Epidiolex contains cannabidiol, a chemical component of marijuana. The medication does not contain tetrahydrocannabinol, marijuana’s primary psychoactive component that causes the common “high.”
With the drug, seizures from epilepsy disorders Lennox-Gastaut syndrome and Dravet syndrome can be better controlled and “have a profound impact” on patients’ quality of life, FDA division of neurology products director Billy Dunn said Monday.
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Researchers studied Epidiolex’s effectiveness in three randomized, double-blind, placebo-controlled clinical trials with a total of 516 patients, all of whom suffered with one of the two epilepsy conditions.
Common side effects of Epidiolex, according to the FDA, include:
- elevated liver enzymes
- decreased appetite
- malaise and weakness
- sleep disorder/poor quality sleep
The most serious risks of the drug include thoughts of suicide, aggression, panic attacks, depression (new or worsening) and agitation. Side effects may also raise possibility of rare but more severe livery injury.
Learn more about the FDA approval of Epidiolex at fda.org.