Unlicensed CBD products in Europe linked to liver problems and seizure worsening

Serious adverse reactions made up 18.9% of all reported events for unlicensed CBD. They were most common in men (58.8%) and adult age groups, with 38.8% of reports involving epilepsy treatment. The most frequent serious effects were mental disorders, hepatic disorders, and aggravation of pre-existing epilepsy. Clobazam and valproic acid were the most common co-administered drugs.

Analysis of serious suspected adverse reactions to unlicensed CBD products reported in EudraVigilance, the European Medicines Agency adverse event database. Reports were analyzed by age, sex, adverse reaction type, indication, and concomitant drugs.

With unlicensed CBD products widely available across Europe, this safety analysis reveals that serious adverse effects occur, particularly when CBD is used for epilepsy alongside other antiepileptic drugs. This underscores the risk of using unregulated CBD as a substitute for approved formulations.

The global CBD market includes many unregulated products with variable quality and purity. This European pharmacovigilance data shows that even a compound widely perceived as safe can produce serious adverse effects, especially when used alongside prescription medications without medical oversight.

Passive pharmacovigilance data has inherent reporting biases and likely underestimates true adverse event rates. Product quality and actual CBD content of unlicensed products are uncertain. Cannot establish causation from adverse event reports alone.