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The U.S. Food and Drug Administration today warned that patients under age 18 should not take GlaxoSmithKline’s antidepressant Paxil because of a possible increased risk of suicidal impulses associated with the drug.
The statement from the FDA comes nine 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 drug generated global sales of about $3.4 billion last year, but it is facing the prospect of generic competition in the United States within the next 18 months.
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, doctors have had discretion to prescribe Paxil/Seroxat to young people on a so-called “off-label” basis.
Although companies are allowed to promote and market drugs only for approved uses, doctors are free to prescribe drugs to patients at their discretion.
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 8,000 patients under 18 receiving treatment.
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 under 18 taking the drug than in those receiving a placebo.
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