Epidiolex Is Not Pure - Says Report, Beware !
Quote from Article Below: It is worth mentioning that Epidiolex is not pure CBD – nor is it the same concentration of CBD found in all of those hemp products that have found their way to the U.S. market.
Article: Marijuana or Hemp: FDA Says Beware Of CBD For These Reasons
The U.S. Food and Drug Administration (FDA) wants the American public to know that cannabidiol (CBD), the non-intoxicating component of the cannabis sativa plant, might not be as safe and effective in the grand scheme of their overall health and wellness as they are being told.
The agency recently published a consumer update on its website (FDA.gov) that addresses some of the many claims surrounding this prevalent cannabinoid and attempts to dispel the notion that it is some kind of risk-free miracle drug.
Although the FDA is presently gathering data from health professionals, cannabis industry representatives and patients in hopes of learning more about how CBD might be used to combat (or even cure) the various blights to civil society, as for now, "there are many unanswered questions about the science, safety, and quality of products containing CBD," the agency wrote.
Therefore, the FDA wants to clarify a couple of critical points surrounding CBD before more of the public jumps on the bandwagon.
Research Shows CBD Can Cause Liver Damage
The FDA admits that it does not yet have a real understanding of the potential health risks (or benefits) associated with CBD. But liver damage is one of the side effects that it has uncovered in its limited study.
During the clinical trials for the CBD-based epilepsy drug Epidiolex, which was approved for the U.S. market just last year, researchers found the medication caused liver toxicity in some patients.
"The FDA identified certain safety risks, including the potential for liver injury," the agency wrote.
It is worth mentioning that Epidiolex is not pure CBD – nor is it the same concentration of CBD found in all of those hemp products that have found their way to the U.S. market. The solution, which is available only by prescription, also contains "dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose," according to drug maker GW Pharmaceuticals. However, the CBD used in this medicine (purified 98% oil-based CBD extract) is derived from the cannabis plant and not synthetically produced in a lab somewhere, as many have argued. This means Epidiolex is nearly 100 percent cannabis-derived CBD. It’s hard to argue that less prevalent ingredients are the culprit.
Even outside research on the subject of CBD and liver toxicity (using Epidiolex) finds that damage is possible in high doses.
Last month, Forbes featured a study from the University of Arkansas for Medical Sciences that found high doses of CBD brought about liver damage in mice within 24 hours. Many of the animals died or were close to death within three or four days. Critics have argued that the dosage used in this study was extreme, but the highest dosage used (615mg/kg for 10 days) was the "the allometrically scaled mouse equivalent… of the maximum recommended human maintenance dose." So while the dosage of Epidiolex leading to liver damage in mice was, in fact, high, there are epileptic children in the U.S. right now being administered a comparable amount. This is the reason that, according to the prescribing information for Epidiolex, doctors must monitor the liver enzymes of these patients. In clinical trials, 5 to 20% experienced liver issues. As a result, some patients were permanently removed from the study to prevent the damage from escalating.
Even doctors in Colorado, where marijuana is legal for any purpose, monitor the liver enzymes of patients who decide to treat themselves with CBD or marijuana, according to a report from STAT News.
So the threat is real.
The most common side effects associated with CBD-based Epidiolex include: “sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.”
More serious side effects include “thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks,” the FDA wrote in a news release.
But what about my hemp-derived CBD products?
While it is not likely that all of those CBD gummies and oils that Americans are consuming these days will present any harm to their livers (most of these products are weaker concoctions than Epidiolex), the reality is we just don't know for sure if injury is possible in high enough doses. After all, many other herbal supplements on the market today can cause liver damage, as well. These products, like CBD, are not regulated by the FDA, and have been shown to produce this adverse effect in high doses.
CBD Probably Doesn't Cure Cancer or Any Other Disease
The FDA also wants Americans to understand that none of the CBD products being sold in grocery stores, truck stops, health food stores, or medical marijuana dispensaries have been given its stamp of approval. Not even the hemp-derived CBD sold down at your local CVS or Walgreens is revered as medicine.
So far, Epidiolex is the only CBD-based drug in the United States to be awarded this privilege. It took its manufacturers (GW Pharmaceuticals) several years to prove to the FDA that its drug had the power to safely and effectively control the frequency of seizures.
Throughout this process, however, the FDA determined that Epidiolex was really only useful as a treatment for children suffering from two rare forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.
The drug has not been cleared for any other health condition.
But even in the case of epilepsy, Epidiolex is not a sure thing. This medication was only found effective in 32 percent of patients.
Not exactly a miracle cure.
But that hasn't stopped the cannabis industry from trying to convince the public that CBD can remedy their pain, help with anxiety, pull them out of depression, give them healthy hearts and even protect them from cancer. The FDA worries that all of the unsubstantiated allegations floating around about how CBD can help relieve or even cure all sorts of medical conditions will give consumers a false sense of hope.
"Misleading and false claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment, and supportive care," the FDA wrote.
"The agency has warned companies selling CBD products they claim are intended to prevent, diagnose, treat, or cure serious diseases such as cancer, Alzheimer's disease, psychiatric disorders and diabetes."
We should point out that the FDA, while designed to protect public safety when it comes to food and drugs, is not exactly infallible.
The agency has approved several prescription drugs over the years, only to end up recalling them years (sometimes decades) later. Some opioid painkillers, ADHD drugs, cholesterol medications, and antihistamines have eventually been pulled from the shelves due to cases where patients suffered severe or life-threatening adverse reactions as a result of these medications.
A study published in 2017 found that nearly a third of all FDA-approved drugs from 2001 to 2010 were later flagged for a safety threat.
"The key message with all new drugs and technology is that there is an ongoing learning process that will continue through the lifetime of the drug," lead author Dr. Nicholas S. Downing told CNN.
Drugs are only completely removed from the market "when its risks outweigh its benefits," according to the FDA. So, what is deemed safe for public consumption today could end up wreaking havoc on them in the future. Perhaps this is the reason that the latest Gallup poll shows that only 44 percent of the public believes the agency is doing an excellent job. A lot of Americans simply do not trust the FDA to provide them with the truth about medicine.
On the flipside, we know very little about CBD at this juncture. More research is needed before we can begin to truly weigh the pros and cons of this cannabinoid and gauge its medicinal function.
The best piece of advice for someone considering the use of CBD to help pull them from the trenches of a serious medical condition is to consult with their family physician, oncologist or other specialists to ensure they are not putting their well-being or life at risk.
Just don't buy into the CBD hype blindly.
Although, as far as we know, cannabis derivatives are safer than other medications, we still have a lot to learn about this cannabinoid before we can say, without a shadow of a doubt, that its safety and efficacy for conditions ranging from pain management to cancer treatment has been adequately evaluated.
Be careful out there, folks!