Side effects include loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, fever and stunted growth. For those who have cardiac abnormalities, taking this class of pharmaceutical drug can cause sudden death. May cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis. The drugs are addictive and have a high potential for abuse.
Yet despite these dire warnings, the FDA has moved forward with making these pharmaceuticals more attractive to children, so that “the new, quick-dissolving formulation will help harried mothers get their kids medicated faster before school.” [source]
The drugs in question? Pharmaceutical grade amphetamines used for attention deficit hyperactivity disorder (ADHD).
The new drug on the block — and the one that has critics most worried — goes under the label Adzenys XR-ODT, an amphetamine similar to Adderall which dissolves on the tongue instead of being swallowed in pill form. It also tastes just like orange candy, earning it the dubious title “kiddie cocaine.”
To highlight how bizarre the situation really is, an Adzenys advertisement presents a laundry list of side-effects, requirements and contraindications:
Adzenys XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Adzenys XR-ODT in a safe place to prevent misuse and abuse. Selling or giving away Adzenys XR-ODT may harm others and is against the law.
Tell your doctor if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Adzenys XR-ODT is a stimulant medicine. Tell your doctor about health conditions, including if:
- You or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects, and sudden death, stroke and heart attack have happened in adults. Your doctor should check for heart problems prior to prescribing Adzenys XR-ODT and will check you or your child’s blood pressure and heart rate during treatment. Call the doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Adzenys XR-ODT.
- You or your child has mental problems, or a family history of suicide, bipolar illness, or depression. This is important because the following could occur: new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (hearing voices, believing things that are not true, are suspicious) or new manic symptoms.
- You or your child has circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking Adzenys XR-ODT.
- Your child is having slowing of growth (height and weight). Your child should have his or her height and weight checked often while taking Adzenys XR-ODT.
- You or your child has kidney problems.
Do not start any new medicine while taking Adzenys XR-ODT without talking to your doctor first.
Common side effects of Adzenys XR-ODT include:
- Decreased appetite and problems sleeping.
- Children 6 – 12 Years also include: Stomach pain, extreme mood change, vomiting, nervousness, nausea, and fever.
- Children 13 – 17 Years also include: Stomach pain and weight loss.
- Adults also include: Dry mouth, headache, weight loss, nausea, anxiety, restlessness, dizziness, fast heart beat, diarrhea, weakness, and urinary tract infections.
These are not all the possible side effects of Adzenys XR-ODT. Call your doctor for medical advice about side effects.
The above list makes one wonder if parents truly know what they are getting into by placing their child on pharmaceutical amphetamines.
Serious medical condition or normal childhood behavior?
Considering 11 percent of kids under 18 are diagnosed with ADHD, and sales for ADHD drugs last year reached $12.7 billion — up from $4.7 billion a decade ago — the classification of ADHD has come under scrutiny in recent years. Many feel doctors are immediately opting for pharmaceutical intervention when behavioral therapy, cleaning up the diet and reduced screen time is a more effective (and safe) route. Some believe ADHD is largely a sham, and that what the medical community is viewing as a disorder is actually normal childhood behavior rebelling against unreasonable modern poisons and constraints — such as additives and preservatives in food, heightened exposure to environmental toxins (including EMFs), sitting still for hours on end under fluorescent lighting and less time spent outdoors.
Marketing genius or potential mayhem?
As seen with prescription painkillers contributing to an uptick in heroin addiction, physicians are concerned the sweet-tasting, candy-like ADHD medication will also encourage addiction and illegal use.
Dr. Mukund Gnanadesikan, a child and adolescent psychiatrist in Napa, California, feels that presenting amphetamines in a temptingly sweet manner and convenient package is “a recipe for people to request it and then sell it.” He adds, “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.”
In spite of questions raised, the extended-release amphetamine was approved by the Food and Drug Administration last January for use in children six and older. Neos Therapeutics, who developed and markets the drug, intensified their commercial efforts last week to get “ahead of the back-to-school season,” said CEO Vipin Garg. The launch is now in full-swing.
Apparently, with 125 sales reps around the U.S., the company is having “no problem” selling the drug to physicians. Business is booming for ADHD drugs to begin with as 75 percent of children diagnosed with the condition are on medication. There’s also widespread misuse among teenagers and adults since the stimulants are often used as party drugs and for increasing performance — they’re especially popular among college students to help with focus and improve grades. It’s estimated that by 2020, ADHD drugs will grow to $17.5 billion in sales per year.
It’s no surprise the company is pushing Adzenys hard. After all, their stocks soared when the drug was formally approved by the FDA. “The Grand Prairie-based company’s stock traded as much as 67 percent higher and ended Thursday with a gain of $3.96 a share, or 42 percent, to close at $13.38,” reported the Dallas Morning News at the time.
Profits aside, the controversy surrounding Adzenys also involves the packaging — a blister pack, not a pill bottle — rendering the drug extremely convenient and portable, making it easier to ‘pop’ a tablet anytime, anywhere. For those who believe ADHD is excessively over-diagnosed, having Adzenys easily accessible and reminiscent of candy is disturbing.
“It’s a move that sanctions “an orally disintegrating amphetamine for kids by the morally disintegrating FDA,” said Dr. Alexander Papp, an adult psychiatrist affiliated with University of California, San Diego.
“What’s next?” Papp scoffed. “Gummy bears?”’ [Source]