Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 020 7273 0763
Facsimile  020 7273 0675	.

Dear Dr Healy,

I am writing further to your request of 8 September 2000 to Dr Jones, made under the Code of Practice on Access to Government Information (the Code - copy enclosed), for the minutes and assessment report relating to CSM consideration of the issue of suicidal behaviour and SSRIs. Please accept my apologies for the delay in replying.

I am enclosing a copy of the assessment report and tabled paper which were considered by CSM in June of this year, and the relevant extract from the minutes of that meeting. As you will see, parts of the assessment report and the minutes have been edited under the exemptions outlined in the Code, which place certain restrictions on the disclosure of information. We have concluded that disclosing this information would not be appropriate because either it is likely to be addressed in legal proceedings (exemption 4(a) of the Code), or could facilitate an unwarranted invasion of an individual's privacy (exemption 12 of the Code).

If you have a query about this letter, please contact me. If you are unhappy with our decision, you may ask for it to be reviewed. A senior member of the Agency who has not so far been involved with your request will undertake that internal review. If you wish to ask for a review, you should write to Dr June Raine, at the above address, in the first instance. If you remain dissatisfied, you may ask a Member of Parliament to make a complaint on your behalf to the. Ombudsman (known officially as the Parliamentary Commissioner for Administration) who may decide to conduct his own investigation.

Yours sincerely	Copy: Dr K Jones MCA/PL
Sarah Wark	Dr June Raine MCA/PL
Senior Scientific Assessor, Pharmacovigilance Group	Dr P Harrison MCA/PL

 

10. SSRIs and Suicidal Behaviour

10.1 The Committee noted the paper and Tabled Paper M.

10.2 The Committee were informed that previous reviews of fluoxetine and suicide in the early 1990's had concluded that it was likely that fluoxetine was not causally associated with suicidal ideation, however information on high risk patients was lacking and concern remained.

10.3 The Committee considered the data collected since the last review, and the relevance of the recent publication of case reports of suicidal ideation in healthy volunteers given sertraline.

10.4 The Committee noted that there had been anecdotal reports of suicidal behaviour associated with fluoxetine, mainly in patients with complex psychiatric histories. The Committee also noted that it was general clinical experience that patients taking any antidepressants may develop an increase in depressive symptoms, including suicidal behaviour, in the first few weeks of treatment. The Committee commented that it was impossible to answer the question of whether fluoxetine and/or other SSRIs caused suicidal behaviour in a small subpopulation of patients. They considered that this issue should be kept under review and formally revisited every 2-3 years.

10.5 The Committee noted with interest the publication by Dr Healy which reported suicidal behaviour occurring in healthy volunteers given sertraline. The Committee felt that these reactions were difficult to explain, however data on from the marketing authorisation holders on adverse reactions experienced by volunteer given SSRIs were reassuring.

10.6 The Committee concluded that the available study data did not support a causal association between fluoxetine or other SSRIs and suicidal behaviour. They noted that the spontaneous reporting rate of suicidal behaviour for all SSRIs had been low in recent years, and that high reporting rates in the early 1990's were likely to be a result of the intense publicity surrounding the issue at that time.

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