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Pfizer - were asked to a add suicide warning on Lustral/Zoloft Aug 2000

April 9 2009 at 10:01 PM
Anonymous 

http://health.groups.yahoo.com/group/SSRI-Crusaders/message/33916       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]

Manager, Regulatory Affairs

Pfizer Limited

14 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 sertraline, 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 about to be submitted. I would be grateful if you would revise PIL to include the above statement.

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

Yours sincerely

[text redacted S38 FOIA]

Senior Scientific Assessor

Pharmacovigilance Group

Copy: [text redacted S38 FOIA]



 
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Responses

  1. Solvay - asked to add a suicide warning on Faverin/Luvox Aug 2000 - Anonymous on Apr 9, 10:02 PM
    1. Lundbeck - asked to add a suicide warning on SSRIs Aug 2000 - Anonymous on Apr 9, 10:03 PM
      1. Eli Lilly - asked to add a suicide warning on Prozac Aug 2000 - Anonymous on Apr 9, 10:04 PM
        1. GSK - asked to add a suicide warning on SSRIs Aug 2000 - Anonymous on Apr 9, 10:06 PM
     
  2. Pfizer - Solvay - Lundbeck - Lilly - GSK - all asked to put suicide warning on SSRI - Niam on Apr 10, 9:26 AM
    1. deluded or just in it for the money ? - Anonymous on Apr 10, 9:54 AM
      1. deluded, just in it for the money or duped by Svengali Lawyers & their PR company? - Anonymous on Apr 10, 9:58 AM
    2. Atypical greedy lawyer - svengali-bloaticus - Anonymous on Apr 10, 10:18 AM
      1. Atypical lawyers enjoying a feeding frenzy - Anonymous on Apr 10, 10:42 AM
        1. Hugh James admit it rejects 40% of potential claimants - Anonymous on Apr 11, 8:49 AM
          1. Tree shaker Mark Harvey "applications for legal aid" April 2002 - Anonymous on Apr 11, 9:28 AM
    3. Good Relations Wales - clients include Hugh James - Anonymous on Apr 10, 10:28 AM
      1. did Good Relations warn of the attrition rate at Hugh James ? - Anonymous on Apr 11, 8:51 AM
        1. did BBC Panorama Shelley Jofre warn that Hugh James junks 40% of potential claimants - BBC paid for by public funding on Apr 11, 8:55 AM
          1. Did BBC Panorama warn that all SSRI's linked to suicide (year 2000) not just Seroxat - BBC paid for by public funding on Apr 11, 9:04 AM
            1. How many people did you condem to death Shelly Jofre - BBC paid for by public funding on Apr 11, 9:08 AM
     


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