§ Mr. CatonTo ask the Secretary of State for Health (1) what assessment his Department has made of the accuracy of labelling and associated information material for the anti-depressant drug Seroxat, with regard to(a) side effects and (b) difficulty of withdrawal; [76226]
(2) what assessment his Department has made of the side effects of the anti-depressant drug Seroxat, including difficulty of withdrawal. [76227]
§ Ms BlearsSeroxat (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 UK, it must meet appropriate standards of safety, quality and efficacy. After licensing, the safety of all medicines, including SSRIs, is continually monitored by the Medicines Control Agency (MCA) and the independent expert advisory body, the Committee on Safety of Medicines (CSM), and any new evidence that emerges is carefully reviewed.
The MCA/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 presenters 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 a detailed review of all available data, 272W the CSM concluded that all SSRIs may be associated with withdrawal reactions on stopping, but that 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.
The product information for Seroxat, which includes the summary of product characteristics (SPC) for prescribers and the patient information leaflet (PIL), contains full 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.
§ Mr. SwayneTo ask the Secretary of State for Health if he will make a statement about the drug Seroxat. [76741]
§ Ms BlearsSeroxat (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 UK, it must meet appropriate standards of safety, quality and efficacy. After licensing, the safety of all medicines, including SSRIs, is continually monitored by the Medicines Control Agency (MCA) and the independent expert advisory body, the Committee on Safety of Medicines (CSM); any new evidence that emerges is carefully reviewed.
The MCA/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 a detailed review of all available 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.
The product information for Seroxat, which includes the summary of product characteristics (SPC) for prescribes and the patient information leaflet (PIL), contains full 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.