Did ADHD Drug Skin Color Loss Show Up in Clinical Trials?

Washington, DCAnyone who has suffered the disfigurement to the skin that stems from Daytrana side effects would be forgiven for wondering why Daytrana skin color loss was not picked up in whichever clinical trials would have been performed before the Daytrana skin patch was approved.

Daytrana is a dermal patch prescribed to be worn on the hip and is used to treat symptoms of ADHD. Methylphenidate (Daytrana) is absorbed through the skin, a medically proven pathway for the delivery of some medications, such as birth control and medication to treat chronic pain. For many sufferers of ADHD, the Daytrana patch has been found to be a preferred method of treatment over oral medications, especially for children.

For treatment of symptoms related to ADHD, Daytrana appeared to be quite effective.

That optimism was dashed on June 25, 2015, when a communiqué was issued by the US Food and Drug Administration (FDA) with regard to Daytrana skin color loss. The regulator reported 51 cases of chemical leukoderma - skin discoloration - between April 2006 and December 2014.

The FDA did not identify if Daytrana side effects had been noted in testing and clinical trials leading up to the approval of Daytrana for the treatment of ADHD. However, chemical leukoderma is thought to be caused by repeated exposure to certain chemicals.

The FDA recommends that anyone using the Daytrana patch rotate the patch to a different location of the hip with each daily application, in order to avoid exposing the same patch of skin to methylphenidate. In fact, the official FDA-approved prescribing information and Official Medication Guide recommends that the patch be applied to a different area of the hip each time, and that the patch should not be worn for longer than nine hours.

Skin reactions are listed as the most common Daytrana side effects. “The most common side effects of Daytrana include skin problems where you apply Daytrana (redness, small bumps, itching),” the Medication Guide states.

There does not appear to be any reference to chemical leukoderma or the possibility thereof. Six weeks after the FDA issued its warning on June 25, the Daytrana Medication Guide had yet to be updated.

The FDA pointed out that chemical leukoderma is disfiguring, but does not pose a risk to a patient’s health. The FDA did not specify the area or areas of health to which it referred.

Daytrana skin color loss is likely permanent. It also can show up in areas not necessarily associated with the Daytrana Patch application site. Some reports have suggested, according to the FDA, irreversible skin discoloration could reach up to eight inches in diameter.

While some discolorations are reported to have occurred within two months of using the Daytrana patch, other cases of chemical leukoderma have occurred after four years of use.

Chemical leukoderma is considered irreversible.

Daytrana is manufactured by Noven Pharmaceuticals Inc.