A federal advisory panel has ruled that the first skin patch to treat attention deficit hyperactivity disorder (ADHD) in children is both effective and safe.
The panel also voted to recommend to the FDA the patch be considered an alternative treatment, for use only when taking pills is too difficult for a child.
Change of Opinion
This vote came shortly after a formerly skeptical FDA reviewer reversed his opinion about the drug. Dr. Robert Levin had said that trials showed troubling side effects too often. But before the panel vote, Levin told the committee he had reconsidered his opinion, and believed that the drug was safe.
Numerous Side Effects
During tests of the patch, some children reported side effects such as decreased appetites, headaches, insomnia, skin irritation, nausea and involuntary muscle spasms.
The patch, which, if finally approved by the FDA will be sold under the name Daytrana, is designed to go on a child's hip for nine hours. It releases methylphenidate, the same stimulant that is in Ritalin.
