FDA Approves First Skin Patch for ADHD
Methylphenidate-containing patch is designed to be applied once daily and worn for nine hours
WEDNESDAY, April 12 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first methylphenidate-containing transdermal patch for treating attention-deficit/hyperactivity disorder (ADHD). Known as Daytrana, the patch is designed for use in children ages 6 to 12 and is applied each morning to the alternating hip and worn for nine hours.
The amount of time the patch is worn can be varied to help manage efficacy and side effects, which may include insomnia, blurred vision, mild skin irritation or an allergic skin rash, and slower weight gain and height growth. "Stimulant products generally should not be used in children with known structural cardiac abnormalities because of a concern that stimulants may further increase the risk of sudden death above the risk that is already present with such abnormalities," according to an FDA statement.
Daytrana use is also contraindicated in children who have significant anxiety, tension or agitation; allergies to methylphenidate or other Daytrana ingredients; glaucoma; Tourette syndrome or a family history of Tourette syndrome; or are currently taking a monoamine oxidase inhibitor (MAOI) or have discontinued a MAOI in the previous 14 days.
The product is manufactured by Noven Pharmaceuticals Inc. for Shire U.S. Inc.