WASHINGTON -- A patch developed to treat attention deficit hyperactivity disorder in children received a negative review from a Food and Drug Administration scientist, who concluded that the drug cannot be safely marketed.
The patch uses methylphenidate, the same drug that is in Ritalin. FDA reviewer Dr. Robert Levin found that the patch produces troubling side effects too often to be considered safe. His findings were in briefing documents released yesterday by the agency in advance of a public meeting on the drug.
The reviewer's findings are not the final word. An independent panel of specialists convened by the FDA is expected to consider today whether the patch is effective and safe. The FDA has the final call on whether the patch can be made available, but it often follows the advice of its panels.
The patch, developed by
Noven pitched the patch as a way to treat ADHD in children for whom taking pills is difficult or unpleasant. It can be removed if it causes any side effects.
Some children who received the patch during trials reported decreased appetite, headaches, insomnia, nausea, and developing tics, the FDA said. Some also had skin irritation where the patch was applied. The side effects occurred more often than in children taking Concerta, a pill that uses methylphenidate, and those taking a placebo, the FDA said.