The U.S. Food and Drug Administration has approved a marijuana-based drug for the first time, pacing the way for more research into an ingredient that is still illegal in federal law despite increasing legalization for medical and recreational purposes.
The drug, named Epidiolex, received unanimous recommendation from an FDA advisory committee in April. The approval comes as good news for the supporters of the drug, which is being used to treat children suffering from severe forms of epilepsy and seizures.
Here’s What You Need To Know About Epidiolex
The FDA approved the prescription of Epidiolex for patients 2 years old and older for the treatment of two forms of epileptic syndromes. The first is Dravet syndrome, which is a rare genetic dysfunction that starts within a child’s first year, and the second is Lennox-Gastaut syndrome, which is a form of epilepsy that causes multiple types of seizures usually starting from 3 to 5 years old.
The strawberry-flavored syrup is a purified form of cannabidiol or CBD, one of the more than 80 chemicals found in cannabis plants. However, unlike tetrahydrocannabinol or THC, it does not give people who take it a high.
It is unclear how CBD reduces the instances of seizures in people, but that was the result of studies carried out by GW Pharmaceuticals. The British drugmaker studied the effects of Epidiolex in over 500 patients suffering from hard-to-treat seizures, with positive results.
According to the FDA, Epidiolex reduced cases of seizures when taken in combination with older drugs used for epilepsy treatment.
The effectiveness of Epidiolex has forced parents who have children suffering from epilepsy to move to states where marijuana has been legalized. With the FDA approval, that will no longer be a requirement, though there are concerns that it will lead to the restriction of other cannabis products.
The Future Of Marijuana-Based Drugs
In a statement, FDA Commissioner Dr. Scott Gottlieb said that the approval of Epidiolex is “an important medical advance.”
“Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery,” Gottlieb added.
Gottlieb, however, noted that the approval for Epidiolex does not mean that marijuana and all of its components have also received approval. Only one specific CBD medication was approved, and only for a specific use.
The FDA, meanwhile, has opened the path for other drug developers who want to gain approval for marijuana-based medicine. This should mean that more drugs derived from marijuana should make their way through the FDA approval process in the near future
Generic Name: cannabidiol
Dosage Form: Oral Solution
Date of Approval: June 25, 2018
Company: GW Pharmaceuticals plc
Treatment for: Lennox-Gastaut Syndrome; Dravet Syndrome
How should I take Epidiolex?
- Read the Instructions for Use provided with your prescription for information on the right way to use Epidiolex.
- Take this medicine exactly as your healthcare provider tells you.
- Your healthcare provider will tell you how much to take and when to take it.
- Take Epidiolex about the same time each day consistently either with or without food.
- Measure each dose using the bottle adapter and 5 mL dosing syringes that come with Epidiolex. If your dose is less than 1 mL, your pharmacist will provide you with 1 mL syringes to take your medicine.
- Use a dry syringe each time you take your dose. If water is inside the syringe, it could cause the oil based medicine to look cloudy.
What should I avoid while taking Epidiolex?
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how Epidiolex affects you. Epidiolex may cause you to feel sleepy.
What are the ingredients in Epidiolex?
Active ingredient: cannabidiol
Inactive ingredients: dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose Epidiolex does not contain gluten (wheat, barley or rye).
Who should not take Epidiolex?
Do not take Epidiolex if you are allergic to cannabidiol or any of the ingredients. See the end of this Medication Guide for a complete list of ingredients.
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had depression, mood problems or suicidal thoughts or behavior.
- have liver problems.
- have abused or been dependent on prescription medicines, street drugs or alcohol.
- are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking Epidiolex. You and your healthcare provider will decide if you should take Epidiolex while you are pregnant.
- If you become pregnant while taking Epidiolex, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.
- are breastfeeding or plan to breastfeed. It is not known if Epidiolex passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Epidiolex.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any cannabis-based products.
Epidiolex may affect the way other medicines work, and other medicines may affect how Epidiolex works. Do not start or stop taking other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Tell your healthcare provider if you are planning to have a cannabis drug screen because Epidiolex may affect your test results. Tell the person giving the drug test that you are taking Epidiolex
Epidiolex can cause serious side effects, including:
- Epidiolex may cause liver problems. Your healthcare provider may order blood tests to check your liver before you start, and during treatment. In some cases, treatment may need to be stopped.
Call your healthcare provider right away if you develop any of these signs and symptoms of liver problems during treatment:
- loss of appetite, nausea, vomiting
- fever, feeling unwell, unusual tiredness
- yellowing of the skin or the whites of the eyes (jaundice)
- unusual darkening of the urine
- right upper stomach area pain or discomfort
- Epidiolex may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Epidiolex affects you.
- Like other antiepileptic drugs, Epidiolex may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempt to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
- Do not stop taking Epidiolex without first talking to your healthcare provider. Stopping a seizure medicine such as Epidiolex suddenly can cause you to have seizures more often or seizures that do not stop (status epilepticus). Call your healthcare provider between visits as needed, especially if you are worried about symptoms.