US FDA warning on Daytrana patch

The US Food and Drug Administration is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for attention-deficit hyperactivity disorder (ADHD), which is marketed by Noven Therapeutics, a subsidiary of Japanese drugmaker Hisamitsu Pharmaceutical (TYO: 4530)..

The FDA yesterday added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. Chemical leukoderma is a skin condition that causes the skin to lose color due to repeated exposure to specific chemical compounds. The condition is not physically harmful, but it is disfiguring. The areas of skin color loss described with the Daytrana patch ranged up to 8 inches in diameter. This condition is not thought to be reversible, which may cause emotional distress.

The Daytrana patch treats ADHD by working to increase attention and decrease restlessness in children and adolescents who are overactive, cannot concentrate for very long, or are easily distracted and impulsive.