Tuesday, July 31, 2007

FDA Stops Short of Pulling Avandia From Market

From today's Star-Tribune:

Diabetes drug can stay, FDA panel says

Despite evidence it increases risk of heart attack, Avandia may only get an added warning label.

By Rick Weiss, Washington Post

WASHINGTON - A pair of Food and Drug Administration advisory panels called Monday 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 22-1 vote to allow continued sales of the drug ends 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 $3.4 billion in sales last year for their maker, GlaxoSmithKline of North Carolina.

At least enough fuss has been raised about the drug so that people (and their doctors) will be aware of the risk involved. No doubt use of Avandia will decline, especially since there seem to be better alternatives available. Bonzo

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