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LETTERS: Kenneth D Shenderey Treating major depression in children and adolescents: Depressed adolescents may lose out BMJ 2004; 328: 525 [Full text]

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Points of clarification

Kate Lloyd   (8 March 2004)

Points of clarification 8 March 2004
Kate Lloyd, Medical Director, Pfizer Ltd Tadworth, Surrey KT20 7NT Send response to journal: Re: Points of clarification	Dear Sir Dr Shenderey (Brit Med J 28th Feb 2004) finds it unsatisfactory that the data on which the CSM has made its decision to contraindicate the use of sertraline in children, has not been published. However I would like to point him towards the publication of the two identical studies in children with depression carried out by Pfizer and published in JAMA 27th Aug 2003. As he suspects the data, on almost 400 children, aged 6 – 17 years treated in these studies, shows that there is no excess of suicides or suicide attempts in the active treatment group (2 suicide attempts in 2 subjects) compared with the placebo group (3 suicide attempts in 2 subjects). This data and the collected data on Obsessive Compulsive Disorder (OCD) for which sertraline is also licensed was presented to the MHRA and CSM, and despite this a contraindication has been required. Dr Herxheimer asks for urgent clarification on the use of SSRIs in other indications in children. For sertraline the data on OCD in 187 patients aged 6 years and above showed no suicide attempts, which perhaps reflects Dr Shenderey’s point that suicide is part of depression and not a major feature of at least some of the other indications for which SSRIs are approved. While Pfizer has never sought an indication for the use of sertraline in the treatment of childhood depression we remain convinced that the data does not support the conclusions drawn by the CSM. Yours sincerely Kate Lloyd FRCP FRCP(Edin) FFPM Medical Director Competing interests: The author is an employee of Pfizer