FDA panel finds first ADHD patch safe, effective

WASHINGTON - 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...

Reviewer reverses decision

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....