FDA panel: Keep Avandia, but add safeguards

The advice emphasizes the importance of balancing the risks and benefits of this diabetes drug for individual patients.

By Susan J. Landers, AMNews staff. Aug. 20, 2007.

Washington -- A pair of votes July 30 by a Food and Drug Administration advisory panel offered mixed recommendations for the agency and signaled caution for physicians who prescribe Avandia (rosiglitazone) to their patients with type 2 diabetes.

The panel examined safety data on the drug and voted by a wide margin, 22-1, to recommend that the agency keep Avandia on the market. But by a similar vote, 20-3, the panelists also recognized the increased risk for heart attacks posed by the drug and urged the agency to consider raising its warning level to black-box status or implementing a patient registration program, panelists said during a news conference.

The agency is not required to follow its advisory panels' recommendations but generally does.

Most primary care physicians treat many patients with type 2 diabetes. More than 14 million people in the U.S. have been diagnosed with the disease, according to National Institutes of Health figures. Those numbers are expected to grow as a result of the pounds being added to the nation's collective midsection.

Citing the vast numbers of people needing treatment, the drug's manufacturer, GlaxoSmithKline, said it welcomed the decision to keep the drug on the market. "The committee recognized the debilitating nature of this disease and the importance of multiple treatment options," Ronald Krall, MD, GSK's chief medical officer, said in comments on the panel's decisions.

The current spotlight on Avandia, which was first sold in 1999, resulted from the publication of a New England Journal of Medicine article in May warning that use of the drug was associated with an increased risk of heart attack compared with placebo. The article prompted the FDA to issue a warning on the use of the drug for people with underlying heart disease or those at high risk of heart attack.