Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
TEL:  020 7273 0400
FAX:  020 7273 0675	.
	21 October 2002

Dear Mr Medawar,

CSM expert ad hoc group on safety of SSRIs

Thank you for your letter of 16 October 2002 asking about the expert meeting on the safety of SSRIs that we are holding in November and for your offer to attend the meeting.

It may be helpful if I clarify the position. It is our normal practice to convene ad hoc expert groups involving relevant scientific experts from CSM to explore in detail specific safety issues. The findings and recommendations of the group are then conveyed to the main CSM for their consideration and advice to the Licensing Authority. Dr Healy has submitted a body of research and scientific data to MCA on the issue of suicidal behaviour with SSRIs over the last few years. Dr Healy has been invited specifically to present his research in this area to the relevant CSM experts to ensure mutual understanding of these data. While it is not our normal practice to invite external researchers to present data to CSM ad hoc expert groups, we considered that it would be helpful on this occasion given the complexity of the issue. We have not had any correspondence with Dr Herxheimer in relation to this meeting.

Thank you for your offer to attend the meeting. We appreciate the information that you have provided on the subject of withdrawal reactions associated with paroxetine and will, as previously stated, be presenting this to the group. We consider the data that you have provided speaks for itself and you have made your position on these issues very clear. I do not think that it will be necessary for you to present to the group on this issue.

We will of course communicate any information or advice arising from the meeting that is in the public interest.

Yours sincerely,

Yours sincerely

DR J M RAINE,

Director, Post-Licensing Division

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