Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0100/0546
Facsimile 0171- 273 0548 .
Dr David Healy, Director
University of Wales College of Medicine
North Wales Department, Hergest Unit
Ysbyty Gwynedd, Bangor, Gwynedd, LL57 2PW 22nd February 2000

Dear Dr Healy,

Thank you for your' letter of 19 January 2000 to Dr Jones on the subject of antidepressants and suicide and for enclosing a copy of your study. Your letter has been passed to the Post-Licensing Division of the MCA for response, since monitoring the safety of licensed medicine is our responsibility.

We will be considering the study on the emergence of antidepressant induced suicidality very carefully and will get back to you in due course. We would be interested to see a copy of the full study report if this is available.

We note that you consider the warning relating to suicide in the Prozac SPC to be inadequate and as new information emerges, we will consider any implications this may have for the warnings in product information.

Turning to your point about the collection of adverse reaction data in clinical trials, you mention that patients who went through these clinical trial programmes have put both themselves and the rest of us in a state of "legal jeopardy". We would be grateful for further clarification of what you mean by "legal jeopardy".

Yours sincerely
MISS SARAH WARK Cc
Senior Scientific Assessor
Post-Licensing Division		 Dr K Jones MCA/Dir
Dr J Raine MCA/PL
Dr P Waller MCA/PL

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