Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes

[Posted 06/24/2015]

AUDIENCE: Dermatology, Psychiatry, Pharmacy

ISSUE: FDA is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. See the FDA Drug Safety Communication for photos of chemical leukoderma.

Chemical leukoderma is a skin condition that causes the skin to lose color due to repeated exposure to specific chemical compounds. The condition is not physically harmful, but it is disfiguring. The areas of skin color loss described with the Daytrana patch ranged up to 8 inches in diameter. This condition is not thought to be reversible, which may cause emotional distress.

BACKGROUND: The Daytrana patch treats ADHD by working to increase attention and decrease restlessness in children and adolescents who are overactive, cannot concentrate for very long, or are easily distracted and impulsive.

RECOMMENDATION: Patients or their caregivers should watch for new areas of lighter skin, especially under the drug patch, and immediately report these changes to their health care professionals. Patients should not stop using the Daytrana patch without first talking to their health care professionals. FDA recommends that health care professionals consider alternative treatments for patients who experience these skin color changes.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178