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,

Thank you for your further letter of 3 August on the subject of SSRIs and suicidal behaviour.

Our summary on volunteer studies that was provided with my letter of 26 July was based on data provided by the marketing authorisation holders for these products. We do have access to the Hindemarch study, but would comment that the pattern of severe adverse effects and drop outs seen in this small study was not replicated in any other study involving sertraline. We are, however continuing to review these data.

You ask for a list of the epidemiological studies considered by CSM. These are attached. The references you mention in your letter have also been reviewed however it is not felt that they provide evidence that would warrant regulatory action other than that which is currently underway.

It may be helpful if I explain in more detail the regulatory action we are taking in relation to this issue. As part of an exercise to standardise and update, all SSRI SPCs the following warning about suicidal behaviour is being added to all SSRI SPCs:

'As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored during this period. The possibility of a suicide attempt is inherent in depression and may persist until significant therapeutic effect is achieved, and it is general clinical experience with all antidepressant therapies that the risk of suicide may increase in the early stages of recovery.'

The CSM considered that this statement accurately reflects the current knowledge on this issue. However they also considered that it was important that patients and the families of patients were made aware of a possible risk of an increase is suicidal behaviour and we are currently asking marketing authorisation holders for the SSRIs to add the following statement to patient information leaflets:

'Occasionally, thoughts of suicide or self harm may occur or may increase in the few weeks of treatment with < >, until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences.'

I would like to assure you that we are taking this issue very seriously and will look carefully at any further evidence which becomes available. The CSM has advised that this issue should be kept under close review.

Yours sincerely
Dr Keith Jones
Director & Chief Executive

References

Ashleigh EA &. Fesler FA. Fluoxetine and suicidal preoccupation. Am J Psychiatry 1992; 149(12):1750.

Fava and Rosenbaum. Suicidality and fluoxetine: is there a realtionship? J Clin Psychiatry 1991;52:108-111.

Jick S S, Dean A D, Jick H. Antidepressants and suicide. BMJ 1995; 310: 215-218

Leon A C, Keller M B, Warshaw M 0, Mueller T 1, Solomon D A, Coryell W & Endicott J. Prospective study of fluoxetine treatment and suicidal behaviour in affectively ill subjects. Am J Psychiatry 1999; 156: 195-210.

Mackay F J, Dunn N R, Martin M R, Pearce G L, Freemantle S N & Mann R D. Newer
antidepressants: a comparison of tolerability in general practice. British Journal of General Practice 1999; 49. 892-896.

Warshaw M G & Keller M B. The relationship between fluoxetine use and suicidal behaviour in 654 subjects with anxiety disorder.

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