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FDA Advised to Pull Avandia From Market

July 30, 2007

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The U.S. government is looking into safety concerns about the diabetes treatment drug Avandia, with a top safety scientist urging that it be pulled from the market.

David Graham, a safety scientist with the Food and Drug Administration, told FDA advisors Monday the drug appears to increase risks of a heart attack.

The advice was contained in a slide, which was part of a presentation made to the advisory group but released in advance of the meeting.

Graham cited research to make his argument that there is no evidence of major health benefits from taking the drug, and that leaving it on the market may “cost thousands of lives.” The study in the New England Journal of Medicine linked Avandia with a 43 percent higher risk of heart attacks.

Earlier, government safety scientists advised the FDA that Avandia shouldn't be used in combination with insulin or by patients with heart disease.

GlaxoSmithKlein, the maker of Avandia, disputed Graham’s findings. The company said many studies have already been conducted, involving thousands of subjects, and that “there is no consistent or systematic evidence that Avandia increases the risk of heart attacks or death from cardiovascular disease compared to other drugs.

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 said it has been monitoring several heart-related adverse events based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports.

The agency 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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