The FDA approves the first drug containing marijuana
- On June 25, the first ever drug containing CBD was approved in America.
- It is used to treat severe forms of epilepsy, such as Dravet's or Lennox-Gastaut syndrome.
As CBD-based drugs have entered the market, the agency promises action against manufacturers of cannabidiol products that cause side effects.
On June 25, 2018, the U.S. Food and Drug Administration first approved a marijuana-containing drug, Epidiolex, for the treatment of rare forms of epilepsy . Treatment contains cannabidiol or CBD and does not produce euphoria and at the same time reduces the rate of seizures in patients with Dravet's or Lennox-Gastraut's syndrome, according to clinical studies.
"In my practice, I often encounter patients with epilepsy that is highly resistant to treatment. Patients have tried existing therapies that have failed, so they ask about CBD, ”said Orrin Devinsky of NYU Langone Health, the lead investigator in the studies of the company that makes Epidiolex. "I am very happy for my colleagues. We will now be able to prescribe cannabidiol, which has undergone a strictly controlled study and has been approved by the FDA to treat both children and adults.
Dravet and Lennox-Gastaut syndrome
Both Dravet's and Lennox-Gastaut syndrome are relatively severe forms of epilepsy that can be fatal. While there are other drugs approved for the treatment of Lennox-Gastaut syndrome, there has not been any for Dravet syndrome. Some parents used untreated CBD oils to treat their children. In a published statement, the FDA states that “it has taken recent action against companies that distribute unapproved CBD products. We will continue to take action if we see illegal sales of CBD-containing products with unknown health effects.
"I'm really glad we have a much cleaner product that knows the composition," said AP Ellaine Wirrell, director of the Mayo Clinic for Pediatric Epilepsy. "In handmade products, there is often a huge difference in bottle-to-bottle dosage, depending on where you buy it."
Heather Jackson of Realm of Caring, the CBD charity CW Hemp, said: "I don't know if my father or mother will reconsider and change something that already works. I really don't think (FDA approval) will affect us in any way."
Source: article , image: fortune.com, secondnexus.com