Safety

SAFETY INFORMATION

The following information is important for all consumers to review, regarding the use of products containing cannabidiol (CBD).

As with all medication, supplements, or other products being used, including products containing CBD, it is recommended to review with your healthcare provider to make sure risks, benefits, and alternatives are discussed with you.

Liver toxicity

The FDA identified that with the use of higher doses of CBD to treat epilepsy with the FDA approved drug Epidiolex, some patients developed liver toxicity. Under medical supervision, this can be monitored and managed [1]. It is unknown to what extent, if any, there would be similar effects on liver function for those taking CBD in dosages far less than what is required to treat/manage epilepsy.

Drug Interactions

Cannabis (THC and/or Cannabidiol) as with many medications, supplements, or other products being used, carries a potential risk for interactions with how other medications you may take are metabolized. They can alter the efficacy of some medications and may also lead to concerns about the toxicity of various medications/drugs.

The following list of medications shares similar metabolism pathways as cannabis, and therefore the potential for interactions exists. This list is subject to additions or deletions as more knowledge is gathered [2].

  • Macrolides
  • Certain Statins
  • Carbamazepine
  • Calcium channel blockers
  • Ketoconazole/Itraconazole
  • Phenytoin
  • Benzodiazepines
  • Ritonavir
  • Haloperidol
  • Cyclosporine
  • Clarithromycin
  • Sildenafil (and other PDE5 inhibitors)
  • Phenobarbital
  • Antihistamines
  • Rifampicin

It is not clear at this time how clinically significant these interactions may be, how commonly they occur, and how prevalent they are with CBD as opposed to the psychoactive component of cannabis (THC).

Side Effects

It is not known what side effects if any, someone may experience when using CBD. Side effects which have been reported include but are not limited to:

  • Changes in alertness, most commonly experienced as somnolence (drowsiness or sleepiness).
  • Gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite.
  • Changes in mood, most commonly experienced as irritability and agitation [1].

Male Reproductive Toxicity

At this time, with studies done laboratory animals male reproductive toxicity has been demonstrated, including in the male offspring of CBD-treated pregnant females. As FDA public guidance has pointed out these findings were only seen in animals. It is not yet clear what these findings mean for human patients and the impact it could have on men (or the male children of pregnant women) who take CBD. Further testing and evaluation are needed to better understand this potential risk [1].

Pregnancy and Breastfeeding

There is no comprehensive research studying the effects of CBD on the developing fetus, pregnant mother, or breastfed baby. FDA is continuing to collect and study the data on the possible harmful effects of CBD during pregnancy and while breastfeeding. However, based on what we do know, there is a significant cause for concern [1].

The FDA in its public guidance report indicated that high doses of CBD in pregnant test animals have caused problems with the reproductive system of developing male fetuses. Also, based on what we already know about CBD, we expect that some amount of CBD will be transferred to babies through breast milk [3].

The FDA also indicated that there is a potential for CBD products to be contaminated with substances that may pose a risk to the fetus or breastfed baby, including THC. They have also heard reports of CBD potentially containing other contaminants (e.g., pesticides, heavy metals, bacteria, and fungus); they are investigating this [1].

Therefore, as with many medications, supplements, or other products used, it is not recommended that pregnant women, those trying to get pregnant, and anyone who is lactating/breastfeeding use any product containing CBD.

 

  1. Commissioner, Office of the. “What to Know About Products Containing Cannabis and CBD.” S. Food and Drug Administration, FDA, www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

 

  1. https://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/Medical%20Cannabis%20Adverse%20Effects%20and%20Drug%20Interactions_0.pdf

 

  1. Dalterio SL, deRooij DG. Maternal cannabinoid exposure. Effects on spermatogenesis in male offspring. Int J Androl. 1986 Aug;9(4):