“Kiddie Cocaine” – FDA Approves New ADHD Amphetamine Drug Disguised as Candy

Kiddie Cocaine - FDA Approves New ADHD Amphetamine Drug Disguised as Candy

3rd June 2016

By Carolanne Wright

Contributing writer for Wake Up World

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.

From the Adzenys XR-ODT website
Above: Promotional material from the Adzenys XR-ODT website.

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, wth 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]

Article sources

About the author:

Carolanne WrightCarolanne Wright enthusiastically believes if we want to see change in the world, we need to be the change. As a nutritionist, natural foods chef and wellness coach, Carolanne has encouraged others to embrace a healthy lifestyle of organic living, gratefulness and joyful orientation for over 15 years.

Through her website Thrive-Living.net, she looks forward to connecting with other like-minded people from around the world who share a similar vision. You can also follow Carolanne on Facebook, Twitter and Pinterest.

Further reading from Carolanne Wright:

 


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  • chuberry

    I wouldn’t get too shook up about that huge laundry list of potential side effects. By law, they have to disclose this stuff and they should. But then other folks will take this list and sensationalize it making it appear to be extremely hazardous when that’s not really the case.

    ALL medical drugs have such a list. If anyone bothered to read the side effect lists of over the counter meds for colds, headaches, PMS, and dozens of other conditions, you would get the idea that all meds are extremely dangerous. The thing is, we should take all drugs with caution. If you comply with the warnings and recommendations you’ll generally be ok.

    The real danger I see of this new ADHD form is that some kids will likely take multiple doses because it likely will taste really good. Instead, they should just sweeten it up enough so that it just doesn’t taste nasty!

    Now in my case, I was diagnosed with ADHD when I was 48 and have been medicated for it ever since. All four of my natural children also have ADHD. Medication helps the three of them that will take it. And they have become tremendously productive and successful in their lives in part, at least, due to the use of ADHD medication. When I forget to take mine, it doesn’t take long before family and friends start asking me if I’ve taken my morning meds. They ALWAYS know!

    My grandson also has ADHD. He had severe behavior issues prior to medication and is much better now. He takes the same med as I do, just a different dose. Straterra. Works differently than most ADHD drugs. It’s not a stimulant like many of them. Instead it seems to increase the amount of norepinephrine. This appears to help ADHD by increasing attention span and reducing impulsive behavior and hyperactivity.

    I like this drug because it is not very susceptible to misuse. No buzz or anything like that. You just have to start with a low dose and work your way up to an effective dose to avoid headaches. Nobody will want to take THIS stuff as a party drug! The headache you get by being an occasional user would be a party killer.

  • Debs

    Clueless with a capital C !!!!, There is something known as independent research , do a bit you might learn something. I suppose you have not heard about the failed chemo drug that masquerades as an antibiotic either ? . You know , the one that has devastated untold numbers of peoples lives including mine, where the horrendous ‘side effects ‘ have been buried for nigh on 30 years by Big Pharma , only now they are being forced to update the warning that the fluoroquinolone antibiotics are horrendously toxic & can cause irreversible permanent damage, something known as Fluoroquinolone associated disability ( FQAD ) or as we who have been seriously injured by them , have known it by for many years, Fluoroquinolone toxicity . in the FDA internal files was found via a freedom of information request information which showed that these so called ‘ antibiotics ‘ potentially cause mitochondrial toxicity, NOT information which was forwarded to Drs or patients .

    Look up a few reliable sites, where you can find studies on the various psychotropic drugs, make sure you look into the drugs prescribed for ‘ ADHD ‘, & exactly WHAT they are, & the potential long term risks of taking them ( research each ingredient ), research ‘ medication spellbinding ‘ . I suggest Psychiatrist Dr Peter Breggins site for starters ( who has been an expert witness in numerous trials related to damage caused by the various psychotropic drugs, & has had access to the documents, others have not seen ) . Research ‘ study 329 ‘ on Paxil, find out what was withheld there . Please understand that the RAW data on the ADRs from the clinical trials is withheld by Big Pharma, kept locked up out of reach from everyone INCLUDING our Drs, ONLY Big Pharma knows just how dangerous those Psychotropic drugs really are, & keep in mind at all times that due to being misinformed & taught ONLY by Big Pharma since the day they start medical school, that when it comes to the allopathic drugs our Drs are ignorant beyond belief & in fact know VERY little about the ‘ side effects ‘ of ANY allopathic drug they prescribe, psychotropic or otherwise.