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Side effects of Daytrana, a skin patch prescribed for treatment of attention deficit and hyperactivity disorder (ADHD), may cause users to suffer permanent skin pigmentation changes, known as chemical leukoderma.
STATUS OF DAYTRANA CHEMICAL LEUKODERMA LAWSUITS: Product liability lawyers are reviewing potential Daytrana patch lawsuits for users diagnosed with chemical leukoderma, including both adults and children who have suffered skin color changes or scarring. As a result of the manufacturer’s failure to adequately warn about the risk of Daytrana skin problems, financial compensation may be available.
MANUFACTURER: Noven Pharmaceuticals, originally developed by Shire.
OVERVIEW: The Daytrana patch (methylphenidate transdermal system) was originally approved by the FDA for treatment of ADHD in 2006. It is applied once-daily, delivering medication through the skin.
The ADHD patch is designed to release methylphenidate into the patient’s body over time, often prescribed for both children and adults. The drug is a stimulant commonly used to treat ADHD, and is the active ingredient in Concerta and Ritalin. It increases activity in the central nervous system. It is often used off-label for bipolar and depression.
Problems with Daytrana patch surfaced shortly after the drug was introduced, with the original developer, Shire, giving up on the patch in 2010, following at least 10 recalls in just four years on the market. Noven then took over, and has issued at least two additional Daytrana recalls.
Most of the problems, and recalls have been linked to the adhesive backing, which either caused the patch to fall off or led to problems with the patch being used on children properly.
In June 2015, the FDA required new warnings about the potential risk of chemical leukoderma, indicating that many users have experienced problems involving permanent loss of skin color on Daytrana.
DAYTRANA SKIN PATCH SIDE EFFECTS: Following use of Daytrana, users may experience side effects where patches of skin begin to change color, resulting in light or white patches. Known as chemical leukoderma, this causes the skin pigment cells to either die or cease functioning, often resulting in permanent scarring or disfiguration.
The FDA issued a drug safety communication in June 2015, announcing that new Daytrana skin patch warnings will be required.
Problems with chemical leukoderma on Daytrana have surfaced anywhere between 2 months and 4 years after first use of the skin patch, often developing at the location where the patch was applied and rotated. However, reports suggest that some users may experience skin color changes in different areas of the body where the patch was never used.
While the condition is not physically harmful, but it is disfiguring and can cause severe emotional distress. The areas of skin color loss may be up to 8 inches in diameter, and are often visible and prominent, causing embarrassment.
FAILURE TO WARN LAWSUITS OVER DAYTRANA AND CHEMICAL LEUKODERMA: As a result of Noven’s failure to thoroughly research the Daytrana patch or adequately warn users, the medical community, or parents, financial compensation may be available through a Daytrana patch lawsuit.
If warnings and information about the risk of permanent disfigurement from the Daytrana patch were provided, many users or parents would have chosen to use another medication for the treatment of ADHD, and some Daytrana patch skin discoloration incidents could have been avoided.