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Professor Rolf Bass,
Head of Human Medicines Evaluation Unit
European Medicines Evaluation Agency
7 Westferry Circus, Canary Wharf

16 April 1998

Dear Professor Bass,

Further to my letter of 20th February, I am now enclosing a table including résumés of all the published reports I have been able to find of withdrawal and dependence-related problems with SSRI antidepressants. This should be read in the light in the light of two considerations I trust no good European would miss:

1. Given this evidence, plus evidence from spontaneous ADR reporting systems, how can one trust the official view that withdrawal problems are rare and mild, and no risk of a major dependence problem exists?

2. In the light of these risks, why are the SPCs/data sheets so poor? With some SSRIs (eg fluoxetine) there are no warnings. With others, there are bland footnote-style reassurances about apparently insignificant events (eg "Symptoms, including headache, nausea, dizziness and anxiety, have rarely been reported after abrupt discontinuation of Faverin" (fluvoxamine), or merely "Rare cases of withdrawal reactions have been reported" with sertraline.)

You will appreciate our concern about this, and therefore why I would be pleased to know what progress has been made with evaluation of the SSRI dependence risk you told me the EMEA had initiated. Is there any proposed completion date, and could you also let me please let me know which experts were appointed to conduct this review, and whether they propose to publish the full evidence on which their recommendations will be based?

Many thanks for your attention; I shall look forward to hearing from you

Yours sincerely,

Charles Medawar


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