Eli Lilly - asked to add a suicide warning on Prozac Aug 2000

http://health.groups.yahoo.com/group/SSRI-Crusaders/message/33919



The following information was supplied to Jeremy Bryce as a result of Freedom of Information request number - FOI 09 086

Mr Bryce asked which makers of antidepressants received a request (year 2000) to include the following statement in product information:

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





[text redacted S40 FOIA]

Eli Lilly and Company Limited

By Fax: 01256 315435

16 August 2000

Dear [text redacted S40 FOIA]

RE: SSRIs and suicidal behaviour

Thank you for your e-mail with the proposed wording relating to suicide for the Prozac PIL.

The wording that you propose implies that thoughts of suicide that are already present may not get better immediately. This is not entirely consistent with the wording recently added to the Prozac SPC which states that the risk of suicide may increase in early stages of recovery.

'Suicide: As improvement may not occur during the first few weeks of treatment, in common with all antidepressants, patients should be closely monitored during this period. The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. It is general clinical experience with all therapies for depression that the risk of suicide may increase in the early stages of recovery.'

I therefore request that you incorporate the following wording which is proposed by the CSM into the statement that Lilly have developed:

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

I will be away from the office from 18th to 1st August inclusive. In me absence, please contact [text redacted S38 FOIA]if you have any questions (telephone number [text redacted S38 FOIA]

Yours sincerely

[text redacted S38 FOIA]

Senior Scientific Assessor

Pharmacovigilance Group

Copy: [text redacted S38 FOIA]