Health written question – answered on 4th May 2004.

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Photo of Doug Naysmith Doug Naysmith Labour/Co-operative, Bristol North West

To ask the Secretary of State for Health if he will make it his policy that SSRI anti-depressants carry a warning that they may make patients suicidal.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

The safety of the selective serotonin reuptake inhibitors (SSRIs) has been closely monitored by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Government's independent expert advisory committee, the Committee on Safety of Medicines (CSM) since first authorisation.

The CSM has considered the question of suicidal behaviour in association with adult use of SSRIs on a number of occasions and has advised that it is general clinical experience that patients taking any anti-depressant may develop an increase in suicidal behaviour in the first few weeks of treatment. Prescribers were informed of this advice in an article in the drug safety bulletin, "Current Problems in Pharmacovigilance", in 2000 and advised that patients thought to be at risk should be monitored carefully, especially in the early stages of treatment.

Product information for patients for all SSRIs contains warnings that suicidal behaviour may increase in the early stages of treatment with any anti-depressant and that any patient who has suicidal thoughts should seek urgent medical attention.

In December 2003, CSM advised that four SSRIs (paroxetine, sertraline, citalopram, escitalopram) and the related anti-depressant, venlafaxine, should not be used in treating children and adolescents under 18 years with depressive illness because clinical trials had not demonstrated efficacy in this population and there was evidence of an increased risk of adverse effects, including suicidal behaviour and self-harm compared to placebo. The product information (summary of product characteristics and patient information leaflets) for these SSRIs contains appropriate warnings.

A Europe-wide review of the safety of paroxetine led by the United Kingdom and the Netherlands was completed on 22 April 2004. The European scientific advisory committee, the Committee for Proprietary Medicinal products (CPMP) recommended that paroxetine should not be used in children and adolescents and that there should be careful monitoring during paroxetine treatment of patients at risk of suicidal behaviour, including those with a history of suicidal behaviour and young adults. The CPMP recommendations are now subject to consideration by the European Commission.

The CSM's expert working group on the safety of SSRIs is continuing to review the available evidence relating to the safety of all SSRIs, with particular reference to behavioural disorders, including, suicidality to ensure that the advice in the product information is optimal for safe use of these medicines.

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