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FDA Issues Safety Alert on Diabetes Drug Avandia

Studies Find Increase in Heart-Related Deaths

May 21, 2007

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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 However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated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.

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