JAMA Network Open · 9 authors, 10 centres
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This systematic review and meta-analysis of randomized controlled trials found that patients with epilepsy using cannabidiol had significantly higher risks of adverse events overall, severe adverse events, serious adverse events, and adverse events leading to discontinuation or dose reduction compared with placebo. Specific adverse events with significantly increased risk included somnolence, diarrhea, decreased appetite, and ALT or AST elevation.
The authors included randomized controlled trials and found that the frequency of any grade AEs was more than 2 times higher in patients receiving CBD compared with controls. The risks of any grade AEs, severe grade AEs (RR, 3.39), serious AEs (RR, 2.67), AEs leading to discontinuation (RR, 3.95), and AEs leading to dose reduction (RR, 9.87) were all significantly higher in the CBD group. Specific AEs with significantly increased incidence included somnolence, diarrhea, decreased appetite, and ALT or AST elevation. The study noted that moderate somnolence was significantly higher than in the control group (RR, 3.62) and that concomitant clobazam use was associated with somnolence in most studies, likely related to drug-drug interactions increasing N-desmethyl clobazam exposure. Limitations included substantial heterogeneity in study populations regarding age, disease severity, CBD dosage, and route of administration. Only AEs reported in at least 3 studies were included in the meta-analysis, and subgroup analyses by epilepsy type, dose, or treatment duration could not be performed due to limited data.
