Is Daytrana Worth the Side Effects?

New York, NYPatients who use Daytrana have been told to watch for Daytrana side effects, including discoloration of the skin. Skin discoloration, which is not dangerous but can be permanent, has been linked to the use of the Daytrana patch, used to treat attention deficit hyperactivity disorder (ADHD). According to the US Food and Drug Administration (FDA), 51 cases of skin color loss have been reported in connection with the Daytrana patch. But back in 2013, the Institute for Safe Medicine Practices (ISMP) was questioning the continued use of Daytrana, based on repeated recalls of the drug.

The FDA issued its Drug Safety Communication on June 24, 2015, noting that patients who were using the Daytrana patch (known generically as the methylphenidate transdermal system) for ADHD were at a risk for permanent loss of skin color. When the FDA made its announcement, it urged patients to watch for “new areas of lighter skin,” especially in regions directly underneath the patch. In addition to the loss of skin color, the FDA noted that patients may suffer emotional distress as a result of the disfiguring skin condition, known as chemical leukoderma.

According to the FDA, a review of the FDA Adverse Event Reporting System resulted in the discovery of 51 reports of chemical leukoderma linked to the Daytrana patches from April 2006 to December 2014. An additional case that had not been reported to the FDA but was published was also noted. Cases of leukoderma occurred anywhere from two months to four years after starting Daytrana treatment, with all cases of leukoderma being permanent.

Patients who are using the Daytrana patch are advised to not stop using the patch without consulting with their health care professional.

Even prior to this issue, Daytrana had faced serious concerns, according to CBS News (12/7/09). In fact, in 2009, Daytrana faced its eighth recall, following concerns patients could not remove the protective liner on the patch, although the patch’s maker said the problem was not a safety issue.

In its 2012-Q2 QuarterWatch report (1/9/13), the ISMP noted it had identified more than 1,000 cases of product problems linked to Daytrana, making it the most complained about drug reported on by the ISMP at that time. The most complained about issue with the patch was difficulty removing the protective liner. According to the ISMP, as of the writing of the newsletter, the patch had been recalled 12 times since 2006, all for issues with the protective liner.

“For the Daytrana methylphenidate patch, we cannot identify a clinical or safety advantage to justify its continued use,” the ISMP wrote.

Daytrana is made by Noven Therapeutics.