Concerns Raised Over Reported Daytrana Side Effects

Washington, DCParents constantly have to make decisions about the health and well-being of their children, and sometimes those decisions involve medications that are supposed to help their children. One such medication is the Daytrana patch, which has come under scrutiny for reportedly causing a permanent loss of skin color. Of course, when parents make decisions about the best medications for their children, they do so hoping they have the best information available. Problems arise, however, when the information they have isn’t as reliable as it could be.

Back in 2014, Shire agreed to pay almost $60 million to regulators to settle allegations that the company made unsubstantiated claims about the effectiveness of a variety of its drugs, including Daytrana. Although the company admitted no wrongdoing, the Department of Justice alleged Shire marketed Daytrana as being less likely to be abused than Adderall, another drug designed to treat attention deficit hyperactivity disorder (ADHD).

According to the Boston Business Journal (9/25/14), Shire agreed to pay $56.5 million to various federal and state governments and another $2.9 million to Louisiana, to settle a civil complaint. There is no word on whether parents chose to use Daytrana because of the claim that it was less likely to be abused than Adderall.

Since that time, the US Food and Drug Administration (FDA) has issued a warning regarding the use of Daytrana. In June 2015, the FDA warned that the use of Daytrana could potentially cause chemical leukoderma - a permanent loss of skin color.

“Chemical leukoderma is a skin condition that causes the skin to lose color due to repeated exposure to specific chemical compounds,” the FDA wrote. “The condition is not physically harmful, but it is disfiguring.” In addition to being permanent, the FDA noted that the change in skin color could cause emotional distress in patients.

The FDA’s warning came after an analysis of the FDA’s Adverse Event Reporting System (FAERS) database, which found 51 cases of chemical leukoderma reported to the FDA from April 2006 to December 2014, and one published case not included in FAERS. The FDA noted that onset of the chemical leukoderma could occur from two months to four years after starting Daytrana treatment, and some patients reported a change in skin color in areas where the patch was not applied. All cases reported the skin color change was permanent.

Daytrana is designed to treat ADHD by increasing attention and decreasing restlessness. Patients who are using Daytrana should not stop using the patch without first talking to their health care professional.