You must be 21 years old and above to access RxLeaf
Top

CBD Medicine Taken Off Schedule I!! But Only For Big Pharma

Jennifer Grant
dea

Can you imagine a world where real medicine is illegal except when it’s packaged and sold as an extract from Big Pharma? The DEA and FDA certainly can.

It’s been about three months since the anti-seizure, cannabis-derived pharma product, Epidiolex, gained approval for market. And today the DEA — with the approval of the FDA — is declaring that pharma CBD is now off Schedule I. The DEA document states that “this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent THC in Schedule V.”

tongue in cheek FDA finally approves cannabis medicine with photo of Epidiolex

Image Credit: via cannabis.net

We speculated about this back in July when the FDA approved the release of Epiodiolex. Because, surely, no sane government (oxymoron alert) agency could allow the approval of cannabis-derived medicine but disallow cannabis itself. Certainly the DEA must be frantically preparing a total reversal on its May, 2018 CBD scheduling fubar. Surely.

No, actually. The DEA appears were actually paving the way for Big Pharma by placing CBD on the Schedule I list in the first place, just prior to the FDA approving the pharma CBD product three months later. Have you thrown your computer out the window yet?

DEA

Image Credit: Belish

So, guess how many cannabis medicines this new de-scheduling bonanza covers? One. Just Epidiolex. And I must add a caveat on the use of the word “medicine” as there are so many dangerous side effects coupled with questionable efficacy, that it may not earn that qualification.

The Side Effects and Downsides of Epiodiolex compared to CBD

Epiodiolex is GW Pharmaceutical’s attempt at an anti-seizure medication that matches the efficacy of full-spectrum cannabis, such as Charlotte’s Web. It doesn’t, as we covered: here. It has been actually shown, in some patients, to increase seizure frequency and status epilepticus. What? Will the real cannabis please stand up because we know ain’t nobody got time for that. Take a read for yourself, this comes straight from the FDA website.

“The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.”

“Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks. Epidiolex also caused liver injury, generally mild, but raising the possibility of rare, but more severe injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice and/or dark urine.”

Meanwhile, CBD has a good safety profile and its side effects are minimal and non-threatening. According to the Mayo Clinic the compound “is often well-tolerated” but “can cause side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness and fatigue. CBD can also interact with other medications you’re taking, such as blood thinners.

Warnings and Precautions When Using Epidiolex

  • Hepatocellular Injury: EPIDIOLEX can cause transaminase elevations. Concomitant use of valproate and higher doses of EPIDIOLEX increase the risk of transaminase elevations. See full prescribing information for serum transaminase and bilirubin monitoring recommendations
  • Somnolence and sedation: Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX. (5.2)
  • Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts. (5.3)
  • Hypersenstivity Reactions: Advise patients to seek immediate medical care. Discontinue and do not restart EPIDIOLEX if hypersensitivity occurs. (5.4)
  • Withdrawal of Antiepileptic Drugs: EPIDIOLEX should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus. (5.5)
Epilepsy

Image Credit: Kateryna Kon

The opening to get CBD medicine approved is now so narrow, few will be able to fund the marathon to FDA approval. And this may actually cause burden to patients by reducing competition in the market and allowing gut-gouging prices to be the norm. Estimates say that Epidiolex will cost the average patient $32,500 USD per year to stay maybe seizure-free, probably not, but watch out for that pesky suicidal ideation.

Incidentally, the cost is tens of thousands above even the tippy top shelf high-CBD medicine. Think about that.

Epidiolex will hit market in about six weeks.

Jennifer Grant

Jennifer is Editor in Chief for Rxleaf. She has been employed as a professional writer for over fifteen years. Jennifer graduated from the University of Guelph with an Honors Biological Science degree, majoring in the biomedical field.

No Comments

Post a Comment