Epidiolex Review 2021

The popularity of CBD products has increased in recent years. This is because experts are gradually recognizing the benefits it provides to people with issues such as insomnia, chronic pain, or anxiety. Moreover, the invention of medicines like Epidiolex has further established its legitimacy in healthcare. 

Epidiolex is not a regular CBD product. It’s actually a prescription drug that has been approved to treat seizures associated with various health conditions. In this Epidiolex review, we discuss all you need to know about the medicine: how it should be taken and what side effects it can cause. 

All About Epidiolex

Epidiolex, first produced by Greenwich Biosciences Inc, Carlsbad, CA, has revolutionized the treatment of medically refractory seizures in patients with any of three major health conditions. 

On 25 June 2018, it became the first plant-derived, purified pharmaceutical CBD medication to be approved by the FDA. It has been approved to treat seizures associated with LGS (Lennox-Gastaut syndrome), Dravet syndrome, and TSC (tuberous sclerosis complex) in patients aged 1 year and above. 

Now, given that it is a prescription CBD drug, you might have a lot of questions regarding what it is and how it functions. Let’s address some of those technicalities first. 

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1) Does It Contain THC?

The medicine contains CBD but no THC. Why does that matter? Well because a lot of people might have second thoughts about using the medication since it is derived from cannabis. 

While both CBD and THC are phytocannabinoids that are considered to be effective in their role for pediatric epilepsy [1], THC is the psychoactive component of marijuana (i.e. the component that gets you “high”). In the absence of THC, the non-psychoactive component, CBD causes significantly fewer psychoactive side effects while still reducing seizure frequency. 

2) Is It a Controlled Substance?

A controlled substance is a drug that can create dependence (one of the stages of addiction) or can be misused, and hence is regulated by the federal government. 

When Epidiolex came out for the first time in 2018, it was considered to be a controlled substance. However, since April 2020, it is not considered a controlled substance anymore under the federal Controlled Substances Act. [2]

This means that you don’t need any permit to use the medicine if you simply have a prescription from your physician. It has also made it easy for doctors to prescribe the medication and for patients to easily transfer their prescription from one pharmacy to another if needed. 

3) Epidiolex Cost in the UK

Epidiolex was approved for use in Europe in September 2019. Originally, NICE (National Institute for Health and Care Excellence) stated that it was not worth the high cost (between £5,000 and £10,000 per patient per year). However, Greenwich Pharmaceuticals had agreed with the NHS to lower the price. [3]

Epidiolex Side Effects

As we have mentioned several times in this Epidiolex review, this medicine is a prescription drug. Your doctor will certainly discuss several aspects of your health before prescribing it. On their official website, the brand specifically talks about the safety indications and side effects, which can range from mild to severe. 

Firstly, you should always check the ingredients of the product to look out for allergies. For example, the medicine uses sesame seed oil, so if you are allergic to sesame seeds, you should not take it. 

Secondly, Epidiolex may cause liver issues, especially if you are already vulnerable. Your doctor might take certain tests to check the condition of your liver before prescribing Epidiolex. 

Most common Epidiolex side effects

  • Sleepiness
  • Decreased appetite
  • Fever
  • Diarrhoea, vomiting
  • Skin rash
  • Insomnia
  • General weakness
  • Infections 

You should contact your doctor if you face any of these side effects. In the more severe cases listed below, you should seek help immediately.

Severe Epidiolex Side Eeffects

  • Diarrhoea, nausea, vomiting, loss of appetite
  • Fever, exhaustion
  • Yellowing of the skin or the whites of the eye (Jaundice)
  • Itching, rashes, or any other allergic reaction
  • Liver issues (pain in the upper-right area of the stomach, dark-coloured urine, diarrhoea)
  • Loss of coordination, sedation, suicidal thoughts, or behaviour

It is essential to note that any prescription drug should be used with caution. You should keep a few things in mind if you are facing any of the side effects.

  • Always contact your doctor first: If you are facing any of the side effects it is always wise to call your doctor right away. Discontinuing a seizure medicine can suddenly cause serious issues; don’t stop taking the medicines without consulting your doctor. However, in severe cases, call emergency immediately.
  • Epidiolex works with other medication: Epidiolex can affect how other medicines work and vice versa. So, do not stop or start other medications without talking to your healthcare provider. Let them know whatever you intake: prescription drugs, vitamins, cannabis-based products, and supplements. 
  • For pregnant women: Epidiolex can have a serious impact on unborn babies. If you are pregnant, your doctors and you should decide how to proceed with the medicine. If you get pregnant while taking the drug, contact your physician for further guidance. You should also discuss the matter of breastfeeding with them since the medicine is passed into breast milk. 

This medicine, despite its benefits, does have significant side effects. Additionally, long exposure to Epidiolex can cause liver issues in most patients. Research has shown that between 8 to 25% of people taking the medicine had high levels of liver enzymes [4].

Efficacy

On the website of Epidiolex, you will find the following success statistics for TSC-related seizures in a study with 200 test subjects:

  • Seizures reduced by 48% in patients with TSC-associated seizures taking Epidiolex (dose: 25 mg/kg/day) compared to the 24% in patients taking a placebo. 
  • 5% of people taking Epidiolex achieved freedom from TSC-associated seizures compared to 0% of people taking placebo.
  • 19% of people with TSC had their seizures reduced by 75% or more with the help of Epidiolex. 

As for LGS:

  • Epidiolex reduced drop seizures by 37% in one group (Dose: 10mg/kg/day) and by 42% in another (Dose: 20mg/kg/day) compared to a 17% in the placebo group.

And lastly, for Dravet syndrome:

  • Monthly convulsive seizures reduced by 39% in those taking Epidiolex (Dose: 20 mg/kg/day) compared to 13% in the placebo group.

However, as any other Epidiolex review would tell you, overall, the medicine seems to help out a pretty large group of people who could not find help in any other traditional pharmaceutical seizure medicines. Currently, the medicine can only be used to treat the three specific conditions we discussed, but it has certainly legitimized cannabinoids for healthcare. 

Following the recent approval of this drug, studies have been undertaken to find other ways Epidiolex can be used- be it for chronic pain, anxiety, migraine, multiple sclerosis, or various mental health issues[5].

Closing Thoughts

Being the first FDA-approved CBD prescription medication is a huge leap for cannabinoids since the journey to the widespread therapeutic use of CBD has been a long and tiring one. However, Epidiolex has been successful in furthering the research and development of medicine from cannabinoids. With research still going on and people being more and more open-minded about cannabinoids in general, there is a lot to hope for.