WASHINGTON – The FDA on Thursday approved the first skin patch to treat attention deficit hyperactivity disorder in children.
The patch called Daytrana, designed to be worn for 9 hours, contains methylphenidate, which has been shown to help children with ADHD.
It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami.
In December, a Food and Drug Administration panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children ages 6 to 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child.
Unlike pill forms of the drug, the patch can be removed if it causes side effects.
Noven Pharmaceuticals in 2003 submitted a 12-hour version of the patch to the FDA. The agency rejected it and recommended that Noven test a nine-hour version. That is the version approved for use Thursday.
U.K.-based Shire Pharmaceuticals Group PLC co-developed the patch with Noven Pharmaceuticals.
Approval of the patch comes as use of methylphenidate and other ADHD drugs increases. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.
The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs.
A panel of outside experts recently recommended to the FDA that the drugs bear labels that caution users in plain language about possible dangers, including stroke and hallucinations. Earlier, another FDA panel recommended that the medicines include so-called "black-box" warnings. That is the strongest warning a prescription drug can bear.