HC Deb 27 March 2003 vol 402 c404W
Mr. David Stewart

To ask the Secretary of State for Health (1) what advice he has received from the Medicines Control Agency about the possible link between the use of the drug Seroxat and suicide; [104566]

(2) what representations he has received on the withdrawal of the antidepressant Seroxat; [104567]

(3) how many coroners have written to him expressing concerns about the drug Seroxat; and how many have called for urgent inquiries. [104565]

Ms Blears

Since it was authorised in 1990 the safety of paroxetine (Seroxat) has been closely monitored by the Medicines Control Agency (MCA) and the Government's independent expert advisory committee, Committee on Safety of Medicines (CSM). The CSM has considered the question of suicidal behaviour in association with Seroxat on a number of ccasions and carefully assessed any new data. The CSM has advised that there is insufficient evidence to confirm a causal relationship between Selective Serotonin Reuptake Inhibitors (SSRIs) and suicidal behaviour.

The 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 prescribes and patients for all SSRIs has been amended to include warnings that suicidal behaviour may increase in the early stages of treatment as 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.

Since 1997, the MCA has received a range of representations, including parliamentary questions, letters from hon. and right hon. Members, patients and health care professionals expressing concerns about the safety of paroxetine.(Seroxat), none of which have been from coroners.

The MCA and the CSM receive reports of suspected adverse drug reactions to medicinal products via the yellow card scheme. Since marketing authorisation was granted in 1990, the MCA and CSM have received 8,702 such reports for paroxetine (Seroxat). One of these reports has been received from a coroner. In addition the MCA has written to the coroner for Brecon to obtain further details of a recently publicised case.

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