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Volume 472: debated on Wednesday 5 March 2008

To ask the Secretary of State for Health pursuant to the answer of 25 February 2008, Official Report, column 1215W, on Seroxat, if he will issue new guidance on prescribing Seroxat. (191809)

Guidance on how to use paroxetine (brand name Seroxat) safely and effectively along with information on potential adverse effects is provided in the product information for prescribers (the summary of product characteristics) and in the patient information leaflet (PIL) 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 potential adverse effects and benefits emerges.

The Committee on Safety of Medicines Expert Working Group on the safety of selective serotonin reuptake inhibitors (SSRIs) has undertaken a comprehensive review of the safety of this entire class of drugs, including paroxetine. This review examined all available evidence. In December 2004 the Expert Working Group published its conclusions including that the balance of risks and benefits of all SSRIs in adults remained positive in their licensed indications. This is consistent with the view of the regulatory authorities in Europe and the United States that benefits of SSRIs outweigh the risk of adverse drug reactions and that they are effective treatment for depressive illness and anxiety disorders.

The National Institute for Health and Clinical Excellence (NICE) published a clinical guideline on the management of depression in primary and secondary care in December 2004. NICE is in the process of updating this clinical guideline with updated guidance expected in June 2009. NICE also published a clinical guideline on the identification and management of depression in children and young people in September 2005.

Since the completion of the review by the Government's Expert Working Group on the safety of SSRIs and publication of its findings, updated prescribing advice has been issued in relation to Seroxat as new information has become available.