Warnings, Not Ban, Urged for Diabetes Drug

07/31/2007

By Rick Weiss
Washington Post Staff Writer
Tuesday, July 31, 2007


A pair of Food and Drug Administration advisory panels called yesterday for new warnings for the widely used diabetes drug Avandia because of evidence that it significantly raises the risk of heart attack, but they stopped short of recommending that the drug be pulled from the market, as some FDA officials had urged.

The 22 to 1 vote to allow continued sales of the drug caps years of controversy among regulators, drug company officials, physicians and advocates for patients, who have offered dueling interpretations of contradictory safety studies. The pills are taken by more than 1 million Americans and racked up $3 billion in sales last year for their maker, GlaxoSmithKline of North Carolina.

Some analyses by experts inside and outside the agency have concluded that Avandia increases patients' heart attack risk by 30 percent or more. Several experts have also concluded that it makes no sense to wait for results from other studies because they were not designed in a way that will settle the question.

"Cardiovascular disease being the leading cause of death of people with diabetes, having a treatment that causes that is something that doesn't make sense to me," said Gerald Del Pan, director of the FDA's Office of Surveillance and Epidemiology.

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