Anti-depressant Drugs (Hansard, 16 June 2004)

§ Paul Flynn
To ask the Secretary of State for Health if he will set a date by which the current Review of SSRI and related anti-depressant drugs will be completed and published; and what the reasons are for the delay in completing it. [178235]

§ Mr. Burstow
To ask the Secretary of State for Health (1) when the review of selective serotonin reuptake inhibitors and related anti-depressant drugs will be(a) completed and (b) published. [178458]
(2) what the reasons are for delays in completing the review of selective serotonin reuptake inhibitors and related anti-depressants; [178468]

§ Ms Rosie Winterton
[holding answer 15 June 2004]: The review of the safety of selective serotonin reuptake inhibitors by the Committee on Safety of Medicines' expert working group has taken longer than expected because of the need to examine a large amount of data from a wide variety of new and existing sources. The expert working group expects to publish its report later this year.

§ Paul Flynn
To ask the Secretary of State for Health what the best estimate of(a) the Medicines and Healthcare Products Regulatory Agency and (b) the Committee on the Safety of Medicines of the incidence of withdrawal reactions to Seroxat was in (i) July 1997 and (ii) July 2003; and if he will make a statement on the figures. [178236]

§ Tim Loughton
To ask the Secretary of State for Health what the reasons were for the differences in the best estimate of the Medicines and Healthcare Products Regulatory Agency and the Committee on Safety of Medicines of the incidence of withdrawal reactions to Seroxat in July 1997 and July 2003. [178339]

§ Mr. Burstow
To ask the Secretary of State for Health what estimate was made by the Medicines and Healthcare Products Regulatory Agency of the incidence of withdrawal reactions to Seroxat in(a) July 1997 and (b) July 2003. [178522]

§ Ms Rosie Winterton
[holding answer 15 June 2004]: Data were not available in July 1997 to allow a good estimation of the incidence of withdrawal reactions with paroxetine by the Medicines and Healthcare products Regulatory Agency (MHRA) or the Committee on Safety of Medicines (CSM). In July 2003, the best estimate of the incidence of withdrawal reactions by the MHRA and CSM, based on analyses of clinical trials was that 25 per cent. of patients had experienced symptoms on withdrawal of paroxetine. Information about the potential for paroxetine to cause withdrawal reactions has been included in the product information since the time of licensing and has been updated to take account of the new data on incidence.

§ Tim Loughton
To ask the Secretary of State for Health when he expects the current review of selective serotonin reuptake inhibitors and related996W anti-depressant drugs to be completed and published; and for what reasons this review has not been published earlier. [178721]

§ Ms Rosie Winterton
The review of the safety of selective serotonin reuptake inhibitors by the Committee on Safety of Medicines' expert working group has taken longer than expected because of the need to examine a large amount of data from a wide variety of new and existing sources. The expert working group expects to publish its report later this year.

§ Mr. Willis
To ask the Secretary of State for Health what guidance his Department has issued in relation to the prescription of selective serotonin reuptake inhibitors. [178960]

§ Ms Rosie Winterton
[holding answer 15 June 2004]: Guidance on how to use selective serotonin reuptake inhibitors (SSRIs) safely and effectively is provided in the product information for prescribers, the summary of product characteristics, and in the patient information leaflet which accompanies the medicine. These documents are authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) at the time of licensing and updated through the life of the product as new information on risks and benefits emerges. Information on prescribing is also provided in the British National Formulary, which is sent to all doctors in the national health service.
As with all medicines, the safety of SSRIs is continually monitored by the MHRA with independent expert advice from the Committee on Safety of Medicines (CSM). Articles have been published in the MHRA/CSM drug safety bulletin, "Current Problems in Pharmacovigilance in 1993, 2000 and 2003". These articles alerted prescribers to safety issues with SSRIs, in particular the risk of withdrawal reactions and the need to monitor carefully patients at risk of suicidal behaviour. The September 2003 edition of "Current Problems in Pharmacovigilance" contained a fact sheet for patients to aid discussions with their doctor about the appropriate use and possible side effects of their medicine.
The safety of SSRIs is currently undergoing intensive review by an expert working group of the CSM. Advice has been communicated to doctors and patients as each stage of the review has been completed. In December 2003, the CSM issued advice on the use of SSRIs in children and adolescents and published summaries of the clinical trial data on which this advice was based on the CSM website. In March 2004, the CSM issued a reminder to doctors on the recommended dose of paroxetine (Seroxat) in the treatment of depressive illness.