Problems with Daytrana Skin Color Patch Date Back Years

Washington, DCSide effects involving Daytrana skin color loss isn’t the only problem the Daytrana ADHD patch has encountered over its history. In fact, while the US Food and Drug Administration (FDA) was busy compiling adverse event reports involving loss of skin pigmentation associated with the patch application, the makers and marketers of Daytrana were having other problems, prompting some critics to call for a ban of the product.

The Daytrana patch is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents 6 through 17 years of age, and is a transdermal patch designed to be applied to the skin for the dispensation of medication in a controlled fashion through the dermis. Various plaintiffs having filed complaints with their Daytrana attorney have found that skin has become discolored at the application site - often finding that pigmentation is not restored when the patch is removed. The adverse event, known as chemical leukoderma, has been monitored by the FDA since 2006, the year at which Daytrana first appeared on the market. The federal regulator has since mandated the manufacturers of Daytrana to include a warning on the label for methylphenidate (Daytrana) for loss of skin color that could become permanent.

While the manufacturer warns against placing the Daytrana patch on the same application site in an effort to avoid leukoderma, some plaintiffs have found that skin color loss occurs on areas of the skin where the patch has not been applied.

Back in 2009, while the FDA was in the midst of compiling what would become 51 reports of Daytrana skin color loss between April 2006 and December 2014, a columnist with CBS News Moneywatch was decrying the deficiencies of the Daytrana patch. Jim Edwards, writing for Moneywatch on December 7, 2009, noted that the Daytrana patch had been recalled due to the inability for some patients to remove the liner on the back of the patch.

There was no mention of Daytrana skin color loss at the time. However, Edwards noted that the December 2009 voluntary recall by Shire plc (Shire) and Noven Pharmaceuticals Inc. (Noven) was the eighth recall of the Daytrana patch.

Edwards did not pull any punches. He wrote in 2009 that the “Daytrana ADHD patch does not work, never has done, and should be quietly ditched by Shire and Noven before the FDA wakes up…”

At the time of the voluntary recall, Shire is reported as having taken the action because some patches failed to meet presently - or at some future time - specifications for removal of the liner, posing difficulty for some patients. The recall was not considered a safety issue.

The current debate over Daytrana side effects involving discoloration of skin might be interpreted as a cosmetic issue. But certainly, a serious adverse reaction nonetheless depending upon where the discoloration occurred and whether or not the Daytrana skin color loss turned out to be permanent.

According to a press release issued by Noven and dated October 1, 2010, Daytrana was originally licensed globally to Shire by Noven in 2003. Daytrana acquired FDA approval and was launched onto the US market in 2006. In October 2010, Noven secured from Shire all global rights to Daytrana, a product Noven originally developed and manufactures.

Plaintiffs continue to file Daytrana side effects lawsuits over skin color loss.