MHRA-LOGO.gif (6825 bytes) 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]

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