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Friday, June 20, 2003

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FDA recommends Paxil for adults only

Agency says it may raise child's risk of suicide

By Lauran Neergaard
AP medical writer

      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 Seroxat.
      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 adults.
      The FDA has never approved use of Paxil in children or teens. But some doctors prescribe the adult drug for children anyway.
      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.



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