Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 020 7273 0100/0546
Facsimile  020 7273 0548	.

Dear Dr Healy,    

Re: SSRIs and the risk of suicide

Thank you for your letters of 20 December and 5 January enclosing further information as discussed to our meeting of 13 December. I am very sorry indeed for the delay in response. Thank you also for your letter of 12 February to Dr Jones.

We found the meeting last December extremely helpful and have read with interest the further information that you have sent. We are seeking expert advice on the new data. Thank you also for your proposals for revised wording for the patient information leaflets. We are currently in the process of implementing the wording in patient information leaflets as agreed by the Committee on Safety of Medicines in June 2000. As you know the CSM warning does not, on the evidence available, attribute causality, but does give advice that medical attention should be sought.

In relation to your question to Dr Jones, the data relating to the Hindmarch study which was available to us in August of last year was a synopsis (4 pages long). We have since received further information and are considering how to further investigate the adverse effects experienced by volunteers. When we have received the information we have requested from all marketing authorisation holders, we will again seek expert advice.

You should already have received documentation relating to the CSM discussion on SSRIs and suicide and should be hearing shortly from Miss Sarah Wark with a copy of the paper on the core safety exercise for SSRIs.

We look forward to receiving the further information when this is available. I note your closing comments to Dr Jones and would stress, as we did at the meeting, that this issue is under ongoing review, that we are keen to receive any new evidence and to re-evaluate risk and benefit, and that our CSM experts will be kept informed.

Thank you again for your help.

Yours sincerely
Dr June Raine
Director of Post-Licensing

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