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
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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