The Food and Drug Administration (FDA) has added a new warning to the labeling of methylphenidate transdermal system (Daytrana), a patch used to treat attention deficit-hyperactivity disorder (ADHD). Areas of lighter skin (chemical leukoderma) have appeared after the start of treatment with the methylphenidate patch. Most have occurred near where the transdermal patch was applied repeatedly, anytime from two months to four years after the start of therapy. In a few patients, leukoderma occurred in places where the patch was not applied. The loss of skin color appears to be permanent and affected areas have been as large as 8 in. This new warning comes after the FDA reviewed 52 reports involving the patch (51 in the FDA Adverse Event Reporting System database that it received between April 2006, when the drug was first approved, and December 2014, and one in the medical literature).

Methylphenidate is a central nervous system stimulant that increases attention span and decreases restlessness in children and adolescents with ADHD. The transdermal patch is applied in the hip area daily and worn for nine hours. Oral forms of methylphenidate include Concerta and Aptensio XR. (Concerta has been associated with skin rash, sometimes severe, and exfoliative dermatitis; Aptensio has been associated with alterations in skin color on the fingers and toes, from a loss of color to changes to blue or red.)

Approximately 109,000 prescriptions for Daytrana patch were filled in 2014. The risk of chemical leukoderma appears to be small, but nurses should nevertheless inform patients and their families of this slight risk. They should instruct the family to notify the prescriber if they notice a loss of pigmentation in the patient's skin. NPs who prescribe the patch should instruct the patient to discontinue the drug if the patient experiences loss of pigmentation and consider other long-acting treatments for ADHD. The nurse should encourage the patient and family to read the medication guide that comes with each filled prescription. It will have the most up-to-date information on possible adverse effects. If a patient does experience chemical leukoderma or any other adverse effects after beginning therapy with the methylphenidate patch, the nurse should report the adverse events to the FDA MedWatch program at http://www.fda.gov/medwatch.

To read the FDA Drug Safety Communication regarding the new warning, as well as to view photos of the skin discoloration seen with use of this drug, go to http://1.usa.gov/1Nbkht1.