Wednesday, February 24, 2010

Senate report: Avandia maker knew of cardiac risks (USA)

"A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public. Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee's ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007. The agency ordered a warning to be included on Avandia's label in 2007, saying that it might increase the risk of heart attacks, though the data on those risk was inconclusive. Soon afterwards Sen. Grassley, one of the FDA's toughest critics in Congress, disclosed that the agency's internal safety experts came within one vote of recommending a withdrawal of Avandia" - Washington Post

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