June 19, 2003, 1:38PM
FDA: Teens, children shouldn't use PaxilReuters News
NEW YORK - 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
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.