The Pharmaceutical Journal
Vol 270 No 7253 p813
14 June 2003

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MHRA: Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk)

Paroxetine linked with suicidal behaviour in under 18s

Paroxetine (Seroxat) must not be used for the treatment of children with depression because there is a risk that the drug may cause suicidal behaviour in those under 18-years of age, according to the Department of Health.

The warning, issued this week, follows an analysis of new clinical trial data received by the Medicines and Healthcare products Regulatory Agency at the end of May.

The combined data, from nine trials involving 1,697 children and adolescents aged 7–18 years, showed that more patients treated with paroxetine displayed potentially suicidal behaviour than those given placebo (3.4 per cent versus 1.2 per cent). Paroxetine also failed to show efficacy for the treatment of major depression in this age group.

At a press briefing organised by the Department, Professor Alasdair Breckenridge, chairman of the MHRA, stressed that adult patients should not be alarmed by the announcement and that they should not stop taking their antidepressant medication. However, he added: "The expert working group [set up by the Committee on Safety of Medicines to review the safety of selective serotonin reuptake inhibitors, SSRIs] will now urgently examine the implications, if any, for use of Seroxat and other SSRIs in adults."

At the same briefing, Dr Jonathan Chick, a consultant psychiatrist at the Royal Edinburgh Hospital, warned that patients should not stop taking paroxetine suddenly. "The dose should be tapered using half tablets then going to alternate days over several weeks," he said.

He told The Journal that children currently prescribed paroxetine should ideally be referred for family therapy or cognitive behavioural therapy. However, he acknowledged that a lack of specialist psychiatric units means that a lot of patients do not have access to the non-drug treatments. "That is why a GP may turn to an SSRI," he said.

He suggested that where a child's condition is severe and when other psychiatric therapies are not available, treatment could be gradually transferred to fluoxetine.

The MHRA has written to health care professionals informing them of the new safety information and setting out the new prescribing advice (see Panel below).

In response to the warning, Dr Alastair Benbow, head of European psychiatry for GlaxoSmithKline, manufacturer of Seroxat, commented: "While ... the conclusions we draw from the data differ, we recognise the MHRA's decision for UK paediatric patients and we will work with them to implement the changes as soon as possible."

He pointed out that no suicides occurred in the paediatric trials, which included over 1,000 patients treated with paroxetine.

Dr June Raine, head of postlicensing division, MHRA, explained that the trials had been carried out over a number of years and that the warning followed "a gradual accrual of data that built up a clinical picture".

She added that there was no suggestion that GSK had failed to provide the data in a timely fashion.

Paroxetine is not licensed for use in children but the MHRA estimates that approximately 7,000–8,000 patients under 18 years of age were treated with it last year.