Skin patch to treat ADHD gets the green light

Apr 10 2006

The Food and Drug Administration (FDA) in the U.S. has approved a skin patch to control attention deficit hyperactivity disorder (ADHD) in children.

The drug Daytrana, is the first patch-treatment for ADHD, and provides an alternative for six to 12 year olds who have trouble swallowing pills.

The approval is welcome news for the drug company Shire which has recently been affected by warnings from the FDA on other ADHD treatments including Adderall.

Two panels at the FDA have alerted the agency about the risk of heart attacks, hallucinations and paranoia, and called for stronger "black box" warnings on ADHD drugs.

It seems Daytrana will only need standard warnings including the risk of an allergic skin reaction.

The final approval follows tentative consent from the FDA in December.

The Miami-based Noven and Shire, a British drug company is also seeking approval for another ADHD treatment, NRP-104.

Hyperactivity is estimated to affect as many as 8 per cent of school-age children - more than 4 million in the US.

The patch is designed to treat ADHD children ages 6 to 12, and is attached to a person's skin for up to 12 hours every day.

The FDA had previously rejected the patch because of concerns it might overmedicate children.