FDA Concerned About Daytrana Side Effects

Washington, DCThe US Food and Drug Administration (FDA) has issued a warning that Daytrana side effects could include a risk of permanent skin disfiguration. The warning came in June 2015, when the FDA said it had received 51 cases of chemical leukoderma - changing of skin color - in the past eight years.

Daytrana is a skin patch used to treat attention deficit hyperactivity disorder in children and adolescents by increasing attention and decreasing restlessness. According to the FDA, it is applied to the patient’s hip on the skin once daily and left on for nine hours. On June 24, 2015, the FDA announced a new warning to Daytrana’s label concerning the risk of permanent loss of skin color, also called chemical leukoderma. The FDA warned patients and caregivers to watch for lighter skin - especially in the area directly under the patch - and alert health care professionals of any skin color changes.

Chemical leukoderma is linked to exposure to certain chemicals. Although chemical leukoderma is not harmful or life-threatening, it is believed to be permanently disfiguring, which can also cause emotional distress. It can arise any time from within months of first exposure to years of exposure.

“FDA identified 51 FAERS [FDA Adverse Event Reporting System] cases from April 2006 to December 2014 and one published case that was not recorded in FAERS,” the agency warned. It also noted that because FAERS only includes reports made to the FDA, there are likely more cases of chemical leukoderma linked to Daytrana that have not been reported. Most cases involved a loss of skin color around the area the patch was applied, but in some cases the skin color change occurred on places that were not exposed to the patch. All reported cases of chemical leukoderma were permanent.

The FDA advised patients not to stop using Daytrana without talking to their medical provider. The agency also advised patients to rotate the patch’s application site if possible.

A 2013 Letter to the Editor in Journal of the American Academy of Dermatology (6/12) recounted the experiences of a 16-year-old male who developed white patches on his hips shortly after using Daytrana. The letter’s authors recommended “close observation of treated patients to prevent chemical leukoderma.”

Lawyers are investigating whether patients were adequately warned about the risk of chemical leukoderma before using Daytrana.