Paroxetine and adult patients

Article 31 analysis

In June 2003, a review of paroxetine clinical trial data was initiated by European regulators in a process known as an "Article 31 referral". As part of this process, GSK was asked to provide specific analyses of its clinical trial data to evaluate the risk of suicide, suicidal thoughts and behaviours, and self-harm, with particular attention to potential risk factors including age and gender. GSK submitted the first set of analyses to the initial Article 31 questions in September 2003, the second set in January 2004 and a third set in March 2004.

At that time, the European Committee for Human Medicinal Products (CHMP) performed a full risk-benefit review of paroxetine which resulted in a CHMP Opinion dated April 2004. In December 2004, the CHMP reaffirmed these conclusions following consideration of three new epidemiology studies which utilized the UK General Practice Research Database.

The documents provided below contain GSK's responses to questions that had a primary focus on suicidality prepared during the Article 31 review - both in adults and paediatrics. The responses are provided as they were submitted to European regulators and are based on the analyses conducted at that time.

Please also see the information on the 2006 analyses.

Article 31 questions*

September 2003 Questions & Appendices

January 2004 Questions

January 2004 Appendices

March 2004 Question

* Some appendices did not generate additional data

** Appendix 1 relates to Questions 1, 4, 8, 9, 11, 13, 15, 27