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American Heart Association Comment: Advisory Committee Recommends that U.S. Food and Drug Administration Keep Rosiglitazone (Avandia) on the Market, Continue Clinical Trial of Safety and Efficacy
Date:7/14/2010

DALLAS, July 14 /PRNewswire-USNewswire/ -- After two days of hearings, an advisory committee to the U.S. Food and Drug Administration (FDA) recommended that the FDA allow the type 2 diabetes drug rosiglitazone (brand name, Avandia), to stay on the market, but with most committee members suggesting that the label be revised to include increased warnings. Rosiglitazone is one in a class of drugs called thiazolidinediones (TZDs), used to treat type 2 diabetes.

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The advisory committee voted 20 to 12 (with one abstention) to keep rosiglitazone on the market and recommended 20 to 10 (with two abstentions) that the TIDE trial continue. This trial, requested by the FDA, is evaluating patients with type 2 diabetes and a history of or risk for cardiovascular disease, and comparing the cardiovascular effects of long-term treatment with rosiglitazone, pioglitazone or placebo when added to standard care. The trial will also compare the effects of long-term supplementation with vitamin D on death and cancer.

The FDA will consider these recommendations and make a final ruling. "The advisory committee's deliberations were difficult, since the available data were limited, co
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SOURCE American Heart Association
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