The People's Perspective on Medicine

What Will FDA Approval of Cannabidiol Mean for You?

For some children with hard-to-treat epilepsy, approval of cannabidiol will mean fewer seizures and a better quality of life.
Hand with pen drawing the chemical formula of CBD

The Food and Drug Administration recently approved the first drug made from Cannabis sativa. This plant is known more often as marijuana. FDA approval of cannabidiol under the brand name Epidiolex is for treating two nearly intractable types of epilepsy in children. One is called Dravet syndrome, while the other is termed Lennox Gastaut syndrome. These specific syndromes are rare. However, GW Pharmaceuticals, the manufacturer, may be hoping that eventually its purified cannabidiol extract will prove useful against other maladies.

Approval of Cannabidiol as Medicine:

The company conducted three randomized placebo-controlled trials. In them, children with one of these hard-to-treat syndromes took either Epidiolex or placebo. All the youngsters in the studies also took another anticonvulsant drug. The drug does have side effects. Youngsters taking Epidiolex often felt drowsy, acted lethargic, had little appetite and experienced digestive problems such as diarrhea. Some had elevated liver enzymes, rash, infections and trouble sleeping. Still, such side effects pale in comparison to the benefit of controlling hard-to-manage seizures.

While medical marijuana is legal in a number of states, Epidiolex will at some point be legal everywhere in the country. Despite FDA approval, Epidiolex is still classified as a drug of abuse without medical merit. Before doctors can prescribe it as an ordinary anticonvulsant rather than a research compound, the FDA will need to change its classification. Because of the link to cannabis, this may prove politically sensitive.

Epidiolex is a far cry from marijuana, however. It may be derived from a natural product, but it has pharmaceutical-grade quality control behind it. Most natural product purveyors don’t have that capacity, so their cannabidiol (CBD) oil is likely to vary somewhat from one batch to the next.

The principal fear with marijuana is that people might abuse it in their enthusiasm for getting high. Epidiolex is not susceptible to that type of abuse, since it contains no compounds such as tetrahydrocannabinol (THC) that can produce a high. That is true in theory for other forms of CBD as well. Nonetheless, it is not clear that all are purified adequately to remove any traces of THC.

Uncertainties about Cannabidiol:

One big question about the approval of cannabidiol in the form of Epidiolex is whether and to what extent insurance will cover the cost. Much of the research was done at the drug company’s expense, but now that FDA has approved it, people who take it will have to find a way to cover the cost. While doctors can prescribe it off label for other types of epilepsy, insurance companies are under no obligation to cover off-label uses of any medicine.

Here is a link to a story we wrote before the approval of cannabidiol. It will be interesting to see how this story unfolds in the coming months.

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies. .
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Very interesting comments about the side effects.
Here is the list from drugs.com
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Active ingredient: cannabidiol

Inactive ingredients: dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose Epidiolex does not contain gluten (wheat, barley or rye).
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Sucralose – that explains the diarrhea.

Right now there’s an amazing amount of innovation with CBD-based compounds in the non-profit research sector and in private production, leading to new uses and falling prices.

I dread FDA approval of a CBD-based compound because it will open the door for the usual heavy regulation and high prescription costs that we get from the FDA-Big Pharma machine. The only winners will be the FDA bureaucrats and Big Pharma executives (who regularly trade places).

First off, I think the Approval of CBD is a tremendous thing! I have witnessed first hand the incredible pain relieving benefits CBD has with my Statin muscle and nerve pain. And unlike many pharmaceutical drugs, I have witnessed CBD’s ability to EFFECTIVELY treat seizures.

The only way to screw it up is to let a Pharmaceutical Company Patent it in the form of a DRUG, which allows the company to CONTROL prices, and we have witnessed that with Martin Shkrelli and many others who’s sole purpose on this planet is $$$..

I would not want to take Epidiolex. It will have side effects (Cannabis does not) Remember this: The FDA can not patent a plant Like Marijuana, they always have to put a drug with it, and it will have side effects, I learned that from working for a vitamin company for 16 Years.

(So take the real thing.)

Hurrah that the healing properties of cannabis are finally being researched! That said, I would be hesitant to give this Epidiolex to a child suffering from these ailments for this reason: CBDs just do not cause the sides effects listed, at all! What on Earth else have they added to this medication?? Because of this concern, I would at this point only recommend for these kids the CBD oil from the company in Colorado named after a famous Children’s book

I recently read an article about using a drop of organic caster oil in the eyes for dry eyes and floaters. Do you know any thing about this. Thanks

It works. Grannies’ tale but it works well.

We don’t recommend this. Never put anything in your eyes unless your eye doctor has suggested it.

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