A patch developed to treat attention deficit hyperactivity disorder in children received a negative review from a Food and Drug Administration scientist, who concluded the drug cannot be safely marketed.
The patch uses methylphenidate, the same drug that is in Ritalin. But FDA reviewer Dr. Robert Levin found the patch produces troubling side effects too often to be considered safe. His findings were in briefing documents released by the agency on Thursday in advance of a public meeting on the drug.
The reviewer's findings are not the final word. An independent panel of experts convened by the FDA is expected to consider on Friday whether the patch is effective and safe. The FDA has the final call on whether the patch can be made available, but the agency often follows the advice of its panels.
The patch, developed by Noven Pharmaceuticals of Miami and Shire Pharmaceuticals Group in the United Kingdom, goes on a child's hip for nine hours, according to submissions by the company. It releases into the body methylphenidate, a stimulant that calms children with ADHD. It is for children between the ages of 6 and 12.
Noven pitched the patch as a way to treat ADHD in children for whom taking pills is difficult or unpleasant. It can also be removed if it causes any side effects.
But some children who received the patch during trials reported decreased appetites, headaches, insomnia, nausea and developing tics, the FDA said. Some also had skin irritation where the patch was applied. These occurred more often than in children taking Concerta, a pill that uses methylphenidate, and those taking a placebo, the FDA said.
In documents submitted to the FDA, the developers of the patch said it was safe and that problematic side effects were similar to those occurring in children who take methylphenidate orally.
It is the second time Noven has submitted the patch to the FDA. In 2003, The agency rejected a previous proposal for a 12-hour patch, and recommended Noven test the patch with a nine-hour application.
But in the FDA documents, Levin wrote the nine-hour patch "does not appear to be significantly more acceptable" than the 12-hour version. "Generally, it appears that the identical safety concerns remain," he wrote.
The patch would be sold under the name Daytrana.
In a statement on its web site, Noven acknowledged the FDA documents but did not comment on the agency's findings.