Ms S Wark, Post-Licensing Division
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ	28 September 2006

 

Dear Sirs,

FOI REQUEST

I am seeking to establish why doctors in the UK were first notified of the contraindication against concurrent use of pimozide and paroxetine in the paroxetine SPC published on 13 September 2006, when doctors in Canada were so advised by means of a Dear Doctor letter from GlaxoSmithKline, dated 22 July 2005. Given the risk of life-threatening adverse reactions, why was this warning delayed for 15 months, and why does the current pimozide SPC not refer to this contraindication to use?

Please provide copies of all communications (2005-2006) relating to the concurrent use of pimozide and paroxetine between the Agency and GlaxoSmithKline.

Yours faithfully                                                      
Charles Medawar

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