||FDA recommends Paxil for adults only |
Agency says it may
raise child's risk of suicide
WASHINGTON — No
one under age 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
Children and teenagers already taking
Paxil should not suddenly stop the pills, the FDA stressed. Some doctors
may feel the drug is helping enough to keep a particular patient on the
drug, 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. While there have been lawsuits alleging
Paxil caused violent or suicidal reactions, the FDA said Thursday there is
no scientific evidence linking the drug to increased suicide risk among
The FDA has never approved use of Paxil in
children or teens. But some doctors prescribe the adult drug for children
The FDA had asked all makers of adult
antidepressants to submit research showing how their drugs affect
children. Three studies of Paxil found it didn't seem to help pediatric
depression — but FDA scientists spotted some safety concerns and ordered
manufacturer GlaxoSmithKline to reanalyze the data.
That reanalysis — submitted last month, first to the British
government and then to FDA — found the risk of suicidal thoughts and
suicide attempts was three times greater among Paxil users, mostly teens,
than among children given dummy pills, the FDA said.