FOI 09/309 - MHRA have NOT received David Healy Withdrawal Protocol **Updated

From: Fawbert, Stephen Date: 21/08/2009 11:25:53 To: Jeremy Bryce Cc: Gregor, Simon Subject: FOI 09/309 - Healy Withdrawal Protocol

Dear Mr Bryce

Thank you for your email of 17 August to Simon Gregor which has been passed to me as Freedom of Information Act Coordinator for VRMM Division.

We have not received a revised withdrawal protocol dating from end of June or early July from Professor Healy.

As stated in previous correspondence the Summary of Product Characteristics, which is produced by the marketing authorisation holder and approved by the MHRA does not include information about the effects of venlafaxine on serotonin and noradrenaline at different doses. Guidance from the National Institute of Clinical Excellence (NICE) on the treatment of depression states that 'At the standard dose of 75mg, venlafaxine is an SSRI. At doses of 150mg/day and above it also inhibits the reuptake of noradrenaline and, to a lesser extent dopamine. I hope this information is helpful.

Yours sincerely Stephen Fawbert
Stephen Fawbert

Information for Public Health Group Vigilance and Risk Management of Medicines (VRMM)Medicines and Healthcare products Regulatory Agency (MHRA)Market Towers 14-1101, Nine Elms LaneLondonSW8 5NQ
Tel: 020 7084 2788
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