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FDA Lifts Constraints On GlaxoSmithKline (GSK) Diabetes Drug Avandia



11/26/2013 6:45:07 AM

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Health regulators said on Monday they would lift restrictions on the use of GlaxoSmithKline Plc's once widely prescribed diabetes drug Avandia, after determining that it did not increase the risk of heart attacks. The U.S. Food and Drug Administration, following its review of a large clinical trial aimed at determining the drug's heart safety called Record, said it found that the trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared with standard-of-care diabetes drugs. These data do not confirm the signal of increased risk of heart attacks that was found in an analysis of previous clinical trials first reported in 2007, the FDA said in a statement.

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