In a shocking decision, the US Food and Drug Administration has approved a candy-flavored amphetamine-based medication ADZENYS XR-ODT (an orally disintegrating tablet) for treating Attention Deficit Hyperactivity Disorder (ADHD) in children six years and older.
The extended release chewable drug is therapeutically equivalent to Adderall XR – which is identical to meth – and its side effects include loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. When the FDA deemed the central nervous system (CNS) stimulant safe in January, it warned:
1. CNS stimulants, including ADZENYS XR-ODT, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence.
2. CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
3. CNS stimulants may induce a mixed or manic episode in patients with bipolar disorder.
4. CNS stimulants, at recommended doses, may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in patients without prior history of psychotic illness or mania.
5. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.
6. Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems.
7. Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon.
A drug which can cause heart attack is being prescribed to treat kids. Seriously?
Vipin Garg, CEO of Neos Therapeutics, the Dallas-based pharmaceutical company behind ADZENYS XR-ODT, is naturally optimistic:
“We look forward to offering patients, their parents and caregivers with this new treatment option ahead of the back-to-school season this summer, and expanding our focus into newly diagnosed pediatric patients and adolescent and adult patients.”
Nonetheless, a tastier, quick dissolving, and more convenient form of meth, available in six different dosage strengths, is already stirring controversy. Dr. Mukund Gnanadesikan, a child and adolescent psychiatrist, cautioned:
“Presenting amphetamines in a tasty, convenient package is a recipe for people to request it and then sell it. I’m not a big fan of controlled substances that come in forms that can be easily abused — and certainly a chewable drug falls into that category.”
For Dr. Alexander Papp, an adult psychiatrist affiliated with University of California, ADHD is wildly over diagnosed and over medicated and the idea of making a drug more tasty and convenient is jarring.
“It’s a move that sanctions an orally disintegrating amphetamine for kids by the morally disintegrating FDA. What’s next? Gummy bears?”
— Patty Powers (@sobercoachnyc) June 2, 2016
ADHD is a condition with symptoms such as poor concentration, hyperactivity and learning difficulties. According to the National Institute of Mental Health, the disorder every year affects about 4.1% of American adults aged 18 years and older, and 9% of children aged 13-18 years.
According to a report from market research firm IBISWorld, sales for ADHD medications were at $4.7 billion in 2006, had nearly tripled to $12.7 billion by 2015, and are projected to grow to $17.5 billion by 2020.
Much of the increase in ADHD diagnoses and treatment can be attributed to aggressive marketing efforts from pharmaceutical companies like Neos Therapeutics. The New York Times reported in 2013:
“The rise of ADHD diagnoses and prescriptions for stimulants over the years coincided with a remarkably successful two-decade campaign by pharmaceutical companies to publicize the syndrome and promote the pills to doctors, educators and parents. With the children’s market booming, the industry is now employing similar marketing techniques as it focuses on adult ADHD, which could become even more profitable.”