FDA Panel Says Keep Avandia on the Market

GAITHERSBURG, Md., July 14 (UPI) — U.S. Food and Drug Administration advisers voted Wednesday to keep the diabetes drug Avandia on the market, but perhaps with restrictions and new warnings.

Twelve of the pane’s 33 members voted for pulling the drug after the panel essentially concluded the research data showed sufficient evidence the drug increases heart attack and stroke risk, but that there was insufficient evidence it increases the risk for death, The Washington Post reported.

During a two-day meeting in Gaithersburg, Md., the scientific panel reviewed about 1,000 pages of information and listened to 18 speakers who presented more than 500 slides of data.

The panel recommended the FDA allow a large international study being conducted by GlaxoSmithKline to compare Avandia to another diabetes drug Actos. However, some on the panel disagreed because of concerns providing the drug to some patients with known safety concerns is unethical.

Critics of Avandia said the drug had risks and was unnecessary, since there are other diabetes drugs. Proponents of the drug said it may work well for some patients who do not respond well to an alternative.

After its FDA approval in 1999, Avandia became the world’s most popular drug to treat type 2 diabetes. In 2007, a Cleveland Clinic study indicated the drug significantly increased the risk for cardiovascular risk.

FDA Commissioner Margaret A. Hamburg will make the final decision about Avandia.

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