Complain about a product or service

FDA Issues Safety Alert on Diabetes Drug Avandia

Studies Find Increase in Heart-Related Deaths

May 21, 2007

Diabetes • FDA Approves New Type 2 Diabetes Treatment • Coffee And Tea May Reduce Diabetes Risk • FDA Warns Stolen Insulin Vials Could Still Be On The Loose • FDA Warns of Bogus Insulin • Public Citizen Seeks Avandia Ban • Blood Sugar Monitor Can Detect Early Diabetes • Studies Find Link Between Diabetes and Alzheimer's • Avandia Maker Failed To Report Required Data • Prediabetes: What You Should Know • Study: Large-Breasted Women More Diabetes-Prone • U.S. Diet Dishes Up Diabetes • Weight-Loss Surgery Seen Beneficial to Diabetics • Lack of Deep Sleep May Increase Diabetes Risk • Study: Avandia May Do More Harm than Good • FDA Orders New Warning For Avandia • U.S. Kidney Disease on the Rise • Fish Oil May Fight Diabetes • Avandia vs. Actos: A Doctor's Advice • Avandia Linked to 42% Greater Risk of Heart Attack • Soft Drink Sweetener Linked to Diabetes in Kids • Diabetes Drugs to Get 'Black Box' Warnings • FDA Rejects Advice to Pull Avandia From Market • FDA Advised to Pull Avandia From Market • Avandia, Other Diabetes Drugs Increase Risk of Heart Failure • Dairy Products May Protect Against Metabolic Syndrome • Portion-Control Dishes May Help Obese Diabetics • FDA Issues Safety Alert on Diabetes Drug Avandia • Stem Cell Treatment May "Cure" Diabetes • Diabetes Risk May Be In The Genes • Holiday Gluttony Can Spell Disaster for Undiagnosed Diabetics • Malaria Drug May Fight Common Cause of Diabetes, Heart Disease • Feds Attack Fake Diabetes Cures • FDA Approves New Treatment for Diabetes • Feds Warn Of Counterfeit Diabetes Tests • Study: Weightlifting Helps Overweight Teens Avoid Diabetes • Researchers Say They Can Reverse Type 1 Diabetes • Study: Obesity Major Factor in Diabetes Epidemic • Too Much, Too Little Sleep Linked To Diabetes In Men • Procedure Cures Some Diabetic Mice • Ethnicity Skews Diabetes' Effect on Heart • Pig Cells May Be Useful in Diabetes Treatment • Protein Triggers Fat-Saturated Cell Death • FDA Approves Diabetes Inhaler Exubera • FDA Panel Greenlights Diabetes Inhaler • Breastfeeding May Decrease Diabetes Risk • Low-Fat Dairy Products May Lower Diabetes Risk in Men • Scientists Find Diabetes "Switch" • New Diabetes Treatment Approved • Knowledge of Diabetes Doesn't Always Affect Outcomes • Moderate Exercise Helpful to Diabetes-Prone Women • Life Expectancy Increases; Diabetes Epidemic Worsens

The U.S. Food and Drug Administration (FDA) issued a safety alert on diabetes drug Avandia today after studies found an increase in heart-related deaths among patients taking the drug.

The consumer group Public Citizen said it has warned FDA repeatedly about the dangers of the drug.

"The New England Journal of Medicine study just released showing a 43 percent increase in heart attacks in people using Avandia should come as no surprise either to the Food and Drug Administration (FDA) or to Glaxo," said Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen.

"In animal studies done prior to its approval, one of the most constant findings was damage to the heart, and within the first six years of approval there have been 689 cases of heart failure reported to the FDA in patients using the drug," Wolfe said. "In addition, there have been reports of anemia which, along with heart failure, increases the risk for a heart attack."

But FDA was more cautious in its description of the risk, calling it "potential."

"Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia," the agency said.

FDA said that patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about the latest study.

Last Choice

Public Citizen said the drug should be a "last-choice" option.

"Despite prior knowledge of serious cardiac problems, the FDA has failed to require Glaxo to adequately warn about the dangers of this drug that should be, at best, a last-choice treatment for Type II diabetes," Wolfe said. "In addition to the accumulating evidence of its risks, it is not even as effective as other diabetes drugs in lowering blood sugar or hemoglobin A1C, a measure of glucose control."

"Because of inadequate warnings about Avandia and massive advertising campaigns, its popularity has grown so that 11 million prescriptions were filled for the drug in the United States in 2006 alone," Wolfe noted. He urged patients to avoid the drug.

FDA Still Studying

FDA said it was still analyzing the data and has not "confirmed the clinical significance of the reported increased risk in the context of other studies."

FDA noted there is "inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments" and said for that reason it is not asking GlaxoSmithKline to take any specific action at this time.

"FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."

Approved in 1999

Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation.

Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006.

The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.

Follow us on Twitter.