British ban use of antidepressant for kids

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Posted by Sadie from ? ( on Monday, June 23, 2003 at 1:39PM :

Nature 423, 792 (19 June 2003)

British panel bans use of antidepressant to treat children


UK regulators have ruled that a top-selling antidepressant should not be prescribed to children or adolescents who are suffering from depression.

The drug, paroxetine, is an ineffective treatment for major depression in this age group and could possibly increase suicidal tendencies, the Committee on Safety of Medicines (CSM) said on 10 June.

Paroxetine, a member of the same class of drug as Prozac, is widely used to treat depression and other nervous disorders. It is not licensed for use in children but can be prescribed by doctors on an individual basis — about 8,000 patients aged under 18 have been given the drug in Britain in the past year.

The CSM's ruling followed a review of fresh clinical data on 1,200 children treated with paroxetine for depression, social anxiety and obsessive–compulsive disorder. The information was provided by UK-based drug firm GlaxoSmithKline (GSK), which markets the drug under the name of Seroxat in Britain and as Paxil in the United States.

The data show that the children with depression did not benefit from taking the drug, the CSM said. It added that there was a two to three times higher incidence of "potentially suicidal behaviour" among those treated with the drug compared with those receiving a placebo, although total numbers were too small to be statistically significant.

The CSM did not rule on using paroxetine to treat social anxiety or obsessive–compulsive disorder, for which there was evidence of efficacy.

On 13 June, Senator Charles Schumer (Democrat, New York) called on the US Food and Drug Administration (FDA), to investigate the effects of paroxetine on children and teenagers. The FDA was expected to announce an investigation this week.

Over the past few years, GSK has been under increasing pressure from patients and their supporters, who say that paroxetine increases suicidal tendencies in all age groups. The company says that there is no evidence for this.

David Nutt, a psychopharmacologist at the University of Bristol, UK, says that the CSM ruling has little bearing on the debate about paroxetine's possible side effects in depressed adults. The CSM was concerned that the drug was ineffective in depressed children, so there was no reason to take any risk, he says.

© 2003 Nature Publishing Group

-- Sadie
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