Daytrana, a brand name for methylphenidate, a patch used on children with ADHD, has recently come under scrutiny. The FDA released a Drug Safety Communication on the drug on June 24, 2015.
“The U.S. Food and Drug Administration (FDA) 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). FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma.”
In issuing the warning, the FDA stated that they had received 51 complaints in relation to the patch between April 2006 and December 2015. Skin color loss could be as large as 8 inches in diameter. Usually, the discoloration happens on the site where the patch was applied, although reports of problems on other parts of the body have also been received.
For parents of children with ADHD, this will come as a significant blow. Daytrana was marketed as the solution they had been waiting for, after all.
“It saves parents the hassle of crushing a tablet, mixing it with food, and hoping a child will swallow all of their ADHD medication. Your child can wear the once-a-day Daytrana patch when they need it and take it off when they don’t.”
Parents have now started to file lawsuits against Noven Pharmaceuticals, who markets the product. According to a case lawyer, most parents are not made aware enough about the warnings and potential side effects of the patch. Meanwhile, on the Daytrana website, the patch continues to be described as an innovative and revolutionary solution.
“Long lasting but not too long: The once-daily Daytrana patch is the only long-acting ADHD treatment that can be removed early to fit your child’s changing routine.”
In fact, Noven is said to be using highly emotive tactics in their advertising campaign. They use statements such as ‘pill-swallowing issues’ and ‘children come in different sizes’ to make themselves look more attractive and in touch with their market.
In reality, however, all pharmaceutical companies are simply competing to attract customers. This is why it is the consumers who have to be take responsibility for educating themselves about the risks. After all, the consumers will also be the ones suffering the long term consequences.
ADHD prevalence continues to rise, putting significant strain on physicians to come up with a treatment for the children they look after. For pharmaceutical companies, this epidemic is good news as it means they have a bigger market to peddle their wares to. ADHD medications, including methylphenidate, have existed for a long time and are now actually available as generic drugs. As a result, pharmaceutical companies have to come up with different tactics to attract their clientele.
The United States Center for Disease Control and Prevention (CDC) has released recent figures about the prevalence of ADHD.
“The American Psychiatric Association states in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) that 5% of children have ADHD. However, studies in the US have estimated higher rates in community samples. About half of preschoolers with ADHD were taking medication for ADHD, and about 1 in 4 were treated only with medication.”
To date, almost every drug for the treatment of ADHD that the FDA has approved are now generic. This means that manufacturers have to come with unique formulations that allow them to apply for a New Drug Application so that they can avoid generic competition for a longer period of time. This tactic is generally used by small, newly emerging pharmaceutical companies as it allows them to compete with the giants. However, they also have to get consumers on board.
The FDA initially approved Daytrana in April 2006.
“On April 6, The Food and Drug Administration approved Daytrana, the first transdermal (skin) patch, for treating Attention Deficit Hyperactivity Disorder (ADHD) in children six to 12 years of age. Daytrana is a once daily treatment containing the drug methylphenidate, a central nervous system (CNS) stimulant.”
The patch was mainly popularized by the clever marketing technique that showed it would make the lives of parents and their ADHD children so much easier. However, the drug has now been found to cause skin patches and various parents have started litigation against Noven because of this. It is now also apparent that concerns about this were first raised some two years ago after a letter was written to the editor of the Journal of the American Academy of Dermatology.
“A 2013 Letter to the Editor in Journal of the American Academy of Dermatology (6/12) recounted the experiences of a 16-year-old male who developed white patches on his hips shortly after using Daytrana. The letter’s authors recommended ‘close observation of treated patients to prevent chemical leukoderma.'”
Parents whose children have been prescribed Daytrana are advised to closely monitor their children and to seek immediate medical advice. The FDA has told them to not cease usage of the patch before having spoken to a medical professional about the best course of action. They are also encouraged to investigate their rights so that they know what possibilities are open to them should they notice any adverse reactions to the drug. To date, issues remain reasonably unheard of. However, now that the FDA has released an official safety warning, it is more than likely that people will start to come forward with their own stories, looking for help.