FDA advisory panel calls ADHD patch effective, safe

WASHINGTON (AP) -- A federal advisory panel determined Friday that the first skin patch to treat attention deficit hyperactivity disorder in children is both effective and safe, bringing the patch a step closer to regulatory approval.
However, the panel of independent experts voted to recommend to the Food and Drug Administration that the patch's label encourage its use as an alternative treatment for children with ADHD -- in effect, saying doctors should prescribe it only if taking pills is too difficult for a child.
The unanimous vote by the FDA's Psychopharmacologic Drugs Advisory Committee, saying the patch was acceptably safe, came after a formerly critical FDA reviewer reversed his opinion about the drug.
The agency will now decide whether to approve the patch. It usually follows the advice of its advisory committees but is not required to. A decision is expected by Dec. 28, said a spokesman for U.K.-based Shire Pharmaceuticals Group PLC, which developed the patch along with Noven Pharmaceuticals Inc. of Miami.
Side effects
In documents posted by the FDA, agency reviewer Dr. Robert Levin had said that trials showed the patch produces troubling side effects too often to be considered safe. But on Friday, Levin told the committee he had reconsidered his opinion and now judged the drug was safe enough to approve.
The patch is designed to go on a child's hip for nine hours, according to submissions by the companies that developed it. It releases into the body methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin.
The patch is designed for children between the ages of 6 and 12. The developers said it is a way to treat ADHD in children for whom taking pills is difficult or unpleasant. Unlike a pill, it can be removed from the body if it causes harmful side effects.
Some children who received the patch during trials reported decreased appetites, headaches, insomnia, nausea and tics, the FDA said.
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