FDA Warns AD/HD Patch Can Lead To Permanent Skin Color Loss

Medscape (6/25, Brooks) report that the FDA issued a warning Wednesday that Noven Therapeutics, Inc.’s Daytrana (methylphenidate), a patch for the treatment of attention-deficit/hyperactivity disorder (AD/HD), “may cause permanent skin color loss.” According to the FDA, “postmarketing reports of acquired skin depigmentation or hypopigmentation of the skin, consistent with chemical leukoderma, have been associated with the use of the Daytrana patch.” The condition is not physically harmful, but it is disfiguring. In response, the FDA “has added a new warning to the drug label to indicate the risk for chemical leukoderma.”

The Pharmacy Times (6/25, Allikas) reports that there have been 51 “chemical leukoderma cases reported to the FDA Adverse Event Reporting System (FAERS).” Healio (6/25) also covers the story.