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GlaxoSmithKline Adds Safety Restrictions to Avandia Label

February 07, 2011
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The Associated Press reports that GlaxoSmithKline PLC has updated the labeling of its diabetes pill Avandia to include safety restrictions ordered by federal health authorities because of the drug''s links to heart attack. The Food and Drug Administration announced the changes in September as the last in a series of safety actions against the former blockbuster drug, which has triggered thousands of patient lawsuits and a Department of Justice investigation. The European Union has banned the drug. The new U.S. label indicates that Avandia is only intended for patients who cannot control their blood sugar with any of the other diabetes medications on the market. Patients who are currently on the drug can continue taking it after consulting with their doctor. The FDA first approved Avandia in 1999 and it became the top-selling diabetes pill in the world, with more than $3 billion in sales by 2006. But use has plummeted since a 2007 analysis first linked the drug to heart attack.

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