FDA advisers say first ADHD patch is safe and effective

WASHINGTON Copyright 2005 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. — 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 only as an alternative treatment for children with ADHD — in effect, saying doctors should prescribe it 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.