FDA WARNS OF PERMANENT SKIN COLOR CHANGES WITH METHYLPHENIDATE SKIN PATCH (DAYTRANA)

July 6, 2015

Here’s an important alert for patients (or their caregivers) using the methylphenidate patch (DAYTRANA).

On June 24, 2015, the Food and Drug Administration (FDA) issued a safety communication warning the public about permanent, disfiguring loss of skin color that can occur with use of methylphenidate transdermal system (known as the methylphenidate patch).[1] The skin condition is known as chemical leukoderma, which is caused by repeated exposure to specific chemicals.

The methylphenidate patch is approved for treatment of attention-deficit hyperactivity disorder (ADHD). The drug patch is supposed to be applied to the skin on the hip once daily for nine hours.

From 2006 to 2014, the FDA received reports of 51 cases of chemical leukoderma in patients using the methylphenidate patch and learned of one additional case reported in a medical journal. In 43 of the 51 cases reported to the FDA, loss of skin color occurred only in the skin areas where the patches were placed. In seven other cases, skin color loss also occurred at other skin sites. (The FDA could not determine the location in the remaining case.) The area of skin affected ranged up to 8 inches in diameter. The skin condition appeared two months to four years after starting the patch.

Chemical leukoderma caused by the methylphenidate patch unfortunately appears to be irreversible, which may result in emotional distress. The FDA noted that only three of the 51 affected patients reported to the agency had slight improvement in the skin condition with treatment, but no patient experienced a complete return to normal skin color after stopping use of the patch.

What you can do

• If you or a loved one is using the methylphenidate patch, monitor the skin for lighter-colored areas, especially in areas where the patch has been placed. If you notice any changes in skin color on any part of the body, contact your health care provider immediately.
• Do not stop using the methylphenidate patch without first talking to your health care provider.
• If you wish to avoid the risk of developing chemical leukoderma due to the methylphenidate patch, talk with your doctor about available oral medications approved for ADHD treatment.
• If you or a loved one experiences loss of skin color while using the methylphenidate patch, report it to the FDA MedWatch program at http://www.fda.gov/medwatch.

To see the FDA safety communication, visit the following link: http://www.fda.gov/Drugs/DrugSafety/ucm452244.htm. To see pictures of the skin changes that have been caused by the methylphenidate patch, click on “Photos of Chemical Leukoderma” near the bottom of the FDA safety communication.

References

[1] Food and Drug Administration. FDA drug safety communication: FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal system) for treating ADHD. June 24, 2015. http://www.fda.gov/Drugs/DrugSafety/ucm452244.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed June 29, 2015.