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The Blog of Drug Discovery News

GSK out more than $2 billion in settlement

GlaxoSmithKline PLC recently took a $2.36 billion charge to settle most Avandia product liability cases and other litigation facing the company. The settlements include lawsuits regarding the diabetes drug Avandia (rosiglitazone) and liability and antitrust litigation over its drug Paxil (paroxetine). For Avandia, which a joint U.S. Food and Drug Administration (FDA) advisory committee voted should remain on the market with labeling or prescribing restrictions, a “substantial majority” of product liability cases has been resolved, the company says. The FDA also recently announced that it is investigating whether GSK failed to fully inform the agency about heart risks associated with Avandia. According to the FDA, GSK defended the drug’s safety to the agency and the public while debating internally about data and analyses pointing to increased cardiac risks. Later, after the drug was approved, GSK produced two separate sets of new data, finding that heart side effects jumped by 29 percent and 31 percent in Avandia patients, but did not disclose this data until May 2006, the FDA says.

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September 5, 2010 - Posted by | Corporate, Government | , ,

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