Daytrana ADHD Drug Patch Linked to Chemical Leukoderma

The U.S. Food and Drug Administration (FDA) is warning parents and caretakers of children and adolescents who use the Daytrana patch to treat Attention Deficit Hyperactivity Disorder (ADHD) to be on the lookout for signs of a skin condition known as chemical leukoderma, which can cause permanent loss of skin color.

On June 24, the agency said in a Safety Announcement on its website that parents and caregivers of individuals who use Daytrana should watch for new areas of lighter skin, especially under the drug patch, and immediately report these symptoms to a health care provider. Patients should not stop using Daytrana without talking to their health care provider. A doctor or health care provider may consider alternate treatments for patients who exhibit symptoms of chemical leukoderma.

Chemical leukoderma is caused by repeated exposure to specific chemical compounds. It is not a harmful condition, but it can cause permanent disfigurement. The FDA said it reviewed cases of chemical leukoderma associated with the Daytrana patch that were reported using the FDA Adverse Event Reporting System (FAERS) and described in the drug’s medical literature. The agency identified 51 FAERS cases from April 2006 to December 2014 and one published case that was not recorded in FAERS. Since FAERS only includes reports submitted to the FDA, more cases may exist.  Chemical leukoderma can cause areas of skin up to 8 inches in diameter to lose color. The condition is irreversible.

Based on reports received through FAERS, the onset of chemical leukoderma is anywhere from two months to four years. All the patients cited in the reports described a loss of skin color, primarily in the areas around where the patch was rotated. A few patients reported color changes on other parts of the body where the Daytrana patch was never applied. In all cases, the color changes were permanent.

Daytrana is part of a group of drugs known as central nervous system stimulants. The patch works by increasing attention and decreasing restlessness in children and adolescents who are overactive, can’t concentrate for very long, or are easily distracted or impulsive, according to the Safety Announcement. The patch is applied to the hip area and delivers medication through the skin into the bloodstream. In addition to chemical leukoderma, Daytrana may also cause increased blood pressure and heart rate, nausea, decreased appetite and weight, aggressive behavior, anger and irritability.

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