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HomeCME CenterConference CenterLibraryDiscussionsMarketplaceHelp June 20, 2003  

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FDA Warns Against Paxil Use in Children


NEW YORK (Reuters) Jun 19 - The U.S. Food and Drug Administration (FDA) on Thursday warned that patients younger than 18 should not take GlaxoSmithKline's antidepressant Paxil (paroxetine) because of a possible increased risk of suicidal impulses.

The statement from the FDA comes 9 days after British regulators issued similar precautions for children and adolescents. The drug, one of Glaxo's top sellers, is known as Seroxat in the UK.

The medicine has been the subject of increased public concern because of reports of adverse reactions, prompting Britain to set up an expert panel to investigate.

Although only officially approved for adults, physicians have had discretion to prescribe Paxil/Seroxat to young people on an off-label basis.

Children account for a small portion of patients taking the antidepressant. For instance, a total of 4 million prescriptions were written for Seroxat in Britain last year, with around 8000 patients under 18 receiving the drug.

New data from various clinical trials showed episodes of self-harm and potentially suicidal behavior were between 1.5 and 3.2 times higher in patients younger than 18 taking the drug than in those receiving a placebo.

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