GlaxoSmithKline has been examining the issue of suicidality in adults with depression and other psychiatric disorders since before paroxetine was approved. Over the past three years, GSK has conducted three analyses of adult suicidality: (1) the European Article 31 Referral (a European regulatory process involving a series of requests for analyses of clinical trial data), conducted during 2003 and 2004; (2) a 2004 report of the UK's General Practice Research Database (GPRD), an epidemiological database; and (3) an analysis recently completed in 2006 that is similar to FDA's ongoing review of antidepressants and suicidality. The results of the 2006 analysis indicate that young adults, particularly those with Major Depressive Disorder, may be at increased risk for suicidal behavior with paroxetine. While the individual studies comprising these analyses have already been made available on the GSK Clinical Trial Register, GSK is taking the additional step now of posting to this Web page the following documents:
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