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Seroxat

Volume 406: debated on Friday 23 May 2003

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To ask the Secretary of State for Health what recent discussions he has had with the Medicines Control Agency about the drug Seroxat. [114100]

Since the marketing of Seroxat (paroxetine) in 1990, the Secretary of State for Health has been kept informed by the Medicines Control Agency (MCA), and since 1 April 2003 the Medicines and Healthcare products Regulatory Agency (MHRA) on matters relating to its safety. The MCA has sought the advice of the Government"s independent expert scientific advisory body, the Committee on Safety of Medicines (CSM).

In the last two months the Secretary of State for Health has been informed of the on-going action relating to the selective serotonin reuptake inhibitors (SSRIs), including Seroxat, in particular the convening of a CSM Expert Group to review the current available evidence on the safety of SSRIs, including patients reports submitted by MIND/Panorama; and the review of product information for all SSRIs to ensure that it provides necessary information to allow prescribers and patients to make informed decisions about appropriate treatment.

To ask the Secretary of State for Health what recent guidance has been or will be issued to GPs concerning the (a) use and (b) prescription of Seroxat. [114317]

Seroxat (paroxetine) is a member of a group of drugs known as selective serotonin reuptake inhibitors (SSRIs). Guidance on prescribing and use of Seroxat is provided in the authorised summary of product characteristics (SPC) for health professionals and patient information leaflet (PIL). These documents contain information on use of Seroxat, contraindications, warnings and possible adverse effects. Prescribing information is also included in the British National Formulary (BNF) which is sent by the Department of Health to doctors and pharmacists.Since Seroxat was first marketed in 1990, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Government"s independent expert advisory committee, the Committee on Safety of Medicines (CSM) have kept the safety of Seroxat under close continuous review. A number of communications have been issued to health professionals on the SSRIs via the MHRA/CSM drug safety bulletin "Current Problems in Pharmacovigilance". The most recent of these was an article focussing on the safety profile of the SSRIs in September 2000.A CSM expert subgroup has been convened to review available information on the safety of SSRIs, including patient reports, product information for Seroxat and the other SSRIs, with particular emphasis on supporting communications between healthcare professionals and patients.