Medicines and Healthcare products Regulatory Agency Market Towers 1 Nine Elms Lane, London SW8 5NQ
Mr Charles Medawar Social Audit Ltd P.O. Box 111 London NW1 8XG	General enquiries Telephone 020 7273 0000  Fax 020 7273 0353 E-mail [email protected] www.mhra.gov.uk Direct line:  020 7084 2763 Email:   [email protected]

  

Ref:     06-083                                                                                                                                     3 July 2006 Seroxat/Placebo suicides Dear Mr Medawar,     I attach the results of the internal review conducted in response to your request dated 26 April 2006. You will see from the attached review that your complaint was upheld in relation to my response to your question whether the Agency stands by the inclusion of the "placebo suicide" which occurred after the trial cut-off point of 30 days. I would like to confirm that the Agency does not consider that a report of suicidal behaviour occurring more than 30 days after therapy was stopped should have been included in a post-treatment plus 30 day analysis. Yours sincerely, Sarah Wark Direct line 0207 084 2763

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