- Medical marijuana (also called medical cannabis) is whole plant marijuana or chemicals in the plant used for medical purposes.
- Cannabinoids are substances in medical cannabis that act on cells in the body, including the brain. The two main cannabinoids used in medicine are tetrahydrocannabinol (THC) and cannabidiol (CBD).
- The FDA recently approved the use of Epidiolex (a plant-based formulation of CBD) to treat seizures for people 2 years of age and older with Dravet syndrome and Lennox-Gastaut syndrome (LGS).
- Medical cannabis, CBD, and THC all have possible side effects. The most common side effects of CBD included sleepiness, diarrhea, fatigue, and decreased appetite. CBD also interacts with some other seizure medicines.
- Careful monitoring of CBD is needed.
Source: Epilepsy Foundation
- Treating Seizures and Epilepsy
- About Epilepsy: The Basics
- Types of Seizures
- Types of Epilepsy Syndromes
- Triggers of Seizures
- Quality Care in Epilepsy
- Seizure First Aid and Safety
- Managing Your Epilepsy
- Seizure and Epilepsy News
- Early Death and SUDEP
- Find a Clinical Trial
- Refractory Epilepsy (Difficult to Treat Seizures)
- Challenges with Epilepsy
- Special Populations
- Learning Network
The Journal of Child Neurology hosted a special report podcast about cannabis on March 6, 2017. In the report, Dr. Alison Christy interviews Dr. Jackie Gofshteyn, a resident in pediatric neurology at Children’s Hospital of Philadelphia, about her article, “Cannabidiol as a Potential Treatment for Febrile Infection-Related Epilepsy Syndrome (FIRES) in the Acute and Chronic Phases.” Dr. Christy also speaks with epilepsy.com’s medical cannabis editor, Dr. Anup Patel of Nationwide Children’s Hospital, about his article, “Medical Marijuana in Pediatric Neurological Disorders.” Margo Roemeling, a third year medical student at Oregon Health and Sciences University, shares the learning topic on the history and use of marijuana in the treatment of pediatric neurologic conditions.RELATED ARTICLES & NEWS
- Effect of Cannabidiol on Drop Seizures in the Lennox–Gastaut Syndrome, September 2018
- Cannabis and Seizures: Questions to Consider, September 2018
- Epilepsy Foundation Statement on the FDA’s Approval of Epidiolex, June 2018
- Epilepsy Foundation Testifies Before FDA Advisory Committee in Support of Potential First-Ever Cannabidiol Drug to Treat Dravet Syndrome, April 2018
- A Parent’s Perspective: the LGS Epidiolex Study, January 2018
- Data on Purified CBD, Epidiolex, for Dravet Syndrome, May 2017
- Cannabis & Seizures: Questions to Consider, March 2017
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 syndromeand 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.
- Statement on DEA Rescheduling Epidiolex
- Q&A on the DEA Rescheduling of Epidiolex
- Advocacy FAQ: Medical Cannabis and CBD
- Advocacy FAQ: FDA-Approved Therapies from CBD
- State FDA pathway
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 studies exist to support the use of CBD in epilepsy?
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.