Initially, we were captivated by the front-page article “‘Seize’ the Opportunity: Update your approach to pediatric seizures,” authored by Drs. Garber and Glauser, in the November 2018 ACEP Now. Although we value the authors’ summary of this complex topic, we feel the section titled “Select Antiepileptic Drugs” on page 13 lacked sufficient detail on indications and contraindications for cannabinoids. The indications listed for cannabinoid AEDs included only “case reports for treatment of severe drug-resistant epilepsy,” but three other AEDs (felbamate, adrenocorticotropic hormone, and rufinamide) warranted an indication for Lennox-Gastaut syndrome. We feel this summary may understate the utility of cannabinoid AEDs and clinical efficacy demonstrated for this medical therapeutic category in managing intractable pediatric seizures. Our goal is to build on the work authored by Dr. Garber and Dr. Glauser to expand on the use of cannabinoids for this indication.
Explore This IssueACEP Now: Vol 38 – No 04 – April 2019
The proof for cannabinoids in managing pediatric seizures extends well beyond anecdotal case reports or the international case series referenced in the article. For example, a recent study presented long-term data on patients with treatment-resistant epilepsy who added cannabidiol (CBD), a chemical constituent of the cannabis plant, as an adjunct to their current anticonvulsant therapies.1 “Add-on CBD reduced median monthly convulsive seizures by 51% and total seizures by 48% at 12 weeks; reductions were similar through 96 weeks,” the authors write. The take home message is that in patients who experience seizure reduction, this benefit appears to be stable over the long term.
In June 2018, the FDA announced it approved Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients age two years and older. Epidiolex contains CBD extracted from the cannabis plant and is the first FDA-approved drug to contain a purified extract from the plant. Subsequently, the DEA announced in September of 2018 that Epidiolex was being placed in schedule V of the Controlled Substance Act (CSA), the least restrictive schedule. In a related press release, FDA Commissioner Scott Gottlieb, MD, stated, “Adequate and well-controlled clinical studies supported Epidiolex’s approval, so prescribers can have confidence in the drug’s uniform strength and consistent delivery that supports appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high-quality products.”
CBD oil may soon be more accessible for patients as derived from hemp. One big reason for this is the passage of the 2018 Farm Bill in early December. Within the Farm Bill is a provision known as the 2018 Hemp Farming Act, which legalizes the cultivation of industrial hemp in the United States for the first time in nearly a century. (Hemp got thrown into the mix with the Marijuana Tax Act of 1937, and until recently, it has been against federal law to grow it, though many states allow it.)
Just imagine walking into your local Walmart and seeing an entire section of hemp-derived CBD products. Everything from oils to nutritional bars to hemp-based drinks will likely be available soon. The health benefits are increasingly being documented in observational studies, and legalization will take the hemp-CBD market to a whole new level.
Given the FDA, the DEA, and neurologists can at least articulate support for Epidiolex based on rigorous clinical research as a cannabidiol that is proven clinically safe and effective in treating these complex and serious epilepsy syndromes in pediatric patients, we wanted to take this opportunity to add some balance to the AED discussion and highlight these landmark advances in this area of clinical interest for ACEP members.
Kevin Takakuwa, MD
San Francisco, California
Rocky M. Schears, MD, MPH, MBA, FACEP