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Vickye Young
Vickye Young
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FDA Issues Safety Alert on Avandia

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On May 21, 2007,the FDA issued a safety alert about Avandia (rosiglitazone maleate) after a study in the New England Journal of Medicine linked the popular diabetes drug to a 43% increase in the risk of heart attack and a 64% increase in the risk of death from all cardiovascular causes. Avandia has become a blockbuster drug for GlaxoSmithKline; since Avandia’s launch, over 6 million Americans have used the drug to treat adult-onset, or type 2, diabetes.

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.

The 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 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 this new information as they evaluate the available treatment options for their type 2 diabetes.

Avandia is manufactured by GlaxoSmithKline, which is based in Research Triangle Park, N.C.