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Keep Diabetes Drug Avandia on the Market, FDA Advised

Posted on: Tuesday, 31 July 2007, 06:18 CDT

By Rita Rubin

The popular diabetes drug Avandia should remain on the market despite evidence that it can increase the risk of heart attacks, members of two Food and Drug Administration advisory committees recommended Monday.

Their decision came after a day of listening to scientists from the FDA and Avandia maker GlaxoSmithKline. The FDA sought the advice of the advisory panels after The New England Journal of Medicine posted a study May 21 that suggested Avandia could increase heart attack risk. Advisory panel recommendations are not binding, but the agency usually follows them.

Committee members voted 20-3 that Avandia increases heart risks. But they also voted 22-1 that the drug's risk/benefit profile merits it staying on drugstore shelves.

Most panelists who voted in favor of keeping Avandia on the market suggested a variety of labeling changes, including a "black box" warning about its effect on heart attack risk and new "contraindications" stating it should not be used in high-risk patients, such as those with a history of coronary artery disease or those who have also been long-term users of insulin.

"We welcome this decision as positive for patients," said Ronald Krall, Glaxo's chief medical officer. "The committee recognized the debilitating nature of this disease and the importance of multiple treatment options."

In the New England Journal study, Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, pooled the results of 42 clinical trials of Avandia. He found that Avandia patients were 43% more likely to have a heart attack or be hospitalized for blocked coronary arteries than others in the trials.

Glaxo has argued that Nissen's study, called a meta-analysis, is inherently flawed, and that its own research has failed to find a significantly increased risk of heart attacks in Avandia users.

Before Nissen's study was posted, about 1 million Americans with type 2 diabetes took Avandia, according to Glaxo, but that figure has dropped to about 900,000. More than 18 million Americans have type 2 diabetes.

David Graham of the FDA's Office of Surveillance and Epidemiology told panelists Avandia should come off the market. The drug probably caused 80,000 heart attacks and deaths since it came on the U.S. market in 1999, he said.

Actos, the other drug in the same class as Avandia, does not appear to increase heart attack risk, he said. (c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.

Source: USA TODAY

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