Methylphenidate Transdermal System May Cause Chemical Leukoderma, Warns FDA

ROCKVILLE, Md -- June 24, 2015 -- The US Food and Drug Administration (FDA) is warning that chemical leukoderma may occur with use of the methylphenidate transdermal system (Daytrana patch) for attention-deficit/hyperactivity disorder (ADHD).

The FDA added a new warning to the drug label to describe this skin condition. Chemical leukoderma is not physically harmful, but it is disfiguring. The areas of skin colour loss described with the methylphenidate patch ranged up to 8 inches in diameter. This condition is not thought to be reversible, which may cause emotional distress.

Patients or their caregivers should watch for new areas of lighter skin, especially under the drug patch, and immediately report these changes to their healthcare professionals. Patients should not stop using the patch without first talking to their healthcare professionals.

The FDA recommends that healthcare professionals consider alternative treatments for patients who experience these skin colour changes.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: or call 1-800-332-1088, or submit by fax to 1-800-FDA-0178.

SOURCE: US Food and Drug Administration
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