food and Drug Administration (FDA) has gone only half-way in stopping the unethical TIDE study by halting the recruitment of any new patients. To allow the experiment to continue at all is a major breach in the FDA’s obligation to protect people in clinical trials.
Testimony on Rosiglitazone (Avandia) Safety (HRG Publication #1913)
Rosiglitazone (Avandia) compares unfavorably to Pioglitazone (Actos) and should be removed from the market.
Letter Urging FDA to Halt Rosiglitazone (Avandia) Trial (HRG Publication #1908)
We urge the FDA to halt an international diabetes trial that would put patients at unnecessary risk.
Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness (HRG Publication #1903)
In contrast to becoming more active and cautious in enhancing food safety by removing potentially dangerous products before they have caused harm, several FDA decisions in the past year regarding prescription drugs can only be described as reckless.
Life-Threatening Liver Toxicity of Avandia Shown in New Public Citizen Research Published in Peer-Reviewed Medical Journal (HRG Publication #1886A)
WASHINGTON, D.C. - New research by Public Citizen published today in a peer-reviewed medical journal reinforces the case that the diabetes drug Avandia can cause death from liver failure and should be banned immediately by the Food and Drug Administration (FDA).
Petition to Immediately Ban Diabetes Drug Rosiglitazone (AVANDIA) (HRG Publication #1848)
The Food and Drug Administration (FDA) should immediately ban the dangerous diabetes drug Avandia because it can cause death from liver failure and has many other life-threatening risks that far outweigh its benefits.
Congress Must Act Quickly to Address Growing Crisis At the Food and Drug Administration
The Food and Drug Administration (FDA) is suffering from a crisis in leadership, a lack of congressional oversight and a dangerous reliance on the pharmaceutical industry to bankroll its operations, Sidney M. Wolfe, M.D., director of the Health Research Group at Public Citizen told a House of Representatives subcommittee this morning.
Comments on FDA's Draft Guidance for Industry - Drug-Induced Liver Injury: Premarketing Clinical Evaluation (HRG Publication #1833)
The FDA's guidance document confirms the agency's continued reluctance to seriously and publicly engage in post-mortem analyses of the growing number of mistakes the FDA has made concerning failed decision-making about either the approval of known hepatotoxic drugs or the dangerously delayed removal of ones showing hepatotoxicity shortly after approval.
Diabetes Drug Avandia Should Be Removed From the Market, Public Citizen Tells FDA Advisory Committee
The popular type 2 diabetes drug Avandia should be removed from the U.S. market, according to testimony delivered today by Public Citizen before a Food and Drug Administration (FDA) advisory committee panel investigating the medication.
FDA Knew of Avandia’s Dangers Nearly Five Years Ago, Memo Shows
The Food and Drug Administration (FDA) knew nearly five years ago about the dangers associated with the diabetes drug Avandia, an internal FDA memo shows.
Evidence Confirms Public Citizen’s Warnings About the Risks of Popular Diabetes Drug Avandia
Statement by Sidney Wolfe, MD, Director of Health Research Group at Public Citizen
Letter to FDA urging that the diabetes drug muraglitazar (PARGLUVA) not be approved because of an increased risk of serious adverse reactions including death (HRG Publication #1756)
Public Citizen urged the FDA to not approve the drug until, at the very least, a five-year randomized controlled trial is completed to more thoroughly assess the drug’s risks.
Testimony before FDA Advisory Committee on new diabetes drug Muraglitazar (PARGLUVA): Risks outweigh the benefits. (HRG Publication #1749)
Muraglitazar is a drug with modest ability to reduce hemoglobin A1C, but no proven ability to reduce the micro- and macrovascular complications that are the real concern in diabetes management.
Congressional Testimony by Sidney Wolfe M.D. on Current Issues Related to Medical Liability Reform (HRG Publication #1724)
Congressional Testimony on Current Issues Related to Medical Liability Reform (HRG Publication #1724)
Testimony before the Food and Drug Administration Endocrine and Metabolic Drugs Advisory Committee Meeting on pramlintide (Symlin), recommending that it not be approved and that no additional clinical trials be done (HRG Publication #1584)
We opposed the approval of Symlin because of increased severe hypoglycemia with automobile driving-related adverse events including crashes and confusion while driving (statistically significant); most people required paramedic intervention, ER visits and IV glucose administration; there was one death in an auto crash in a patient getting pramlintide.
Letter to the FDA requesting a criminal investigation of Warner Lambert/Parke Davis for what appears to be illegally delaying the submission of data known to the company before troglitazone was marketed. (HRG Publication #1515)
This letter is to request the opening of a criminal investigation of Warner-Lambert/Parke-Davis for what appears to be illegally delaying the submission of a compilation of data known to the company before marketing had begun--clearly showing troglitazone-induced liver toxicity--until after the drug was marketed.
Petition to the Food and Drug Administration requesting that it immediately require labeling for the diabetes drugs troglitazone (Rezulin), rosiglitazone (Avandia) and pioglitazone (Actos)(HRG Publication #1514)
Class efficacy issues include the lack of efficacy compared to previously available drugs, sulfonylureas, and the deterioration of blood sugar levels when patients are switched from other oral anti-diabetic drugs to the glitazones. Safety issues include liver toxicity, effects on heart function, weight gain, edema, anemia, low blood pressure, elevated lipid levels, and possible changes in progesterone levels.
Letter to the Editor in the Journal of the American Medical Association in response to an article on the safety of Food and Drug Administration approved drugs which were withdrawn (HRG Publication #1502)
Letters-Science by Peter Lurie, M.D., M.P.H. Larry Sasich, Pharm.D., M.P.H. Letter to the Editor in the Journal of the American Medical Association in response to an article on the safety of Food and Drug Administration approved drugs which were withdrawn
Statement before the Food and Drug Administration Endocrine and Metabolic Drugs Advisory Committee meeting advising them to withdraw troglitazone from the U.S. Market. (HRG Publication #1476)
John Doe was an otherwise healthy 45 year old Washington D.C. policeman who was started on Rezulin in the late summer of 1998, preceded by perfectly normal liver tests. Within a week after he started taking the drug, well before he was due for another liver test, he became seriously ill, was hospitalized at Johns Hopkins with acute liver failure.
Petition to the Food and Drug Administration to ban troglitazone/Rezulin due to its causing several cases of liver failure. (HRG Publication #1449)
We have obtained information from the FDA that as of June 5, 1998, there had been at least 21 deaths from liver failure and three patients requiring liver transplants caused by the recently-approved diabetes drug, troglitazone (Rezulin-Parke- Davis/Warner Lambert).