§ Janet AndersonTo ask the Secretary of State for Health what advice he has received about the prescribing of Seroxat to people in the 18 to 29 years age group. [184292]
642W
§ Ms Rosie WintertonIn May 2003, the Government's independent scientific advisory committee, the Committee on Safety of Medicines (CSM), established an expert working group on the safety of Selective Serotonin Reuptake Inhibitors (SSRIs) because of continuing concerns about withdrawal reactions and possible suicidal behaviour associated with these products. The expert working group is still considering evidence regarding he safety of all SSRIs (including paroxetine). The group is expected to report on its findings later this year, and its report will be made available to the public with copies placed in the Library.
In June 2003, the CSM considered newly received clinical trial data for paroxetine in children and adolescents and, on the basis of these data and advised that paroxetine should not be used in patients under 18 years of age in the treatment of major depressive illness, because of evidence of an increased risk of suicidal behaviour and a lack of efficacy in this population group. This advice was communicated to prescribers and patients in June 2003 and again in December 2003.
In March 2004, the CSM issued advice to remind prescribes of the recommended starting and daily doses of paroxetine, as stated in the summary of product characteristics for this medicine.
A Europe wide review of the risks and benefits of paroxetine has also been undertaken by European Committee for Proprietary Medicinal Products (CPMP), with the United Kingdom in the lead. This review included an assessment of whether some young adults as well as those in the under 18 patient group may have an increased risk of suicidal behaviour when using this drug. No strong evidence has been found to support an increased risk and the CSM and the CPMP have advised that the balance of risks and benefits for paroxetine in the treatment of major depressive illness and anxiety disorders in patients of 18 years or older is favourable.
The CPMP has re commended that patients at high baseline risk of suicidal behaviour should be closely monitored during treatment with paroxetine. These include patients with a known history of suicidal behaviour or thoughts prior to starting treatment, and possibly young adults as a patient group. In April, a summary of the opinion of the CPMP referring to the need for monitoring, during paroxetine treatment of patients at risk of suicidal behaviour, including those with a history of suicidal behaviour and young adults was released by both the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The CPMP review and recommendations are now being considered by the European Commission, with final decisions expected in the near future. When decisions have been reached by the Commission, a review of the evident will be made public. If necessary, the product information for prescribers and patients will be updated and communicated, with details harmonised across the European Union.
643WThe MHRA emphasises that the patient information leaflet for Seroxat currently advises that symptoms of depression, including suicidal behaviour, may increase in the first few weeks of treatment and that patients should seek urgent medical attention if they have any distressing thoughts or experiences during this initial period or at any other time.