RESTRICTED/CONFIDENTIAL SCOP 98/1ST MEETING

NOT FOR PUBLICATION

COMMITTEE ON SAFETY OF MEDICINES

SUB COMMITTEE ON PHARMACOVIGILANCE

TITLE: Withdrawal reactions associated with SSRIs and related antidepressants.

Summary

Background: There have been a large number of spontaneous reports of withdrawal reactionsassociated with the SSRIs, in particular with paroxetine. A recent publication 'The Antidepressant Web' makes the claim that antidepressants, and in particular the SSRIs are drugs of dependence. In the light of this recent paper, data on withdrawal reactions associated with the SSRIs and the related antidepressants nefazodone and venlafaxine have been reviewed to investigate the nature of the withdrawal reactions and to search for any evidence that these drugs are associated with features of dependence.
Data reviewed: Published literature, UK and foreign ADROIT data, PEM data, information provided by MA holders and by the EU member states.
Main findings: Withdrawal reactions occur with all SSRIs and related antidepressants, although to different extents for each drug. In the main, these reactions are mild and self-limiting, although more severe reactions have been reported. No strong evidence has been identified to suggest that the SSRIs and related antidepressants cause features of dependence other than physiological withdrawal symptoms.
Regulatory implications 1. Product information for citalopram, nefazodone and fluoxetine should contain a general warning relating to withdrawal reactions.

2. References to withdrawal reactions being rare should be removed from the warnings in the product information for fluvoxamine and sertraline.

3. An article in 'Current Problems in Pharmacovigilance' should be published to remind doctors of the possibility of withdrawal reactions with SSRIs and related antidepressants.
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