Whether you like the Food and Drug Administration (FDA) or not, formal approval of any medication in the United States is delivered by the FDA. While their processes have come under scrutiny numerous times, the FDA looks at research studies to decide if drugs should be approved for use for specific conditions.1
Recently, the FDA formally approved the first cannabis-derived product to be used in treating severe forms of epilepsy. Epidiolex™ (cannabidiol) was recently approved for the treatment of two forms of epilepsy that are rare: Lennox-Gastaut syndrome and Dravet syndrome. The medication is approved for use in patients who are over the age of two.2
There is no such thing as a medication/drug that does not have potential side effects. Medications alter the functioning of the individual’s system and this alteration can lead to imbalances of hormones, neurotransmitters, etc. that can result in side effects. Side effects occur on a probabilistic basis meaning that they will not definitely occur in everyone.
The common side effects that are associated with the use of Epidiolex™ include: 2, 3, 4
- decreased appetite,
- weakness or lethargy,
- problems with sleep,
- increased potential to develop infections,
- and transaminase elevations (which is a potential indicator of possible damage to the liver).
Other side effects include:
- New laboratory-defined anemia
Other cannabinoid-based medications approved by the FDA include:
- Marinol™ (dronabinol)5 is a synthetically-derived cannabinoid (it does not contain a plant-derived cannabinoid). It is approved for the treatment of weight loss and anorexia in patients with AIDS or because of chemotherapy. It may also have some utility in treating nausea in these patients. Some of the side effects reported include:
- Because the product contains sesame seed, people with allergies to sesame seeds should not use it.
- Heartbeat irregularities, low blood pressure, and other cardiovascular side effects
- Some individuals may develop depression or anxious reactions (e.g., panic attacks)
- Syndros™ (dronabinol)6 is another synthetically-derived cannabinoid medication with the same treatment recommendations as Marinol and essentially the same side effect profile.
- Cesamet™ (nabilone)7 is designed to treat chemotherapy-induced nausea and vomiting and is classified as an antiemetic drug. It too is a synthetically-derived substance that chemically resembles The drug has numerous potential side effects that can include:
- increased heart rate,
- alterations of mood that can range from depression, to severe anxiety, to euphoria,
- potential psychosis (hallucinations and/or delusions),
- a potential for abuse and the development of a substance use disorder.
A more comprehensive list of side effects and indications for use of the above medicines can be found in the reference section of this article (look at the link for each drug). The probability of experiencing the potential side effects of the substances or of any substances increased with increases in the dosage. Again, side effects from medications occur on a probabilistic basis and some people are more vulnerable than others depending on numerous potential risk factors.
- Food and Drug Administration. (2018). FDA and marijuana. Retrieved from: https://www.fda.gov/newsevents/publichealthfocus/ucm421163.htm.
- Food and Drug Administration. (2018). FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. Retrieved from: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm.
- Food and Drug Administration. (2018). Epidiolex cannabinol oral solution. Retrieved from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf.
- Food and Drug Administration. (2017). Marinol (dronabinol) capsules for oral use. Retrieved from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018651s029lbl.pdf.
- Food and Drug Administration. (2016). Syndros. Retrieved from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205525s000lbl.pdf.
- Food and Drug Administration. (2006). Cesamet (nabilone) Capsules. Retrieved from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018677s011lbl.pdf.