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Paxil Not for Kids, FDA Warns

Adult antidepressant can increase a child's risk of suicide, agency says after look at data.

June 20, 2003|From Associated Press

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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