What were the most common adverse effects associated with Epidiolex in the Antiepileptic Efficacy Study of GWP42003-P (Cannabidiol) in Children and Young Adults With Dravet Syndrome?
The more common side effects of cannabidiol were diarrhea, vomiting, fatigue, somnolence, lethargy and decreased appetite. Fever, upper respiratory tract infections and convulsive seizures were also reported more frequently than in the placebo arm (statistical comparisons for these adverse effects, CBD to placebo, were not provided by authors). Twenty percent of subjects in the CBD arm (n=12) also developed transaminitis. In 9 cases the transaminases normalized during continued use CBD, in the other 3 cases CBD was discontinued because of a transaminase > 3X ULN. Interestingly, in all cases of transaminitis the subject was also on valproic acid.
Devinsky O, Cross JH, Wright S. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017 Aug 17;377(7):699-700. doi: 10.1056/NEJMc1708349. PMID: 28813226
Submitted by: Michael Hodgman, MD on behalf of Herbal and Dietary Supplement Section