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Daytrana Patch Linked to Permanent Skin Discoloration

No Longer Accepting Cases

June 25, 2015 — The Daytrana patch has been linked to over 50 cases of chemical leukoderma, a condition that causes permanent loss of skin color, according to a new Safety Warning from the FDA.

Daytrana is a patch that is applied to the patient’s hip for 9 hours per day, where is slowly delivers a potent stimulant drug called methylphenidate. It is used to treat symptoms of attention-deficit hyperactivity disorder (ADHD).

The FDA reviewed its database of adverse events and found 51 cases between April 2006 and December 2014. In seven cases, the loss of skin pigmentation occurred in areas where the patch was applied but also in other areas of the body. The time until symptoms appeared ranged from 2 months to 4 years.

According to the FDA:

“Permanent loss of skin color may occur with use of the Daytrana patch. … This skin condition, called chemical leukoderma, is not physically harmful, but it is disfiguring and not thought to be reversible so can cause emotional distress.”

This is not the first time Daytrana has been linked to skin problems. The Institute for Safe Medication Practices (ISMP) published a QuarterWatch (PDF) report in 2012 warning that up to 30% of children had skin redness, irritation, and discomfort after using Daytrana, compared to just 3-6% of children on a placebo.

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