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FDA recommends against treating ADHD with modafinil

http://www.100md.com   2006-3-24 xinhuanet
     WASHINGTON, March 23 (Xinhua) -- A U.S. Food and Drug Administration (FDA) advisory committee on Thursday recommended against using the narcolepsy drug modafinil to treat attention deficit hyperactivity disorder (ADHD) in children and teenagers.

    The psychopharmacologic drugs panel voted 12-1 against the recommendation.

    It concluded that the drug is effective against ADHD, but can't be regarded as safe for the use by children for the time being, reports reaching here said.

    The panel was most concerned about a possible link with skin rashes and recommended that the drug's manufacturer, Cephalon Inc., conduct a 3,000-patient trial to measure the risk.

    The drug is also found in link with psychiatric effects including mania and aggression.

    Modafinil is being marketed as Provigil for treating sleep disorders. Cephalon is seeking to sell the drug under the name Sparlon for children with ADHD. Enditem

    Editor: Zhu Jin