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Seroxat ban raises doubts over drug licensing system

By Jeremy Laurance, Health Editor

11 June 2003

Doubts were raised on the effectiveness of Britain's system for monitoring drugs yesterday after the Department of Health said Seroxat, Britain's most widely used antidepressant, should not be prescribed to people under 18 because of safety concerns.

Professor Alasdair Breck-enridge, chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA), said evidence from nine studies of Seroxat in young peoplebecame available to the agency on 27 May. They showed an increased risk of suicidal thoughts and self-harm among those under 18 and that the drug was ineffective in treating depression in this group.

"The balance of risk and benefit is unfavourable. The drug should not be used in young people,'' he said.

Seroxat was licensed for adults in 1990 but has never been licensed for children and young people. Doctors have prescribed it to up to 8,000 under-18s in cases where they take personal responsibility.

The results of the nine studieswere submitted to the MHRA by GlaxoSmithKline, makers of Seroxat, as part of preliminary moves to obtain a licence for the drug to treat obsessive compulsive and social anxiety disorder in under-18s. The disclosure raises doubts over whether the risks would have come to light had GlaxoSmithKline not sought to extend its licence.

Richard Brook, chief executive of the mental health charity Mind, said yesterday: "We do need to understand how the relationship between the pharmaceutical companies and the MHRA works, how companies provide data and how this relates to patients.''

Mr Brook was satisfied that the MHRA acted as soon as it could. But that left open the question of whether GlaxoSmithKline submitted the evidence promptly as some of the studies ran many years ago.

June Raine, director of the post-licensing division of the MHRA, said yesterday: "We always ask questions as to the timely presentation of data. We haven't got a definitive position to give you today.''

Seroxat is taken by 600,000 to 800,000 adults. The MHRA said it would "urgently examine" the implications of the studies for adults but a "causal association" with suicidal behaviour was not established.

The agency established an expert panel to assess Seroxat's safety after a BBC Panorama programme on the subject last autumn, which provoked 67,000 phone calls and 1,400 e-mails.

GlaxoSmithKline said in a statement yesterday that it supported the MHRA advice but disagreed with it. "Today's move will inevitably limit the choices available to doctors treating [young people with depression]. The conclusions we draw from the data differ.''

Alastair Benbow, head of European Psychiatry at GlaxoSmithKline, said: "We have acted entirely properly in this. If we had not seen the signals of efficacy in obsessive compulsive disorder and social anxiety disorder in young people we would still have brought this information forward.''

The MHRA warned young people on Seroxat yesterday not to stop taking it suddenly but to consult their GPs. People doing well on the drug might be able to continue but others would have to withdraw gradually.


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