Paroxetine and adult patients

Introduction

GlaxoSmithKline has been examining the issue of suicidality in adults with depression and other psychiatric disorders since before paroxetine was approved. Over the past several years, GSK has conducted 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; (3) an analysis completed in 2006 that is similar to FDA's review of antidepressants and suicidality; (4) a 2002 analysis of results from a review of data regarding “suicide attempts” in paroxetine clinical trials originally submitted to FDA in 1991; and (5) a 2002 analysis of data submitted to FDA in 2001 regarding suicide attempts and suicidal thinking; the 2002 summary uses narrow and broad definition algorithms. Additionally, an excerpt from GlaxoSmithKline’s response on 15 February 2008 to a letter from Senator Grassley seeking information on Paxil and adult patients is provided.  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 Study Register, GSK is taking the additional step of posting to this web page the following documents: