The marijuana plant (Cannabis sativa) contains some 480 different substances, of which more than 100 are naturally occurring compounds called cannabinoids. Among the hundreds of cannabinoids, two compounds have been widely studied — delta-9-tetrahydrocannabinol (THC), a psychoactive substance, and cannabidiol (CBD), which is a psychoactive (a non-intoxicating substance). 

This article will talk about some cannabinoid-containing prescription medications that have received FDA approval. We will also discuss the risks of using products derived from the Cannabis sativa plant for recreational or medical purposes.

What’s the legal status of medical marijuana in the US?

As of April 2022, 37 states have legalized one or more components of the cannabis plant for use as medical cannabis. Additionally, with the passage of the 2018 Farm Bill, CBD oil, a hemp-derived extract, is legal, as long as the sourcing and manufacturing process adheres to specific federal and state regulations. However, the marijuana plant remains illegal at the federal level in the US. 

According to the Drug Enforcement Administration (DEA), marijuana is a Schedule I substance under the Controlled Substances Act. Schedule I substances have a high potential for abuse and currently have no accepted medical uses in the US. 

While some states in the US have legalized the use of marijuana for medical purposes, the U.S. Food and Drug Administration (FDA) is the federal regulatory agency that approves prescription drugs in the country. 

To date, the FDA has not approved marijuana or any marijuana product to treat any medical condition. The FDA and DEA state that marijuana has no federally approved medical use in the US, and it remains a Schedule I controlled substance under federal law. 

Has the FDA approved any prescription cannabinoid medications?

There is a great deal of interest in using cannabis to treat a range of medical conditions. Numerous clinical trials are underway as drug development researchers are studying the clinical benefits and the potential adverse effects of cannabis as a human drug. However, until now, the FDA has not approved cannabis (marijuana) to treat any medical condition or disease. 

The FDA has, however, approved the following cannabis-derived drugs. These are prescription drugs available only on the orders of a licensed healthcare provider. They work by binding to cannabinoid receptors in the central nervous system.

Cannabidiol (Epidiolex®)

This is the first FDA-approved drug that contains a purified form of cannabidiol (CBD). It is made by GW Pharmaceuticals and is used to treat seizures associated with Dravet syndrome or Lennox-Gastaut syndrome in patients 2 years of age and older. 

Dronabinol (Marinol® and Syndros®)

Dronabinol is a synthetic cannabinoid (active ingredient THC). It is available as an oral capsule (Marinol®) and oral solution (Syndros®). These medications cause appetite stimulation and are FDA approved to treat AIDS-related anorexia (AIDS patients with weight loss). They are also used to treat nausea and vomiting associated with cancer chemotherapy in adult patients who have not responded to traditional antiemetic treatments. 

Nabilone (Cesamet®)

Nabilone is a synthetic form of THC and is available as a capsule for oral ingestion. It is an FDA-approved drug to treat nausea and vomiting in adults undergoing cancer chemotherapy who have not responded adequately to conventional antiemetic treatments. 

Nabiximols 1:1 THC and CBD (Sativex®)

Nabiximols (Sativex®) is a 1:1 THC and CBD oral spray. It is an investigational drug in the US for HIV-associated neuropathic pain, polyneuropathy, advanced cancer pain, and palliative care. 

However, nabiximols is approved in more than 25 other countries for symptom improvement in adults with moderate to severe spasticity associated with multiple sclerosis. It is used to treat spasticity in adults with MS who have failed to respond adequately to other anti-spasticity medications and show clinical benefits in spasticity symptoms during an initial trial therapy with nabiximols. 

What are the risks of using cannabis-derived products?

It is important to understand that besides the prescription cannabinoids listed above, the FDA has not approved any other cannabis, cannabis-derived, or cannabidiol (CBD) products or dietary supplements that are currently available on the market. It is currently illegal to market CBD by adding it to food or labeling it as a dietary supplement.

Drug-Drug Interactions

One of the biggest concerns with using cannabis and cannabis extracts for recreational or medical uses is the potential for drug-drug interactions. Active metabolites in cannabinoid-containing products can interfere with the working of many other medications and potentially cause serious side effects. This is especially true for medicines with a narrow therapeutic index (NTI). NTI drugs have a very small difference in doses or blood levels that can either lead to therapeutic failure or severe adverse drug reactions.

For this reason, it is important to consult a healthcare provider and obtain accurate drug-drug interaction information before using any cannabis-derived products for recreational or unmet medical needs.

Side Effects

Based on available drug evaluation data, the FDA also warns that CBD can lead to elevated liver enzymes and liver injury. 

Using recreational cannabis with alcohol or certain other drugs that slow brain activity (for example, drugs used to treat panic attacks, anxiety, stress, and sleep disorders) can lead to sedation and drowsiness, increasing the risk of accidents and injuries. 

Animal studies have shown that exposure to CBD can cause fertility problems in males and issues in the male offspring of females exposed to CBD.

CBD can cause side effects such as drowsiness, sleepiness, reduced alertness, gastrointestinal symptoms like diarrhea and decreased appetite, and mood changes like agitation or irritation. Stopping the use of the product or dose adjustments usually results in an improvement in these symptoms.

Wrapping Up

CBD products are widely available and marketed as drugs, food, and dietary supplements. However, there are many important things that we just don’t know yet about products derived from the cannabis plant and how they affect the human body. 

Other than Epidiolex, which was approved by the FDA to treat a certain type of seizure disorder, there are other drugs that are used to treat pain and weight loss in AIDS patients, along with nausea and vomiting in cancer patients. The FDA has not approved any other over-the-counter CBD product. Until there is further data regarding the safety and efficacy of CBD products, you should always consult a healthcare professional before using any CBD products. 

References:

1. https://www.karger.com/Article/FullText/507998
2. https://medicalmarijuana.procon.org/pharmaceutical-drugs-based-on-cannabis/
3. https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process
4. https://www.dea.gov/sites/default/files/2020-06/Marijuana-Cannabis-2020_0.pdf
5. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis