FDA Approves Potentially Addictive ADHD Drug For Kids — In Candy Form

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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?”

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.”


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12 COMMENTS

  1. The fda says alot of drugs are ok to take even when they are aware of how bad they really are for us, I’m not sure who pays them off to do it, but it’s obvious they don’t protect us.

  2. Do any of the people wtiting this post have ADHD/ADHD? If theycdid, they would discover that children and adults are caller and able to focus netter, because Adderall produces a counter-effect to those with the disorder.

    A normal person would feel it as a stimulant. If it acts as one on any person diagnosed with ADD/ADHD, then they either do not have the illness or were prescribed too high of a dose.

    For those with this disorder, it makes learning in school and sitting still possible. For adults it can mean being able to not only hold a job or position, but to excell in one. It changed my life.

    • How about eating right to prevent ADHD? I was working with a cook that was in a study of these things here in Scandinavia. They found that 98 out of 100 people with ADHD got well after 1Y of trials with the right diet they prepared for each of them, they were different kind of foods to suit the person. I understood that this was a big deal.

      • I was on the meds for ADD and I felt like a zombie and would have crazy mood swings. I don’t care if it made me do better in school or would “help” with my job nothing is worth the downs I had.

  3. This article lost me with erroneous statement: “…ADDERALL XR, which is identical to Meth…”. You clearly know nothing about Pharmacology.

  4. What’s so crazy about this is, aside for giving an addictive drug to a child, that studies have shown that kids with ADHD IMPROVE DRAMATICALLY when refined sugar, chemicals and junk food are removed from people’s diets. So maybe instead of giving a child meth (!!), doctors should be teaching parents and children about only eating organic whole foods. The paradoxical effect of meth is a ridiculous argument when you could just be taking soda, potato chips, fast food, candy and over processed food that has lots of toxic pesticides and herbicides out of their diet. Learn to cook and the problem can be properly healed rather than putting a band aid on the problem which does nothing but mask the underlying issues and gives children an addictive drug!! What a joke. It proves once again that the FDA is literally owned by the pharmaceutical industry and people need to stop blindly following their ‘guidelines’.

  5. Adderal is not meth.

    Amphetamine, and dextroamphetamine, are not even close to methamphetamine.

    Thats like saying isoproyl alcohol is the same as beer, just because they both contain alcohol.

    I love anonymous, but you guys are spreading misinformation. Dont be like Fox news.

    • Adderal gives you almost the same kind of high, and it’s also addictive. This is why many kids I knew in high school sold their adderal on the streets.

  6. We eat organic and unprocessed food in my house, yet my youngest still has ADHD. He couldn’t focus well enough, even in a home school environment, too learn to read until he was seven years of age. SEVEN. Guess how old he was when we decided to follow the therapist’s advice and medicate him. Guess how long it took him to start reading after medication. The answers are seven and one month, respectively. The condition is real, the stimulants help, and please stop perpetuating misinformation via clickbait.

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