Mr. RobertsonTo ask the Secretary of State for Health (1) what investigation he has made into the(a) side effects associated with and (b) general safety of Seroxat; [76966]
(2) what representations he has received regarding the safety of the anti-depressant drug Seroxat; and if he will make a statement. [76965]
505W
§ Ms BlearsThe 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 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 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/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, 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 which reached similar conclusions.
The product information for Seroxat which includes the summary of product characteristics for prescribers and the patient information leaflet, 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.