§ Mr. David StewartTo ask the Secretary of State for Health what representations he has received on the use of the drug Seroxat; and what research he has(a) commissioned and (b) evaluated on the effects of the drug [83518]
§ Ms Blears[holding answer 2 December 2002]: The Medicines Control Agency (MCA) has received a range of representations including parliamentary questions, letters from hon. and right hon. Members, patients and health care professionals about the safety of Seroxat.
Seroxat (paroxetine) is a member of a group of drugs known as selective serotonin reuptake inhibitors (SSRIs). Before a product is granted a licence for use in the United Kingdom, satisfactory evidence of safety, quality and efficacy is required. After licensing, the safety of all medicines including SSRIs is continually monitored by the MCA and the independent expert advisory body, the Committee on Safety of Medicines (CSM) and any new evidence which emerges is carefully reviewed.
The MCA and the CSM carried out a major review of all side effects associated with SSRIs, which was completed in 2000 and resulted in product information for all SSRIs including Seroxat being updated and harmonised to reflect the common safety profiles of these medicines. An article in Current Problems in Pharmacovigilance in 2000 informed prescribers about this review and reminded them about the risk of withdrawal reactions.
Withdrawal reactions are an important and well-recognised side effect of Seroxat and also occur with the other SSRIs. The MCA/CSM warned prescribers about the possibility of withdrawal reactions associated with Seroxat via an article in the bulletin Current Problems in Pharmacovigilance in 1993. The CSM re-reviewed the issue of withdrawal reactions and possible dependence with Seroxat and the other SSRIs in 1998–99. From detailed review of all available data, which included spontaneous reports, published literature, clinical trials and usage data, the CSM concluded that all SSRIs may be associated with withdrawal reactions on stopping but on current evidence they are not associated with dependence. As a result of this review product information for all SSRIs was updated in relation to withdrawal reactions. This issue was also reviewed at a European level by the Committee on Proprietary Medicinal Products (CPMP) which reached similar conclusions.
968WThe product information for Seroxat which includes the summary of product characteristics for prescribers and the patient information leaflet contains details of side effects and warnings about withdrawal reactions. Doctors are advised to consider gradual tapering of dose when Seroxat is discontinued rather than abruptly stopping to avoid withdrawal symptoms.
The MCA/CSM is currently undertaking an intensive review of the safety of SSRIs, and in particular withdrawal reactions with Seroxat. When this is complete, any new advice will be communicated to prescribers and patients.