If your child has Attention-Deficit/Hyperactivity Disorder (“ADHD”), then you might already be familiar with the Daytrana® (Methylphenidate) Patch. If so, you may want to think twice before brashly indulging because you may be putting your child’s livelihood at risk. On June 24, 2015, the FDA issued a Drug Safety Communication, warning that use of the Daytrana® patch may result in permanent loss of skin color/pigmentation, a condition known as chemical leukoderma. The FDA communication cited 51 adverse event reports of chemical leukoderma in patients using Daytrana® from April 2006 through December 2014, and further described reported areas of skin color loss as ranging up to 8 inches in diameter. In most cases, the loss of skin color was limited to the areas around where the patch was rotated; however, a small number of patients also reported skin color changes on other remote parts of the body.
The patch has been touted as something that would finally end parents’ daily struggle with ensuring their child complies with their medication routine and it “saves parents the hassle of crushing a tablet, mixing it with food, and hoping a child will swallow all of their ADHD medication”. Instead, simply slap-on a patch – “Your child can wear the once-a-day Daytrana® patch when they need it and take it off when they don’t.” This over-emphasis on convenience concerns Levin Papantonio trial attorney Virginia Buchanan, who explains, “Parents and doctors need to focus just as much on the warnings and side-effects as on the possible benefits of this method of drug delivery to young children.”
Noven Pharmaceuticals’ website for Daytrana® showcases the seemingly innovative product and gauges parents’ interests, stating that “The once-daily Daytrana® patch is the only long-acting ADHD treatment that can be removed early to fit your child’s changing routine.” The flamboyant website even provides a side-by-side comparison chart to support Noven’s supposition of superiority and convenience of Daytrana® over other existing oral ADHD medications. Craftily aligned with the focus of their advertising, Noven’s chart casts a shadow on its competitors’ mundane and apparently frustrating pills, enlightening us “pill-swallowing issues can be challenging” and “ADHD pills don’t offer the same flexibility as the patch.” Noven even ventures to stimulate a sense of safety and comfort in parents who may be apprehensive, using persuasive and endearing statements like “Children come in different sizes. Daytrana® does, too.”
But as pharmaceutical companies like Noven compete to attract consumers to new, high-priced versions of the same old drugs, parents must remain vigilant by educating themselves of the true risks and benefits associated with medications. The quality of life and future of an innocent child must always remain a priority, as it is they who may ultimately pay the price in the long run.
As ADHD becomes more prevalent among America’s youth, parents and physicians are under pressure to assess and implement appropriate, optimal therapeutic treatment for children under their care. Growing numbers of annual ADHD diagnoses means there is also a growing patient population that will almost certainly require pharmaceutical treatment at some time. Pharmaceutical corporations instinctively view this epidemic as an opportunity to capitalize on the ADHD consumer market, prompting them to explore innovative methodologies which might enable them to expand their share of the already giant ADHD-medication market. But methylphenidate and other ADHD medications are nothing new to the pharmaceutical industry, and almost all ADHD drugs on the market are now available in generic formulations.
According to the United States Center for Disease Control and Prevention (“CDC”), diagnosis of ADHD in children aged 4 to 17 years rose from approximately 8% in 2003 to 11% in 2011. In December 2013, the CDC published the 10th series of their Vital and Health Statistics publication Summary Health Statistics for U.S. Children: National Health Interview Survey, 2012. Among the data published in the summary report, over 5.8 million children in the U.S. aged 3 – 17 years were recognized as having ADHD in 2012.
Because nearly all ADHD therapeutics approved for use by the Food and Drug Administration (“FDA”) have become generic, the only way for a drug manufacturer to penetrate or expand their share of the ADHD medication market is to develop unique formulations that will allow them to apply for FDA approval under a New Drug Application (“NDA”), which provides them market exclusivity under the Federal Food, Drug, and Cosmetic Act and affords them protection from generic competition for a period of time. With this approach, newer or smaller drug companies can emerge among existing pharmaceutical giants by utilizing creative techniques to invent and market new forms of the same old drugs. And in order to compete with far-more affordable generic drugs while still managing to generate healthy profits, manufacturers must be able to gain mass market appeal and compel consumers to purchase these novel formulations – despite their considerably higher price.
Noven Pharmaceuticals, Inc. got Daytrana® initially approved for use by the FDA in April 2006. Noven Pharmaceuticals, Inc. a/k/a Noven Therapeutics, LLC, is headquartered in Miami, Florida. The Daytrana® patch is a transdermal system which supplies methylphenidate, the same active chemical in the blockbuster drugs Ritalin® and Concerta®, through the skin for up to 9 hours by way of Noven’s patented “DOT Matrix Technology”. The long-term impact of this technology on children remains to be seen.
The patch has also been touted as something that would finally end parents’ daily struggle with ensuring their child complies with their medication routine and it “saves parents the hassle of crushing a tablet, mixing it with food, and hoping a child will swallow all of their ADHD medication”. Instead, simply slap-on a patch – “Your child can wear the once-a-day Daytrana® patch when they need it and take it off when they don’t.”
But as pharmaceutical companies like Noven compete to attract consumers to new, high-priced versions of the same old drugs, parents must remain vigilant by educating themselves of the true risks and benefits associated with medications. The quality of life and future of an innocent child must always remain a priority, as it is they who may ultimately pay the price in the long run.
The Journal of the American Academy of Dermatology defines chemical leukoderma as “chemically-induced acquired hypopigmented dermatosis”. Simply put, chemical leukoderma is a condition characterized by patches of skin that have become permanently discolored due to epidermal melanocyte destruction as a result of applying certain chemicals to the skin. Chemical leukoderma is visually similar to the more commonly-known condition, vitiligo, but has a single distinguishable diagnostic factor: Repeated exposure to a known or suspected depigmenting agent – in this case, allegedly the Daytrana® patch.
Chemical leukoderma is considered a permanent epidermal disfigurement and at this time, has no known remedy. The onset of chemical leukoderma can range from 2 months to 4 years following initial use of Daytrana®, and there are no reports of depigmentation resolution following drug discontinuation. It is incumbent upon parents and physicians to disallow themselves to be seduced by clever messages conveyed by pharmaceutical corporations, and always mind the primacy of a child’s safety and wellbeing. Is risking permanent disfigurement to a child worth achieving some purportedly greater convenience?