§ Paul FlynnTo ask the Secretary of State for Health what assessment he has made of comments made by the coroner in the case of Mr. Whitefield about the drug Seroxat; and what plans he has to request a review of the safety of Seroxat. [103843]
§ Ms BlearsFollowing the tragic death of Mr. Whitefield two weeks after commencing treatment with paroxetine (Seroxat), an antidepressant of the Selective Serotonin Reuptake Inhibitor (SSRI) class, the Medicines Control Agency (MCA) has taken careful note of the comments of the coroner for Brecon. The MCA has also written to the coroner to obtain further details of Mr. Whitefield's case.
Since it was authorised in 1990 the safety of paroxetine (Seroxat) has been closely monitored by the MCA and the Committee on Safety of Medicines (CSM). The CSM has considered the question of suicidal behaviour in association with Seroxat on a number of occasions and carefully assessed any new data. CSM has concluded that there is insufficient evidence to confirm a causal relationship between SSRIs and suicidal behaviour.
CSM has advised that it is general clinical experience that patients taking any antidepressant may develop an increase in suicidal behaviour in the first few weeks of treatment. Product information for prescribers and patients for all SSRIs has been amended to include warnings that suicidal behaviour may increase in the early stages of treatment with any antidepressant. In September 2000, an article was published in the drug safety bulletin, Current Problems in Pharmacovigilance, which is distributed to all doctors and pharmacists.
An expert working group on the safety of SSRIs has been set up by the CSM to review the current available evidence relating to the safety of SSRIs, including paroxetine, particularly in relation to suicidal behaviour and withdrawal reactions. The expert working group will report its findings to CSM in due course.