FDA-Approved Cannabis-Derived Drug for Seizures
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“Epidiolex is a very important part of the overall anti-seizure medication armamentarium — especially for patients with Dravet syndrome and Lennox-Gastaut syndrome, both very severe epilepsies with somewhat limited choices of treatments,” says Sudha Kilaru Kessler, MD, a pediatric neurologist in the division of neurology and the program director for both the Child Neurology Residency and the Pediatric Epilepsy Fellowship at Children’s Hospital of Philadelphia.
How Effective Is Epidiolex?
Both Lennox-Gastaut syndrome and Dravet syndrome are “refractory” forms of epilepsy, meaning medicines don’t work well to control attacks, and patients are less likely to be seizure-free even after trying multiple medications.
“In my personal experience, Epidiolex is not a cure or a miracle drug, but it has been very helpful in some patients for a while,” says Dr. Kessler. “It doesn’t make the problem go away, but it can keep seizures from happening when you’re on it.”
She warns, however, that the efficacy of Epidiolex, as with many anti-seizure medications, may wear off a bit over time.
How Is Epidiolex Different From the CBD You Buy Online or at a Retail Shop?
Nowadays, products containing CBD (cannabidiol) seem to be everywhere — in gummies, lotions, oils, and many other items.
CBD is a compound that can be derived from either the hemp or marijuana plant but is not psychoactive, like THC (tetrahydrocannabinol), another substance commonly associated with marijuana, which creates a “high” sensation.
Angela Birnbaum, PhD, a professor in the department of experimental and clinical pharmacology at the University of Minnesota in Minneapolis, suggests that because of all the hype surrounding CBD, some epilepsy patients may be tempted to experiment with products available through retail channels.
She warns, however, that these CBD products are not FDA approved, so there is little or no assurance of effectiveness or information regarding dosing and side effects.
“Without FDA approval, it’s difficult to identify the safety of a product, which would include purity as well as contents of impurities such as pesticides and other substances that may be added,” says Dr. Birnbaum.
The FDA continues to be concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA.
Possible Side Effects of Epidiolex
People with epilepsy who are taking CBD products, including Epidiolex, need to be aware of how CBD might interact with other anticonvulsants, such as levetiracetam, divalproex, topiramate, zonisamide, ethosuximide, and clobazam.
Certain drug combinations may be more likely to cause sedation, and patients are advised to consult with their doctor when taking multiple medications.
Overall, Epidiolex (which is manufactured by GW Pharmaceuticals) has a favorable safety profile with notable side effects being the risk of liver enzyme elevations, appetite changes, diarrhea, somnolence (sleepiness), pyrexia (fever), and fatigue.
Dosing and Cost of Epidiolex
Epidiolex is an oral solution that ranges from clear and colorless to yellow in color, with a strawberry flavor.
“Epidiolex is an important part of the whole palette that we have to use to treat these types of epilepsy,” says Kessler. “It’s really best to work with a physician who knows about the medications to get the best care for somebody with epilepsy.”
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