---

Dept of Health

Answer

Mrs. Calton: To ask the Secretary of State for Health (1) what plans he has to expedite the review of (a) Seroxat and (b) other selective serotonin reuptake inhibitors; [119777] (2) what plans he has to improve the warnings given to (a) prescribers and (b) the public about the (i) side-effects and (ii) withdrawal effects of (A) Seroxat and (B) other selective serotonin reuptake inhibitors; [119778] (3) what plans he has to improve the effectiveness of the Yellow Card scheme for reporting adverse side- effects of drugs; [119779] (4) if he will withdraw Seroxat from use for new prescribing pending a review of its and other SSRI anti- depressants' safety. [119780] Dr. Ladyman: A new expert group of the Committee on Safety of Medicines (CSM) has been convened to further review the safety of selective serotonin re-uptake inhibitors (SSRIs) and to ensure the advice in the product information for both patients and prescribers is optimal for the safe use of these products. This group has been asked to examine what implications, if any, the CSM's recent advice on the use of Seroxat in children have for the use of Seroxat in adults and for other SSRIs. The timetable for the group's programme of work has been planned with a view to the availability of advice as promptly as possible, commensurate with a full and detailed consideration of the evidence including the experiences of patients. As part of its initial considerations, the group has advised on strengthened advice on side effects and withdrawal reactions for inclusion in the patient information leaflet on Seroxat. Product information for other SSRIs will also be considered. The advice of the CSM, most recently in 2001, is that the benefits of Seroxat, when used in adults for licensed indications, outweigh the risks. Regulatory authorities world-wide have also taken a similar position. Depression and anxiety disorders are serious conditions that can cause severe suffering and are associated with an increased risk of suicide. The availability of effective treatments is critically important. In the absence of evidence indicating that the risks of using Seroxat in adults outweigh the benefits, it would be difficult to justify withdrawing the medicine from use. The Yellow Card Scheme is recognised to be one of the best in the world in terms of the level of reporting, has a proven track record of identifying new drug safety hazards and enables the monitoring of all medicines, including Seroxat, in clinical use. The effectiveness of the Scheme is under continuous review by the Medicines and Healthcare products Regulatory Agency and the CSM. From April 2003, the first phase of patient reporting of suspected adverse drug reactions via NHS Direct was introduced. When fully rolled out in England and Wales, this will enable the first hand experiences of patients to be utilised in the identification and assessment of drug safety issues. Other measures to further strengthen the Yellow Card Scheme include a new regional monitoring centre, established in Scotland last year and the inclusion of education on yellow card reporting in the training of nurse prescribers.

Secondary information

Type

Written question

Reference

407 c488-9W;407 c489-90W; 119777;119778;119779;119780

Session

2002-03

Subjects

Information Prescription drugs Safety Side effects Paroxetine Antidepressants Yellow card scheme

Link

View this Written question on www.publications.parliament.uk