On June 25, 2018, the U.S. Food and Drug Administration (FDA) approved Epidiolex, a pharmaceutical-grade cannabidiol (CBD) oil. This non-intoxicating organic compound, extracted from cannabis, is the first FDA-approved drug with a purified substance stemming from marijuana.
As the popularity of legal cannabis has grown, so has further medical research into its purported benefits and the potential medicinal applications of its compounds. For example, emerging research has shown that CBD oil may have the potential to reduce or minimize the effects of medical conditions associated with epilepsy and psychosis.
Approved for the Treatment of Seizures
First approved for the treatment of seizures that occur with two severe and rare types of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, the drug has been deemed safe for patients ages two years or older. This is the first approval of its kind by the FDA for patients with Dravet syndrome.
The results of two studies involving the drug were released during August 2018. Epidiolex was first studied in three controlled, randomized, double-blind clinical trials. Patients participating in the study suffered from either Lennox-Gastaut syndrome or Dravet syndrome. When paired with other medications, Epidiolex was proven to be effective in reducing the frequency and severity of seizures compared to the placebo group.
A New Form of Relief for Patients
For many patients, CBD oil can lead to fewer and less severe episodes. The positive results to the drug derived from cannabis have proven to be a triumph for those with the formerly treatment-resistant syndromes. Medterra, a leading producer of lab tested CBD states that unlike cannabis, CBD does not trigger the “high” that is associated with tetrahydrocannabinol, otherwise known as THC. THC is known as the psychoactive component of marijuana. However, unlike Medterra’s product line, trace amounts of THC are found in Epidiolex CBD oil.
In addition to the treatment of seizures associated with Lennox-Gastaut and Dravet syndromes, CBD oil has also been successful at decreasing brain abnormalities in patients with psychosis. With conclusions drawn from a separate study, Epidiolex noticeably lessened psychotic behavior among the study’s patients.
What about non-Pharmacological CBD?
Given its growing mainstream acceptance and general legality in many geographic areas, research surrounding CBD oils, even those outside of the pharmaceutical world, is coming to light on a regular basis.
This surge in positive information surrounding the potential use of CBD oil to treat and/or mediate symptoms from a myriad of health issues is good news for businesses such as Medterra. Businesses like Medterra specialize in offering lab tested, pure and potent CBD oil to the public and stand to gain from the growing legitimacy of CBD oil in the health community.
Potential Adverse Effects of Treatment
Though Epidiolex has received largely positive responses, there are side effects as with most drugs. The most common side effects found during clinical trials include: drowsiness, sedation, lethargy, an increase in liver enzymes, decreased appetite, diarrhea, rash, fatigue, malaise, weakness, insomnia, sleep disorders or poor sleep quality and infections.
The drug must be accompanied by a patient Medication Guide that divulges necessary information about the risks and more serious side effects associated with Epidiolex as well as its uses. Like all other drugs for epilepsy treatment, the most serious risks of Epidiolex include thoughts about suicide, attempts of suicide, agitated feelings, new or more severe depression, aggression and panic attacks. Liver injury, though often mild, but sometimes severe injury can also occur when using Epidiolex. More severe liver injury may cause nausea, vomiting, abdominal pain, anorexia, jaundice and dark urine.
Most pharmaceutical drugs involve risks and side effects. A doctor’s examination, consideration of syndrome symptoms and treatment advice are vital to receive an Epidiolex prescription. Patients utilizing CBD oil should be aware of side effects and talk to a doctor should issues arise or worsen as a result of the medication.