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Volume 407: debated on Friday 20 June 2003

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To ask the Secretary of State for Health (1) what plans his Department has to restrict the availability of Seroxat to (a) children and (b) adults; [119551](2) what advice his Department will issue to GPs regarding the prescription of Seroxat to adults. [119552]

New data from clinical trials of paroxetine (Seroxat) in children and adolescents were received by the Medicines and Healthcare products Regulatory Agency (MHRA) at the end of May 2003. These new data have been reviewed by an expert working group on selective serotonin reuptake inhibitors (SSRIs) and the Committee on Safety of Medicines (CSM). The data do not demonstrate efficacy in depressive illness in this age group and show an increase in the risk of episodes of self-harm and potentially suicidal behaviour in the Seroxat group compared to placebo. Various analyses suggest that the risk of these events is between 1.5 and 3.2 times greater with Seroxat compared to placebo. On the basis of these data, the CSM has advised that Seroxat should not be used in children and adolescents under the age of 18 years to treat depressive illness. This advice was communicated to health professionals via the Public Health Link on 10 June 2003 and was placed on the MHRA website, along with information for patients. Revised patient information leaflets containing the new advice are being sent to prescribers and pharmacists.Seroxat is not licensed for use in those under 18, but it is used in this age group outside its licensed indications where prescribes make a judgment on their own responsibility that it is the right treatment for a particular patient.SSRIs, including Seroxat, have been under close continuous review by the MHRA and the CSM for a number of years. The product information for SSRI antidepressants already contains advice that suicidal thoughts and behaviour are likely to increase in the early stages of treatment of depression (as with all antidepressants) and patient information leaflets already contain advice to seek medical attention urgently in the event of such symptoms.The CSM formally reviewed the issue of suicidal behaviour with SSRIs most recently in December 2001 and concluded that the evidence was not sufficient to confirm a causal association between SSRIs and suicidal behaviour, although an effect in a small high-risk population could not be ruled out. The CSM has advised that Seroxat is an effective treatment for adults with depressive illness and anxiety disorders and that the benefits of treatment outweigh the risks.The expert working group of the CSM will examine urgently what implications, if any, these new findings from clinical trials in children have for the use of Seroxat in adults and for other SSRIs.

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 antidepressants' safety. [119780]

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.