Adult antidepressant
can increase a child's risk of suicide, agency says
after look at data.
WASHINGTON — No
one under 18 should be prescribed the drug Paxil for
major depression, because the adult antidepressant may
increase a child's risk of suicide, the government said
Thursday.
The Food and Drug Administration's recommendation came a
week after Britain issued an even stronger warning against
pediatric use of Paxil, sold there under the name Seroxat.
Children already
taking Paxil should not suddenly stop, the FDA stressed.
Some doctors may think the drug is helping enough to keep
a particular patient on the medication, which the FDA
warning doesn't forbid. Those who do stop taking Paxil
need medical supervision to taper off and avoid rebound
side effects, such as abnormal dreams and shock-like
sensations.
Paxil is approved for adult treatment of a number of
psychiatric illnesses, including depression. Although
lawsuits have been filed alleging Paxil caused violent or
suicidal reactions, the FDA said Thursday that there is no
scientific evidence linking the drug to increased suicide
risk among adults.
The FDA has never approved the use of Paxil by children.
But some doctors prescribe it for children anyway.
The agency had asked all makers of adult antidepressants
to submit research showing how their drugs affect
children. Three studies of Paxil found that it didn't
seem to help pediatric depression — but FDA scientists
spotted some safety concerns and ordered manufacturer
GlaxoSmithKline to reanalyze data.
That reanalysis found that the risk of suicidal thoughts
and suicide attempts was three times greater among Paxil
users, mostly teens, than among children given placebos,
the FDA said.
There were no deaths during the studies, but FDA officials
wouldn't release the number of suicide attempts, citing
manufacturer confidentiality.
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