The U.S. Department of Justice confirmed that its investigation into whether GlaxoSmithKline withheld data concerning adverse risk associated with Paxil has been expanded to include the U.S. attorney's office in Boston and is being coordinated in Washington.
Paxil, an antidepressant drug manufactured by GSK, was issued a warning letter by the U.S. Food and Drug Administration in 2006 stating that there were potential suicide risks among young adults taking the medication.
Lawyers for families of young adults that committed suicide and are suing Glaxo were asked by federal investigators for any information, documents and depositions concerning Paxil's possible link to suicidal behavior. Of special interest to the investigators was how that risk was portrayed to the FDA and doctors. Some believe that GSK was aware of the risk when it applied for U.S. approval from the FDA and that the company deliberately withheld that information.
In May 2007 the U.S. Food and Drug Administration updated the blackbox warning on all antidepressants to include a warning on the risk of suicidal behavior.
[Source: YahooNews]
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