FDA has approved Epidiolex, which contains a purified form of the drug substance cannabidiol (CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. That means the FDA has concluded that this particular drug product is safe and effective for its intended use.
FDA-approved synthetic THC formulations have a product label that explains their side effects and ) are indicated for the treatment of nausea and vomiting associated with cancer chemotherapy treatment; dronabinol is also indicated for the treatment of anorexia associated with weight loss in patients with AIDS.13-15
The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for nausea associated with cancer chemotherapy and for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive intoxicating component of cannabis (i.e., the component responsible for the “high” people may experience from using cannabis). Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived. Cesamet, like dronabinol-containing products, is indicated for nausea associated with cancer chemotherapy.
Why do synthetic cannabinoids pose such significant threats to public health?
They are not necessarily the same number of deaths as there are for other drugs of abuse, but we do see a large number of deaths related to synthetic cannabinoid use, where toxicology findings may only indicate that synthetic cannabinoids are present and no other drugs.