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. 2024 Jan;38(1):74-81.
doi: 10.1002/ptr.8028. Epub 2023 Oct 6.

Pharmacovigilance of unlicensed cannabidiol in European countries

Fabrizio Calapai  1   2 , Emanuela Esposito  1 , Ilaria Ammendolia  1   2 , Carmen Mannucci  3 , Gioacchino Calapai  1 , Mariaconcetta Currò  2 , Luigi Cardia  4 , Ioanna Chinou  5
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Pharmacovigilance of unlicensed cannabidiol in European countries

Fabrizio Calapai et al. Phytother Res. 2024 Jan.

Abstract

Cannabidiol (CBD) is a multitarget agent possessing anti-inflammatory and antioxidant properties. Unlicensed CBD gained public favor for the care of general health and well-being as well as to get comfort from inflammatory complaints, pain, anxiety, mood, and sleep disorders. Safety profile of unlicensed CBD has been not sufficiently described. For this reason, suspected adverse reactions (SARs) to CBD unlicensed products were analyzed. Serious SARs to unlicensed CBD products in EudraVigilance, a system purchased by the European Medicines Agency, were analyzed for age, sex of the patient, adverse reactions, indication for use, and concomitant drugs. Serious SARs were 18.9% of all adverse events to unlicensed CBD; they were more frequent in men and adult people and, to a less extent, in children (3-11 years). About sex, in EudraVigilance serious Individual Cases Safety Reports of SARs to CBD in men are in the largest number (58.8%) with respect to women. Unlicensed CBD was used in the 38.8% of cases for treatment of epilepsy; more frequent adverse effects were: mental disorders, hepatic disorders, and aggravation of pre-existing epilepsy. Drugs or substances more frequently associated with SARs were the antiepileptics clobazam and valproic acid, followed by cannabis. Results suggest that precautions and appropriate surveillance of adverse effects should be taken when unlicensed CBD is used.

Keywords: EudraVigilance; adverse events; adverse reactions; cannabidiol; cannabis; pharmacovigilance.

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