Product News and Recalls

Daytrana ADHD Patch Can Cause Permanent Skin Color Loss, FDA Says

fda alerts on daytranaThe U.S. Food and Drug Administration (FDA) has released a safety communication warning that the Daytrana patch, used to treat attention deficit hyperactivity disorder (ADHD), can result in permanent loss of skin color.

The Daytrana methylphenidate transdermal system is a prescription patch marketed by Noven Pharmaceuticals for use in treating ADHD. It is supposed to increase attention and decrease distractedness in overactive children and adolescents. The manufacturer directs patients to wear the patch on skin around the hip for nine hours a day, and suggests rotating where the patch is placed on a regular basis. According to FDA data, roughly 109,000 patients received Daytona patch prescriptions from U.S. outpatient retail pharmacies in 2014.

The FDA reviewed their adverse event reporting database and identified 51 cases from April 2006 to December 2014 involving chemical leukoderma, or permanent loss of skin color. In the majority of cases, skin color loss occurred at sites where the patch had been applied. However, in a few patients, loss of skin color was observed in other areas. The agency notes that in all cases, the loss of skin color was permanent. Areas where skin color was lost ranged up to eight inches in diameter. While not physically dangerous, leukoderma is a disfiguring condition that can cause emotional and mental distress in those afflicted.

The FDA has advised caregivers and patients of the Daytrana patch to look out for areas of lighter skin, especially at the site of application, and to report any discoloration to a health care professional. The agency says patients should not stop using the Daytrana patch without first consulting a professional.

Manufacturers of drugs and medical devices are responsible for knowing of and warning about the health risks their products may pose. If you or someone you know experienced permanent loss of skin color after using the Daytrana patch, contact the lawyers at Lopez McHugh for a free consultation. You may be eligible for legal compensation.