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Advisers: Diabetes drug should be available

Tuesday, July 31, 2007

WASHINGTON -- The widely used diabetes drug Avandia should remain on the market, government health advisers recommended Monday, saying evidence of an increased risk of heart attack doesn't merit removal.

The nonbinding recommendation to the Food and Drug Administration came on a majority vote by the panel. The tally wasn't immediately available.

However, in an earlier 20-3 vote, the panelists said that available data show the drug does increase heart risks. Panelists said the drug's warning label should be updated and there should be additional study.

Earlier, FDA scientist Dr. David Graham told the joint panel of experts that the drug's heart risks, combined with its lack of unique short-term benefits in helping diabetics control blood sugar, meant continued sales were not justified.

The manufacturer, GlaxoSmithKline PLC, argued that there is no increased risk, citing its own analyses of studies of Avandia, also called rosiglitazone.

"The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents," said Dr. Ronald Krall, the company's senior vice president and chief medical officer.

The FDA convened the experts to consider whether Avandia should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA had said information from dozens of studies pointed to an increased risk of heart attack.

The FDA isn't required to follow the advice of its advisory committees but usually does.

About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia might actually increase those risks would represent a "serious limitation" of the drug's benefit, according to the FDA.


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