FDA approves transdermal patch for ADHD

Washington -- The first transdermal patch to treat attention-deficit/hyperactivity disorder was given the nod April 6 by the Food and Drug Administration. The patch, Daytrana, which contains methylphenidate, was approved for use in children ages 6 to 12 and could be considered as an alternative for the pill form.

The patch is to be applied once a day to alternating hips and worn for up to nine hours, said Thomas Laughren, MD, director of the FDA's division of psychiatric products. The new form of medication was found to be safe and effective when examined in two clinical trials that included a total of 765 children.

More than 3 million school-age children in this country are believed to have ADHD.

The patch may cause the same side effects as do oral ADHD drugs containing methylphenidate, such as Ritalin and Concerta. Those side effects include insomnia and appetite suppression. Daytrana may also cause skin irritation at the patch's application site.

The same warnings not to prescribe stimulants for children with known structural cardiac abnormalities apply to the patch as for pill forms of the drug, said Dr. Laughren.

The agency had denied approval to the patch three years ago because it was thought to deliver too strong a dose. Its manufacturer had sought at that time to have the patch approved for 12 hours of wear. The new application for approval suggested a nine-hour wear period, and the FDA agreed.

The agency also agreed to approval after obtaining additional information from the manufacturer showing that the children in trials who developed skin reactions to the patch did not go on to develop contact sensitization rendering the drug ineffective in any form.

However, Dr. Laughren cautioned that there remains the potential for sensitization, so an extensive warning statement has been included in the Daytrana label.

In addition, the FDA notes that other treatment programs that include psychological, educational and social aspects of handling ADHD should be included.