CBD Offers New Hope for Seizure Relief
Cannabidiol (CBD), a cannabinoid produced by the cannabis plant, is receiving growing attention because it has potential medical benefits for a wide array of conditions, including epilepsy. Epidiolex is the first prescription CBD made available. It was approved by the United States Food and Drug Administration (FDA) on June 2018. Epidiolex was approved for treating seizures in two forms of epilepsy that are especially difficult to treat. These are Dravet syndrome and Lennox-Gastaut syndrome (LGS). Both adults and children over two years old who suffer from one of these rare forms of epilepsy can be prescribed Epidiolex.
LGS and Dravet syndrome are two of the most severe forms of epilepsy. They are treatment-resistant which means that most common epilepsy medications do not work for these conditions. CBD is being studied for effectiveness with other kinds of epilepsy, and the introduction of Epidiolex to the market has created much buzz around CBD for seizures.
In this article, we will go over some of the basics about CBD and seizures. If you have any questions about CBD for epilepsy, talk to your doctor. Never make any medical changes without consulting your physician.
What Are CBD and Medical Marijuana?
Medical marijuana (or medical cannabis) is cannabis grown for medical or therapeutic purposes. Cannabis produces an abundance of compounds known as cannabinoids. Research shows that the cannabinoids produced by marijuana plants have potential essential health benefits. Cannabinoids can be used for medical purposes because they act on the body’s cells (including the brain). Cannabinoids do this through interaction with the body’s endocannabinoid system. The most commonly known and cultivated cannabinoids are cannabidiol (CBD) and tetrahydrocannabinol (THC). The latter is known for producing a “high” experience that CBD does not cause.
Medical marijuana is specifically bred for certain cannabinoids, so strains can be bred to have extremely low THC content. This brings many of the benefits of cannabinoids to the body without THC’s “high” effects. The distinction between high and low THC strains is often termed marijuana and hemp. However, they are simply varieties of the same cannabis species.
Epidiolex is a CBD-based seizure medication for patients two years or older who have Lennox-Gastaut or Dravet syndrome. The FDA recently approved this medication. It is the first medical marijuana product to be approved by the FDA and the first drug for the treatment of seizures from Dravet syndrome. Research into the potential uses of CBD and other cannabinoids for people suffering from seizures is ongoing. Medical cannabis has been hotly debated, especially politically, in recent years. Many legal difficulties made the use of medical marijuana difficult or even impossible to study until very recently. However, research on medical cannabis oil with neurological conditions, including epilepsy, has been conducted longer.
Lab studies, patient testimonies, and small clinical studies in recent years show CBD may reduce seizures. While the evidence is still growing, it currently indicates many positive potential qualities. New studies continue to show evidence that CBD can help patients with epilepsy. Dr. Orrin Devinsky is a professor of neurosurgery, psychiatry, and neurology at NYU School of Medicine. He found that cannabidiol significantly reduced seizures for patients with severe epilepsy. LGS could potentially be effectively treated using CBD. LGS is a treatment-resistant type of epilepsy, so this gives hope to many patients.
What Causes Seizures, and How Can CBD Help?
Seizures are caused by erratic electrical brain activity that spreads. They can cause altered states of consciousness and uncontrollable movements. Most antiepileptic drugs slow down the electrical brain activity to prevent seizures. Dravet syndrome and LGS are often treated using medications that are less commonly prescribed for other epilepsies. Both Dravet syndrome and LGS often need additional antiseizure medications to keep seizures under control.
However, both Dravet syndrome and LGS can be specifically treated using CBD. While it is not yet clear how the process works, CBD can reduce certain kinds of seizures. CBD works through the endocannabinoid system located throughout the body. This lets CBD have widespread effects on nerve cells in the brain that could be having impacts on seizures. In order to pinpoint the process further, researchers are currently studying CBD in more depth.
As a developmental disorder, LGS starts during early childhood. LGS causes multiple kinds of seizures, along with physical and cognitive development problems. LGS causes seizures that are more difficult to manage than other types. LGS seizures require different medication regimens than most epilepsy patients use.
Dravet syndrome, like LGS, is a developmental disorder that starts during early childhood. Dravet syndrome causes many seizure types, including seizures triggered by high body temperatures. People suffering from Dravet syndrome commonly have learning difficulties and behavioral difficulties.
Unfortunately, people with Dravet syndrome or LGS can still have regular seizures even while being treated. One of the most important potential uses of CBD is its potential to reduce the severity and seizure frequency for these patients. Studies are still being conducted on CBD’s effectiveness. Research already suggests that CBD could reduce symptoms if used with other anti-seizure medications.
In 2019, a review of studies done on Epidiolex indicated that the frequency of sustained seizures was reduced anywhere from 30 to 63 percent. The review also showed that patients treated with Epidiolex had seizures that were around half as severe as before. Seizures were accompanied by a less severe postictal state (post-seizure period).
Other studies that use CBD for controlling seizures focus on refractory seizures. Refractory seizures are not as easy to control with typical antiseizure medications. It is not yet known whether CBD will benefit these types of seizures or if people with different seizure types will respond well to it. Until benefits for other seizure types are established, CBD will not be approved as a treatment option for them by the FDA.
Currently, CBD as a treatment of epilepsy is still controversial since it is derived from medical marijuana. Cannabis has been known primarily as a recreational drug. This cultural stigma has slowed clinical research over previous decades. Thankfully, this is changing as cultural attitudes toward cannabis become more favorable. The American legal system continues to evolve on cannabis. Currently, CBD is only clinically established to be effective for a select number of medical conditions. Nevertheless, emerging evidence shows hopeful signs for CBD’s wide applicability in medicine. Research shows a potential quality-of-life improvement for people with many different conditions.
What Is the Legal Status of Medical Marijuana Products Like CBD?
The 2018 Farm Bill exempted hemp and hemp-derived products (like CBD) from the Controlled Substances Act. Before this, hemp products were classified as Schedule I cannabis. That meant they had no recognized medical use and a high potential for abuse. Both characteristics have been shown to be false. Pressure has grown from patients, doctors, and patient advocates on the federal government to legalize hemp. There are now no federal restrictions on CBD. Hemp can be legally cultivated, products can be legally manufactured, and both can be bought and sold throughout the United States. This does not mean that CBD is appropriate for everyone. Still, CBD has finally been recognized as having important medicinal value for many patients.
More than half of the states have laws that allow cannabis to be recommended to patients for specified medical conditions. These patients are then able to enter medical dispensaries to buy cannabis products. State medical cannabis programs are unaffected by the Farm Bill. Regulations involving medical cards, registrations, renewals, and recommendations from physicians are still required.
The FDA approved Epidiolex in June 2018. Medical providers can now prescribe Epidiolex for patients suffering from Dravet syndrome or LGS. This places Epidiolex among the numerous approved prescription seizure medications available. The DEA rescheduled Epidiolex to Schedule V in late September. The federal government then made provisions so Epidiolex can be brought to market. Unlike many state programs, health care providers need no special licenses to prescribe Epidiolex. So far, the FDA has approved no other medical formulations of cannabis for seizures or any other conditions.
Before Taking CBD for the First Time
Remember that less is often more with CBD, according to clinical trials. This is especially true when trying to treat epilepsy with cannabis products, like CBD or other cannabinoids. In one recent study on Epidiolex, patients actually seemed to perform better with 10 milligrams of the medication than with 20 milligrams. They also experienced fewer adverse events. Epidiolex is 99 percent pure CBD. Some doctors believe CBD is better with side effects compared to other available seizure medications. This may be especially true of seizures that are especially difficult to control, such as those with Dravet syndrome and LGS.
Epidiolex is made from a highly refined, pharmaceutical-grade CBD. This distinguishes it from the CBD in states with legal medical marijuana programs or even simply CBD products on store shelves. It is not known how well these products could aid people with epilepsy since the FDA does not regulate them. It is also unclear if CBD helps people who have more common forms of epilepsy. Caution is advised for anyone attempting to treat their epilepsy with CBD. Patients should consult their doctors before making any dietary, supplemental, or medicinal changes.
How to Take CBD for Seizures
Before using CBD or any cannabis product, consumers should consult with their physicians. This helps doctors alert patients to any potential side effects as well as monitor their symptoms more effectively. Obviously, to use Epidiolex, patients would need a prescription from their doctors. However, many CBD products exist as over-the-counter supplements, meaning anyone can consume them so long as it is legal in their state.
Epidiolex is offered to patients in liquid form as an oral solution. The recommended dose of the medication is based on patient weight. Ten milligrams for every kilogram each day is the most effective dose and is commonly split into two daily doses. Patients begin by taking a smaller dose of 2.5 milligrams per kilogram. After the first week, patients increase their dosage to the target amount. In more extreme cases, Epidiolex can be increased up to 20 milligrams per kilogram daily, but this comes with increased risks of adverse events. Like other anti-seizure medications, Epidiolex should be taken at the same scheduled time. Patients should never skip or combine doses.
Patients with Dravet syndrome or LGS can sometimes have difficulty ingesting oral medications. This is because of difficulty swallowing, cognitive issues, or behavioral challenges. It can often be difficult to get children to take medications. This leads many parents and doctors to develop personalized strategies to ease the process.
What Are the Side Effects of CBD?
When smoked, cannabis potentially has some of the same risks to lungs and heart health as other types of smoking. Although cannabis is a plant, it is broken down by the body’s liver like many other medications. Medication interactions can occur even with medications made from plants or plant oil. Certain side effects may be due to the form of CBD taken since oils could potentially cause an upset stomach or diarrhea. This is suggested by the fact that even placebo participants often reported these symptoms.
Certain medication interactions can occur that people with epilepsy should be aware of before using CBD. Patients with increased liver enzymes three times the normal rate or more were also taking VPA (valproic acid). VPA is a commonly prescribed seizure treatment. VPA levels were not raised when taken with CBD. It is believed that a byproduct or component of VPA may interact with CBD as it breaks down, putting some patients at increased risk of liver problems. Patients using Onfi (clobazam) experienced tiredness when using CBD, which may be caused by the drug interacting with CBD.
Most people do not seem to have any serious side effects from CBD or other cannabinoids. However, as with any medicine, supplement, or even dietary change, side effects are possible. Thankfully, in the minority of cases where they do occur, the side effects of CBD are generally mild and short-lasting. The potential side effects of prescription Epidiolex include:
- Sleeping Problems
- Decreased Appetite
- Rhinitis/Upper Respiratory Tract Infection
- Status Epilepticus (a long-lasting seizure that needs emergency medical attention)
Studies showed that these side effects were most common in the first two weeks of using Epidiolex. Generally, side effects lessened after this initial period. Many studies on Epidiolex involved other antiseizure drugs. Side effects could be from other medications or a mixture of those medications with Epidiolex.
Severe side effects that need immediate attention include jaundice, abdominal pain, and vomiting. Dark-colored urine could be a potential symptom of liver injury. Others are intense mood changes, such as depression, anxiety, or suicidal thoughts and feelings.
By itself, CBD shows no evidence of potential for abuse. CBD also does not produce the psychoactive “high” typically associated with cannabis. These qualities mean that consumers do not need to be concerned about anyone abusing CBD products or becoming addicted to it. There is great potential for misunderstanding of CBD and its effects. That is because it is a new compound for many people and comes from the same plant that THC derives from.
Research is still being done on whether and how CBD interacts with other antiseizure medications. This will be important since it will allow for more precise and effective use of CBD in treating epilepsy. Researchers believe CBD could raise the blood level of Banzel (rufinamide) and Topamax. It may decrease the blood level of Onfi (clobazam). This could have effects on seizure control and potentially cause side effects. CBD can potentially elevate liver enzymes when taken alongside other antiseizure medications. This can be a sign of liver injury, and medical attention should be sought immediately. Researchers find adding Epidiolex to a regimen can increase the chances of certain side effects. It might also decrease the number of side effects people experience.
Using CBD Without a Prescription
Epidiolex is only available by prescription. However, numerous companies produce over-the-counter CBD products. Some consumers have begun to use them as a supplemental seizure control. This trend will likely grow now that CBD has been made federally legal by the 2018 Farm Bill. More states are making CBD and hemp an important part of their economic planning.
The FDA does not regulate over-the-counter CBD or other cannabinoid products. So, they are largely untested unless companies pay for testing themselves voluntarily. The FDA warns people to be cautious since products can be mislabeled and overstate their potential benefits. Additionally, these products are not being tested by the government for quality and safety. People with epilepsy need to be especially cautious. Products may be mislabeled with dosages and could put consumers at risk of more seizures or other side effects.
One study from 2017 found that 26 percent of CBD products purchased online contained less CBD than companies claimed. These sorts of factors make it important to purchase only from transparent, trustworthy companies. Look for companies whose products are proven to be accurately labeled and safely processed.
What Do Studies on Epidiolex Show?
Studies on Epidiolex date back as far as from a few years ago helped the FDA to approve the medication on June 25, 2018. Epidiolex is produced by Greenwich Biosciences, the American arm of GW Pharmaceuticals. Epidiolex is designed to give consistent, easy-to-identify dosages. Epidiolex was studied in clinical trials using control groups. Some individuals were given placebos, while others received various doses of CBD. Researchers were not informed about which group received placebo group and which received CBD. These are typical examples of gold-standard studies. They are the best indication of whether treatments actually work.
In one study, 689 people with LGS or Dravet syndrome were treated with Epidiolex in both controlled and uncontrolled trials. Of those patients, 533 took Epidiolex for more than six months, while 391 were treated for over a year. In compassionate use and expanded access programs, 161 LGS or Dravet patients received Epidiolex. In addition, 109 of these patients were treated for more than six months. Each study participant was also taking one or more other medications to control their seizures.
Participants in controlled trials rarely had to stop using Epidiolex because of side effects. Usually, Epidiolex only caused side effects for those taking higher doses. Most often, the cause for stopping Epidiolex was symptoms of changes in liver function. Lethargy, sedation, and sleepiness were indications that led participants to stop taking CBD. This occurred in 3 percent of those taking the higher dosage. The side effects included decreased appetite, changes in liver function, diarrhea, and sleepiness. Weakness, fatigue, rashes, sleep problems, insomnia, and risk of infections were also reported.
Studies show that CBD with traditional seizure medications reduced drop seizures in LGS patients. Others showed that Epidiolex was useful in treating people with difficult-to-treat seizures caused by Dravet syndrome. CBD showed some indications of being associated with a higher frequency of adverse effects, often at higher doses. Several CBD clinical trials are ongoing or actively recruiting participants. Researchers are looking at using Epidiolex to treat Sturge-Weber Syndrome and Tuberous Sclerosis Complex.
Health Insurance and CBD
Because CBD is a new therapy for patients with epilepsy, some people may have difficulty with health insurance coverage. Some may even deal with the unavailability of medication. Because medical marijuana products are new, and some providers hesitate to pay for them, patients can feel lost about where to turn for help. Patients should consult their doctors for documentation to get approval for insurance coverage. Otherwise, they can get help finding a source that can help fill the prescription.
How to Travel with CBD Products
Traveling with CBD used to be more difficult than it is now. This is largely because some states have legalized CBD products while others had not. Hemp and hemp-derived products were still considered Schedule I cannabis at the federal level. There was no uniform approach to medical hemp products. Thanks to the 2018 Farm Bill, this is no longer the case. CBD products are legal on a federal level throughout the United States.
Nevertheless, because CBD is a cannabis product, there are some prudent steps to take when traveling with it. Keep all paperwork with CBD products to show that they are legal and in compliance with federal law. This is especially important if using hemp flower or other raw plant products. These could be mistaken for high-THC cannabis, which is still illegal under federal law.
Should You Use CBD Products?
Anyone considering CBD for therapeutic reasons should learn the potential risks and benefits. Patients considering medical marijuana should also understand that it may not be the right fit for them, even if it works for other people. For some people, CBD is simply ineffective, while for others, it can cause side effects.
Patients with epilepsy who want to pursue medical marijuana should consult their physicians. About 30 percent of epilepsy patients have treatment-resistant epilepsy. This is despite conventional treatment options and medications. It makes sense that many patients are eager to find a better option and look to CBD oil as a potential fit. It is recommended that patients consult with a specialized epilepsy center for a thorough evaluation. This will ensure that other possible treatments of epilepsy are tried before using medical marijuana.
If you have any history of adverse reactions with cannabis, you should consider the potential pros and cons of using it. Make sure to tell your doctor if you have ever had any adverse reactions to cannabis in the past. They can consider this when making prescription decisions.
Can Medical Marijuana or CBD Replace Other Seizure Medications?
Patients should never stop taking medications without first checking with their health care providers. In some instances, study participants using CBD were able to be weaned off of other medications. This was under strict medical supervision and was not true for every participant. Proper medical supervision is necessary before ever considering ceasing a seizure medication. Like other medications, Epidiolex is not for every patient and may not work well for some. Physicians are in the position to decide whether medications are working well with their patients’ feedback.
What if My Health Care Provider Refuses to Prescribe Medical Cannabis or CBD?
Controlling seizures can, unfortunately, be a trial-and-error process. Some treatments that work well for certain patients do nothing for others or can even be harmful. Prescribing doctors consider patients’ overall health, current medication regimen, medical history, and seizure control. Health care providers are in the best position to figure out whether medical marijuana or CBD will bring more benefits than risks for your situation.
Your physician may not feel comfortable recommending medical cannabis. Do not alter your treatment plan without first alerting them. There is always the possibility of seeking a second opinion from another provider. Nevertheless, CBD should always be taken under the supervision of a medical professional. This helps patients keep better track of their symptoms, as well as helping doctors spot potential problems very early.
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