HC Deb 02 July 2003 vol 408 cc348-9W
Paul Flynn

To ask the Secretary of State for Health (1) what his most recent assessment is of the safety of anti-depressant drugs; [121863]

(2) when his investigation into selective seratonin uptake inhibitors will recommence. [121864]

Ms Rosie Winterton

As with all medicines, the safety of antidepressant drugs is continually monitored by the Medicines and Healthcare Products Regulatory Agency, with independent expert advice from the Committee on Safety of Medicines (CSM).

A new expert working group of the CSM has been established to review further the safety of antidepressants of the selective serotonin reuptake inhibitor (SSRI) class. The group had its first meeting on 23 May 2003 and has had subsequent meetings on 4 and 20 June.

Mrs. Calton

To ask the Secretary of State for Health if he will make a statement on the safety of the drug Seroxat. [115789]

Ms Rosie Winterton

I refer the hon. Member to the written statement made by the then Parliamentary Under-Secretary of State with responsibility for public health, my hon. Friend the Member for Salford (Ms Blears), on 10 June 2003,Official Report, column 42WS.

Mr. David Stewart

To ask the Secretary of State for Health what investigations his Department is undertaking concerning the use of the drug seroxat. [116176]

Ms Rosie Winterton

[holding answer 3 June 2003]: A new expert group of the Committee on Safety of Medicines (CSM) has been convened to further review the safety of selective serotonin reuptake inhibitors (SSRIs), including seroxat and to ensure that the advice in the product information for both patients and prescribers is optimal for the safe use of these products. As part of its initial considerations, the group has advised on strengthened warnings on side effects and withdrawal reactions for inclusion in the patient information leaflet on Seroxat.

This group has been asked to examine what implications, if any, the CSM's recent advice on the use of Seroxat in children has for the use of Seroxat in adults and for other SSRIs.

The advice of 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.