Title

LVHN Position Statement: Use of Medical Marijuana for Epilepsy / Intractable Seizures

Publication/Presentation Date

1-10-2019

Abstract

LEHIGH VALLEY HEALTH NETWORK

POSITION STATEMENT ON THE USE OF MEDICAL MARIJUANA

FOR EPILEPSY/INTRACTABLE SEIZURES

Introduction/Background

Epilepsy is a common neurologic disease which causes recurrent, unprovoked seizures or a heightened tendency toward recurrent unprovoked seizures. Epilepsy can also be part of a chronic, neurologic syndrome. Seizures are paroxysmal, episodic events resulting in sudden but transient changes in behavior, sensory, motor or visual symptoms caused by abnormally excessive cortical brain activity. There are multiple causes of epilepsy with multiple different brain chemical changes. These are too varied and complex to summarize here.

The American Academy of Neurology (AAN) performed a systematic review of the efficacy and safety of medical marijuana in neurologic disorders published in 2014 (1) . It pointed out that there are many pharmacologically active compounds in marijuana. A compound called Cannabidiol is responsible for most of the therapeutic effects. There are cannabinoid receptors in the brain.

The report of the Guideline development subcommittee of the AAN on medical marijuana on various neurologic disorders including epilepsy was published in 2014(1). It reviewed only placebo controlled studies and did not include case reports or surveys. The studies included in this guideline did not demonstrate significant benefits and did not show adverse effects over 3-18 weeks of treatment.

The American Epilepsy Society (AES) Position on Cannabis as a Possible Treatment for Epileptic Seizures as of December 20, 2018 states that over the last several years, there has been great interest in the medical and scientific communities to explore the potential of cannabidiol (CBD), a non-psychoactive phytocannabinoid, to treat difficult-to-control epilepsy. Until recently, only anecdotal reports existed to support CBD’s use in treating epilepsy. Recently, important research data have emerged in the form of scientifically rigorous, double-blind randomized clinical trials on the use of a pharmaceutical formulation of purified, highly concentrated CBD for refractory epilepsy. These trials demonstrated that purified CBD is moderately more effective than placebo in the treatment of seizures in both Lennox-Gastaut syndrome (LGS) and Dravet syndrome. However, these trials showed that CBD has more side effects than placebo, and revealed previously un-recognized drug-drug interactions. (2).

The results of these scientifically rigorous randomized clinical trials led to the FDA approval of a pharmaceutical formulation of purified CBD to treat persons with epilepsy (Epidiolex®) .This drug is a Schedule V product available by prescription only, and provided by specialty pharmacies. Persons with epilepsy must use caution because there is a vast array of other cannabis products, and availability is dependent on individual state laws. Of importance, the purified, pharmaceutical formulation of CBD described above cannot be obtained from a marijuana dispensary. When patients purchase cannabis-based products from a dispensary, it is extremely important to understand that the product they select may not contain just CBD, but also other phytocannabinoids such as THC (which is psychoactive), pesticides, and other dangerous impurities, of which the concentrations are unknown. Independent laboratory testing of samples of cannabis products have shown that the labels on products in the dispensaries claiming to have a certain percentage of CBD or THC are often incorrect. (2).

While there are anecdotal reports of positive effects of cannabis and/or other CBD products on seizures, it is imperative that we remember that anecdotal reports alone are not sufficient to support treatment decisions. Robust scientific evidence for the use of cannabis itself in the treatment of epilepsy is limited. The lack of information does not mean that cannabis is ineffective for epilepsy, but it just means that providers do not have the required data needed to adequately inform rational clinical decisions for our patients with epilepsy. (2).

Conclusions about using medical marijuana to decrease the frequency of seizures in epileptics in this position statement is based on the above data with review of the literature. This includes literature from both the AAN and the AES Position Statements and it also includes the results of a questionnaire given to Lehigh Valley Health Network (LVHN ) neurologists in the past who have additional subspecialty training in epilepsy in which both neurologists who treat adults and children were sent the questionnaire.

Based on these, a review for adult neurology epilepsy in 2014 stated the following conclusion: “For patients with epilepsy, data are insufficient to support or refute the efficacy of cannanbinoids for reducing seizure frequency”. (3)

The adult and pediatric LVHN neurologists questioned for this position statement have no intention of offering this treatment to their epilepsy patients at the present time remain the same overall with the only exception now , since we do have an FDA approved medicine as of June 25, 2018 , that the neurologist can now choose to prescribe for the FDA-approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome. (4)

LVHN Recommendation:

Direct Therapy of Epilepsy: At the current time LVHN does not support the use of medical marijuana for the treatment of epilepsy. The only exception will be for an FDA approved medication currently only Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older

We still encourage participation in clinical trials exploring the effectiveness, adverse effects, safety profile, and appropriate dosing, frequency and administration of medical marijuana in diseases such as epilepsy for both adult and pediatric patients.

LVHN providers at this time will not be authorized to certify their own patients for use of medical marijuana to treat this condition outside of a research study except for an FDA approved medicine. Further study and Guidelines will be developed to manage those patients prescribed medical marijuana elsewhere who present for care at a LVHN acute care facility.

References

1.Patel A FD, Brust J, Song S, Miller T, Narayanaswami P. Position Statement: Use of Medical Marijuana for Neurologic Disorders [online]. Available at: https://www.aan.com/uploadedfiles/Website_Library_ Assets/Documents/6.Public_Policy/1.Stay_Informed/2.Position_Statements/3.PDFs_of_all_Position_Statements/Final%20Medical%20Marijuana%20Position%20Statement.pdf. Accessed 2014.

2.The American Epilepsy Society (AES) https://www.aesnet.org/clinical_resources/medical%20marjuana

3. The American Academy of Neurology (AAN) https://www.aan.com/Guidelines/home/GetGuideline Content/651

4 .The U.S. Food and Drug Administration (FDA ) https://www.fda.gov/bewsevents/newsroom/ pressannouncements/ucm611046.htm

Version 1.10.2019 (Submitted by Dr. Sameh Morkous)

Disciplines

Medicine and Health Sciences | Pediatrics

Department(s)

Department of Pediatrics, Department of Pediatrics Faculty

Document Type

Response or Comment

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