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FDA-Approved CBD and Why it Matters for Treating Epilepsy

As cannabidiol (CBD) is becoming less stigmatized, there’s been an explosion of CBD products available on shelves and online. CBD is a compound found in the cannabis plant, though it lacks the “high” associated with marijuana. Some people are hoping to access its benefits to manage a range of ailments. For those living with 3 rare forms of epilepsy, FDA approved CBD has been proven to effectively reduce seizures. So if you’re looking to use CBD for yourself or your child, how do you know which products have been evaluated for safety and effectiveness so you understand exactly what you’re getting? The FDA plays a key role in evaluating the safety and efficacy of products, and EPIDIOLEX® (cannabidiol) is the only FDA-approved CBD medicine used to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients one year of age and older.

IMPORTANT SAFETY INFORMATION

Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX.

Please refer to the EPIDIOLEX Medication Guide and Instructions for Use for additional important information.

Please see additional Important Safety Information & Indications below. Advertisement

FDA-approval matters because, despite its rise in popularity, CBD has flown somewhat “under the radar” when it comes to regulating its safety and effectiveness, manufacturing protocols, and accuracy of what the attached labels claim is in the product. Since 2016, the Food and Drug Administration (FDA) has issued over 90 warning letters to CBD manufacturers making false claims about the therapeutic benefits of CBD products available on-line and at dispensaries. Ingredient listings on these non-FDA approved CBD products can also be unreliable. A 2017 study in the Journal of the American Medical Association (JAMA) found that almost 70% of CBD products sold online did not contain the amount of CBD stated on the package. In 2021, a study that raised the same concerns additionally found some CBD products were contaminated with toxins like lead.

Unregulated CBD products may be risky for many reasons. For one, without oversight from the FDA, it’s nearly impossible to know how much CBD is actually in the product, or even if the ingredients listed are consistent from batch to batch. This lack of quality and consistency standards can affect the product’s effectiveness, making it a risky choice for people wanting to use CBD to treat serious medical conditions like epilepsy. 

Secondly, it’s important to be mindful of potential side effects and interactions with other medications. The safety profile of FDA-approved EPIDIOLEX was thoroughly studied in clinical trials, so the potential safety risks and drug interactions have been characterized. EPIDIOLEX may cause liver problems, sleepiness, suicidal thoughts or actions in a very small number of people. Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX. This information is not known for non-FDA approved CBD products, which can pose unknown and potentially serious safety risks, especially for people who are on multiple medications for conditions such as difficult-to-treat epilepsy.

Quality control for EPIDIOLEX starts in the greenhouse. Each cannabis plant is bred to yield high levels of CBD, and is grown in carefully prepared soil which contains no heavy metals, no pesticides, no contaminants and no genetic modification. After the plants have been harvested, scientists follow a strict multi-step process to turn the raw material into highly purified CBD. The product then passes through a series of strict quality controls set by the FDA to ensure its consistency and stability, and to guarantee it’s free from contaminants. The FDA approved EPIDIOLEX after meticulous review of the products safety and efficacy data. With EPIDIOLEX, you know exactly what you’re getting, and this transparency includes information about potential risks and side effects. Unlike other CBD products, EPIDIOLEX underwent extensive research, including multiple clinical studies in which the efficacy and safety profile was thoroughly evaluated in patients.

EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.

You can only get FDA-approved medicine through a doctor’s prescription, which is an advantage for anyone who wants to use CBD to help with seizures. When you get a prescription for EPIDIOLEX, your doctor will work with you to find the right dosage, as well as help you monitor for and/or avoid any unwanted interactions if other medications are also being used. Getting FDA-approved CBD also means potential coverage from your insurance, along with additional resources and support every step of the way. 

Important Safety Information & Indications (continued)

What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?

EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX:

  • loss of appetite, nausea, vomiting
  • fever, feeling unwell, unusual tiredness
  • yellowing of the skin or the whites of the eyes (jaundice)
  • itching
  • 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 signs of depression or anxiety, thoughts about suicide or self-harm, feelings of agitation or restlessness, aggression, irritability, or other unusual changes in behavior or mood, especially if they are new, worse, or worry you.

If you are pregnant or plan to become pregnant, EPIDIOLEX may harm your unborn baby. You and your healthcare provider will have to 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 (by calling 1-888-233-2334). The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.

Because many medicines like EPIDIOLEX are passed into breast milk, talk to your healthcare provider about the best way to feed your baby while taking EPIDIOLEX.

Take EPIDIOLEX exactly as your healthcare provider tells you. Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping a seizure medicine suddenly can cause serious problems.

What Else Should I Know When Taking EPIDIOLEX?

The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.

EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.

What Additional Information Applies to Women?

If you are pregnant or plan to become pregnant, EPIDIOLEX may harm your unborn baby. You and your healthcare provider will have to 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 (by calling 1-888-233-2334). The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.

Because many medicines like EPIDIOLEX are passed into breast milk, talk to your healthcare provider about the best way to feed your baby while taking EPIDIOLEX.

What is EPIDIOLEX (cannabidiol)?

EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older.

It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.

Please refer to the EPIDIOLEX Medication Guide and Instructions for Use for additional important information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Jazz Pharmaceuticals at 1-833-424-6724.

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