(RxWiki News) The US Food and Drug Administration (FDA) has approved a new indication for a drug that is derived from the Cannabis sativa plant.
This medication is found under the name Epidiolex (cannabidiol) [CBD].
Cannabidiol was actually approved back in June 2018 as a treatment for seizures tied to Lennox-Gastaut syndrome and Dravet syndrome in patients who are 2 years old and older.
This approval made cannabidiol the first FDA-approved drug that contained a purified drug substance derived from marijuana.
Furthermore, it was the first FDA approval for a treatment for Dravet syndrome.
Now, cannabidiol has been approved as a treatment for seizures linked with tuberous sclerosis complex (TSC) in those who are 1 year old or older.
This approval makes cannabidiol the second FDA-approved treatment for seizures associated with TSC.
TSC, a rare genetic disease, causes non-cancerous tumors to grow in the brain and other parts of the body. It can lead to seizures.
Epidiolex is available in an oral solution form and is dosed by weight. The recommended dose is 12.5 mg/kg twice daily. This dose is to be reached by increasing the dose weekly as the patient can tolerate the dose increase.
CBD is a chemical component of the Cannabis sativa plant. It is important to note that CBD does not cause one to feel “high” because CBD is not the same as tetrahydrocannabinol (THC).
THC (and not CBD) is the primary psychoactive component of marijuana. That means it's the component that causes the feeling of being “high.”
Common side effects of Epidiolex included decreased appetite, sleepiness, fever and diarrhea/vomiting. Furthermore, this medication was shown to increase liver enzymes.
This medication is to be dispensed with a patient Medication Guide.
A potential serious side effect is the risk for suicidal behavior and thoughts. It is important for patients, caregivers, and family members to monitor for changes in mood or behavior, such as worsening depression, anxiety, aggressiveness or suicidal thoughts. Such changes should be reported to the patient's health care provider.
Tell your health care provider about all the medications you take, including prescription medicines, over-the-counter drugs and herbal supplements, as this medication has the potential to interact with many medications.