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Paxil Suicide Data Should be Investigated, Grassley Says

Jun 13, 2008 | Parker Waichman LLP

A U.S. lawmaker wants to know if the maker of Paxil withheld data regarding the popular antidepressant's association with suicide.  Sen. Charles Grassley (R-Iowa) has asked the Food & Drug Administration (FDA) to probe whether GlaxoSmithKline new of Paxil's suicide risk when it first sought approval for the drug.

Paxil - known generically as paroxetine - was brought to market by GlaxoSmithKline in 1992, and by 2006, Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.  

In September 2004, the FDA issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. The warning followed a report issued by Britain's Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil.

On May 12, 2006, the FDA issued another Paxil suicide warning when results of another study showed that Paxil increased suicide risk in young adults aged 18-30.  An analysis of multiple trials including 15,000 patients revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the placebo.  Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30.

But there is evidence that GlaxoSmithKline knew about the Paxil suicide risk long before the 2004 warning was issued.  In his letter to the FDA, Grassley cites a report by British regulators that found that Glaxo knew as far back as 1998 that Paxil was associated with a higher risk of suicidal behavior in adolescents.

Grassley also asked the FDA to review a report by a Harvard psychiatrist who had submitted information as part of several lawsuits. The report, written by Joseph Glenmullen, found that Glaxo "had to know of Paxil's suicide risk when it sought FDA approval for the drug," Grassley's letter said. Glenmullen found that Glaxo inappropriately inflated the suicide risk of a placebo during clinical trials of the antidepressant, obscuring the increased danger associated with Paxil.

In addition to the suicide risk, Paxil has also been linked to an increased risk of birth defects, especially those involving the heart.  In 2005, the labeling of Paxil was changed twice to reflect information from several studies that found this risk.  

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