News Brief for September 2015

FDA Warns of Permanent Skin Color Changes With Methylphenidate Skin Patch (DAYTRANA)

On June 24, 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 the methylphenidate transdermal system (DAYTRANA; known as the methylphenidate patch).[1] The methylphenidate patch is approved for treatment of attention-deficit hyperactivity disorder. From 2006 to 2014, the FDA received reports of 51 cases of the skin condition, known as 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. These changes began as early as two months and as late as four years after starting the patch. Chemical leukoderma caused by the methylphenidate patch unfortunately appears to be irreversible.

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.

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. Accessed June 29, 2015.