Seroxat (Hansard, 10 June 2003)

§ Baroness Andrews

Following interest in both Houses about the issues surrounding the safety of selective serotonin re-uptake inhibitors (SSRIs), including Seroxat, we are informing the House of new advice from the Committee on Safety of Medicines (CSM) against the use of Seroxat in children under the age of 18 for the treatment of depressive illness.

New data from clinical trials 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 SSRIs and the CSM. These data do not demonstrate efficacy in depressive illness in this age group and show an 28WA increase in the risk of events including 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, CSM has advised that the balance of risks and benefits of Seroxat is unfavourable when used to treat depressive illness in this age group. CSM has advised that Seroxat should not be used in children and adolescents under the age of 18 years to treat depressive illness. Ministers have accepted the committee's advice.

Seroxat is not and never has been licensed for use in those under 18 but it is used in this age group outside its licensed indications where prescribers make a judgement 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 with the CSM issuing advice in 2000 and 2001. 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 advice urgently in the event of such symptoms.

The recent concerns expressed by patient groups and in the media over the safety of Seroxat have been taken very seriously. In response to concerns of an association of Seroxat with withdrawal reactions and suicidal behaviour, a new expert working group of the CSM has been convened to further review the safety of 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 will be incorporating the experiences of patients in its safety evaluation.

Communications to patients and prescribers are taking place today. The expert working group of the CSM, convened to look at the wider issues relating to the safety of SSRIs, will examine urgently what implications, if any, these new findings have for the use of Seroxat in adults and for other SSRIs. The benefits of taking Seroxat are well established and patients over 18 and patients who are benefiting from Seroxat should not be frightened into stopping their medication. Patients who are experiencing any side effects or are concerned about their treatment should discuss these with their doctor.

The Government are committed to ensuring that the wider aspects of suicide prevention remain at the top of the agenda and the National Institute for Mental Health in England has made suicide prevention one of its core policy programmes.