The use of cannabis to treat epilepsy and other neurological conditions has been studied for a number of years. It has been hotly debated too.
On June 25, 2018, the U.S. Food & Drug Administration (FDA) approved EPIDIOLEX ® (cannabidiol, CBD) oral solution for the treatment of seizures associated with two epilepsy syndromes – Lennox-Gastaut syndrome and Dravet syndrome – in people two years of age or older. Epidiolex represents a new medication option for children with these types of epilepsy. It is also the first ever FDA approved medication to treat seizures in Dravet syndrome.
What does FDA approval of Epidiolex (CBD oral solution) mean?
The FDA approval and Drug Enforcement Administration (DEA) scheduling of Epidiolex brings to market the first plant-based drug derived from the cannabis plant in the U.S.
What is medical cannabis?
Cannabis is known by many names – the most common is marijuana. Cannabis is the Latin name used most often by botanists and pharmaceutical companies. The word marijuana usually refers to the leaves and female flowers of the cannabis plant. Medical cannabis is whole plant marijuana or chemicals in the plant used for medical purposes.
Cannabinoids are substances in cannabis that act on cells in the body (called cannabinoid receptors) to cause some effect. Two major ingredients include
- Tetrahydrocannabinol, or THC, which causes the psychoactive effects of “getting high”
- Cannabidiol, or CBD, which does not cause psychoactive effects but has shown some positive effects on certain body systems. This is the part that has been effective in reducing seizures in some people with epilepsy.
Does cannabis help seizures?
Early evidence from laboratory studies, anecdotal reports, and small clinical studies over a number of years suggest that cannabidiol (CBD) could potentially help control seizures. Research on CBD has been hard to do and taken time due to federal regulations and limited access to cannabidiol. There are also many financial and time constraints. In recent years, a number of studies have shown the benefit of specific plant-based CBD product in treating specific groups of people with epilepsy who have not responded to traditional therapies.
What do I need to know about hemp?
Hemp is a variety of Cannabis Sativa L. plant historically grown for fibrous materials found in its stalks and seeds. It has been used to make items such as clothing fiber, upholstery, and other household items.
Hemp traditionally contains lower concentrations of THC and higher levels of CBD. Cannabinoids extracted from hemp plants, including CBD, have until recently been classified as marijuana and considered Schedule I substances. Per the DEA, Schedule I substances currently have no accepted medical use and have a high potential for abuse. A federal law* enacted in December 2018, however, reclassifies hemp and hemp-derived CBD as an agricultural commodity and exempts it from the list of Schedule I Drugs.
Despite this change in the classification of hemp and hemp-derived CBD, the only CBD product that has been rigorously studied and approved to be used as a medical therapy for epilepsy is the drug Epidiolex. While more CBD products may come to market in the coming months, it is important to understand that not every CBD product is the same quality or uniform from batch to batch. Any drug or supplement that is being considered for use as a medical treatment should first be discussed with your doctor. The potential for benefit as well as the interaction with other seizure medications and possible side effects require careful review with your doctor.
*The Agriculture and Nutrition Act of 2018 (H.R. 2) legalizes hemp and hemp-derived CBD. The bill changes the definition of hemp to encompass any plant or product derived from the plant that contain less than 0.3% THC by dry weight and classifies them as exempt from the controlled substance restrictions applied to marijuana. The law further amends the Controlled Substances Act to exempt hemp from Schedule I drugs.
What do I need to know about hemp?
Epidiolex (Cannabidiol, CBD)
Studies in the U.S. of Epidiolex (a plant-based CBD formulation) have been ongoing for a number of years. Data from these studies has helped provide evidence that led to the FDA approval of this product on June 25, 2018.
Epidiolex is a purified (> 98% oil-based) CBD extract from the cannabis plant. It is produced by Greenwich Biosciences (the U.S. based company of GW Pharmaceuticals) to give known and consistent amounts in each dose.
Researchers studied this medicine in controlled clinical trials. These studies used a control group with some people taking a placebo while others were given CBD at different doses. Researchers did not know who was getting the placebo and who was getting CBD. These tpyes of studies are called “gold standard” studies.
A summary of the Epidiolex clinical trials is found below:
- In controlled and uncontrolled trials in people with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, 689 people were treated with Epidiolex (CBD), including 533 people treated for more than 6 months and 391 people treated for more than 1 year.
- In an expanded access program and other compassionate use programs, 161 people with Dravet syndrome and LGS were treated with Epidiolex, including 109 people treated for more than 6 months.
- All study participants were taking other seizure medications.
- In controlled trials, the rate of stopping the medicine due to any side effect was small and happened most in people taking the higher dose of Epidiolex.
- The most frequent cause of stopping treatment with Epidiolex was a change in liver function.
- Sleepiness, sedation, and lethargy led to stopping Epidiolex in 3% of people taking the higher dose.
- The most common side effects were sleepiness, decreased appetite, diarrhea, change in liver function, fatigue, malaise, asthenia (weakness or lack of energy), rash, insomnia, sleep disorder, poor quality sleep, and infections.
Results from Gold Standard Studies of Epidiolex (CBD)
NEJM May 2018
Summarized below are the results from a study published in the New England Journal of Medicine in May 2018.
CBD for Seizures- Use, Effectiveness, Side Effects, and More
If you have seizures or are the parent of a child who has seizures, then you are probably constantly on the lookout for ways to control seizures with as few side effects as possible. CBD oil is one of the latest things to be touted as a miracle cure for seizures. While its effects are not the miracle cure some people suggest, it is a promising treatment that might be right for you.
What is CBD?
CBD is short for cannabidiol, which is a chemical found in marijuana. It is not the same as tetrahydrocannabinol (THC), the chemical in cannabis that is responsible for the “high” feeling people get from marijuana.
What does CBD do?
Well, people make many claims about what CBD can do. Not all of them have been tested and verified. However, there is support for claims that CBD may help reduce pain and anxiety.
Does CBD help seizures?
The short answer is yes. CBD can help prevent some types of seizures in some people and animals. Clinical trials have demonstrated a significant reduction in seizures for people taking CBD to treat Lennox-Gastaut, Dravet syndrome, or tuberous sclerosis complex. Research in other areas is still in early stages, but there are indications that CBD may help prevent other types of seizure or increase the efficacy of other antiepileptic medications. Early clinical trials suggest that CBD may dramatically reduce seizures in people with CDKL5 deficiency disorder, Aicardi syndrome, Doose syndrome, and Dup15q syndrome. In addition, CBD appeared to retain its efficacy over the length of the clinical trial.
How does CBD help prevent seizures?
That is a wonderful question, but, unfortunately, the research simply is not sufficient to give a definitive answer. What we do know is that bodies contain natural neurotransmitters and receptors known as the endocannabinoid system. CBD is believed to interact with that system, which is believed to influence a range of bodily functions and systems including immune response, appetite, pain, and sleep.
Is CBD approved by the FDA to treat seizures?
Yes, but not all CBD oils and not all types of seizures. Currently, Epidolex, a prescription form of CBD, is approved to treat seizures caused by Lennox-Gastaut, Dravet syndrome, and tuberous sclerosis complex.
Does CBD interact with other seizure medications?
Yes. We know that CBD interacts with brivaracetam, clobazam, eslicarbazepine, stiripentol, rufinamide, topirimate, valproic acid, and zonisamide. It also possible that it interacts with other antiepileptics, and as research continues, we should have a better idea of other possible interactions.
How do I use CBD or CBD oil to treat seizures?
If you have a seizure disorder, you should be seeing a neurologist for treatment. It is very important to discuss whether you should use CBD oil with your neurologist. While it is generally safe to use, there is always a risk of potential drug interactions. In addition, some people actually experience an increase in seizures when they use CBD. Therefore, just like with any antiepileptic drugs, you want to have a professional monitoring your use of CBD.
What is an average clinical use of CBD to treat seizures?
The starting dose for CBD is 2.5 mg/kg of Epidolex, two times a day. A normal maintenance dosage is 5mg/kg twice daily, and the maximum dosage is 10mg/kg twice daily. As with other antiseizure medications, it should be introduced or stopped gradually, as sudden changes can increase seizure activity.
What are the potential side effects of CBD when used to treat seizures?
Whether used alone or with other seizure medications, there are some potential side effects of using CBD to treat seizures. It can lead to an increase in suicidal thoughts or behaviors, sleepiness, drowsiness, diarrhea, and loss of appetite. While most of these side effects are inconvenient, interactions can also cause liver damage.
Can CBD increase my seizures?
This is a tricky question to answer. Anecdotally, it seems clear that some percentage of people will have an increase in the number of seizures in response to using CBD. However, why is not so clear. Research seems to suggest that people who use commercial CBD products are likely to see an increase in seizures, while people using prescription CBD are likely to see a reduction in seizures. The speculation is that commercial products are not pure CBD, but are tainted with THC, which is known to be a potential seizure trigger.
Can I use over-the-counter CBD to treat epilepsy?
The problem with OTC CBD is that it is not regulated by the FDA. This makes it impossible to know what dose you would be getting, if the product is contaminated with impurities, or if it even is CBD. If you want to explore using CBD to treat seizures, talk with your doctor about adding Epidolex, an FDA regulated product that eliminates the specific risks posed by an OTC product, to your treatment plan.