The Food and Drug Administration warned yesterday that patients
younger than 18 should not take the 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 GlaxoSmithKline's top sellers, is known as Seroxat
in Britain.
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 Paxil is officially approved for adults only and
companies are allowed to promote and market drugs only for approved
uses, doctors have had discretion to prescribe Paxil or Seroxat to
young people on an "off-label" basis.
Children account for a small portion of patients taking the
antidepressant. A total of 4 million prescriptions were written for
Seroxat in Britain last year, with 8,000 patients younger than 18
receiving treatment.
New data from clinical trials showed episodes of self-harm and
potentially suicidal behavior were 1.5 to 3.2 times higher in
patients younger than 18 taking the drug than in those getting a
placebo.
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