GlaxoSmithKline - Seroxat year 2000 suicidal behaviour SSRI core safety exercise

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SmithKline Beecham Pharmaceuticals

11 August 2000

Dear[text redacted S40 FOIA]

RE: SSRIs and suicidal behaviour

As you are aware, the Committee on Safety of Medicines (CSM) has recently reviewed the issue of fluoxetine and other SSRIs and suicidal behaviour. The Committee concluded that the available study data did not support a causal association between SSRIs and suicidal behaviour. However there continued to be anecdotal reports of suicidal behaviour associated with SSRIs. The Committee noted that it was general clinical experience that patients taking antidepressants may develop an increase in suicidal behaviour in the first few weeks of treatment.

The CSM considered that patient information leaflets for SSRIs should be updated to ensure consistency with the SPC statement introduced in the recent SSRI core safety exercise. They felt that the following wording was appropriate:


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

Your variation to update the SPC is currently under assessment. I would be grateful if you would submit a revised PIL including the above statement. I have assessed the PIL as it stands and no other amendments are required.

Please do not hesitate to contact me if you require any further information.

Yours sincerely
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Senior Scientific Assessor
Pharmacovigilance Group
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