Cannabinoids and Adverse Convulsive Effects: A Pharmacovigilance and Addictovigilance Analysis of Cases Reported in France

IF 2.1 4区医学 Q3 PHARMACOLOGY & PHARMACY

Fundamental & Clinical Pharmacology Pub Date : 2025-06-20 DOI:10.1111/fcp.70028

Marie-Laure Laroche, Marion Labetoulle, Emilie Jouanjus, Edeltraut Kröger, Arsène Zongo

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引用次数: 0

Abstract

Background

Seizures after the use of cannabinoids are reported, but no precise descriptions of the characteristics of subjects and factors that may trigger seizures are available.

Objectives

To study the characteristics and circumstances associated with the occurrence of seizures in individuals using cannabinoids for medical or recreational purposes.

Methods

A retrospective analysis of spontaneous reports of adverse drug effects issued by the French pharmacovigilance and addictovigilance systems, and by manufacturers, extracted data from the Eudravigilance database (01/01/1985–21/07/2023). The request used the broad MedDRA SMQ term ‘convulsive’, with all products containing cannabinoids (THC, CBD, cannabis or natural cannabinoids).

Results

Among 4296 notifications with cannabinoids, 130 (3%) reports of convulsive effects were analysed: 29 cases (23.3%) related to medical use (27 CBD, 1 THC and 2 combined THC/CBD preparations) and 98 (75.4%) related to recreational use. The median age was 29.0 years (min-max: 3–75), 78.7% were men and 81.1% were serious cases. Among the recreational users, 38.8% used Cannabis sativa with a history of epilepsy, and 68.4% of them were taking antiepileptics. In total, 67.7% of individuals had at least one risk factor for seizures, i.e., 31.0% among medical users and 78.6% among recreational users. The main risk factors with medical use were inefficacy of CBD (17.2%), fatigue (13.8%) and concomitant epileptogenic medications (10.3%). The main risk with recreational use was concomitant epileptogenic medications (39.8%), consumption of illicit drugs (33.7%) and alcohol (32.7%).

Conclusion

This analysis demonstrates the importance of alerting cannabinoid users, particularly recreational cannabis users and those with a history of epilepsy, about seizure-associated risks. Moreover, educational information should be provided together with the prescription of licensed cannabinoids and medical cannabis.

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大麻素和不良惊厥效应：法国报告的病例的药物警戒和成瘾警戒分析

背景：使用大麻素后癫痫发作的报道，但没有准确的描述对象的特征和可能引发癫痫发作的因素。目的研究以医疗或娱乐为目的使用大麻素的个体癫痫发作的特征和相关情况。方法从Eudravigilance数据库（1985年1月1日- 2023年7月21日）中提取数据，对法国药物警戒系统和成瘾警戒系统以及生产商发布的药物不良反应自发报告进行回顾性分析。该请求使用了广义的MedDRA SMQ术语“惊厥”，所有产品都含有大麻素（四氢大麻酚、CBD、大麻或天然大麻素）。结果在4296例大麻素通报中，分析了130例（3%）惊厥效应报告：29例（23.3%）与医疗用途（27例CBD、1例THC和2例THC/CBD联合制剂）有关，98例（75.4%）与娱乐用途有关。中位年龄29.0岁（最小-最大3-75岁），男性占78.7%，重症占81.1%。在娱乐性大麻使用者中，38.8%的人有癫痫史，68.4%的人服用抗癫痫药物。总的来说，67.7%的人至少有一种癫痫发作的危险因素，即，31.0%的医疗使用者和78.6%的娱乐使用者。医疗使用的主要危险因素是CBD无效（17.2%）、疲劳（13.8%）和伴随的致癫痫药物（10.3%）。娱乐性用药的主要风险是同时服用致癫痫药物（39.8%）、非法药物（33.7%）和酒精（32.7%）。结论：该分析表明，提醒大麻素使用者，特别是娱乐性大麻使用者和有癫痫史的人有关癫痫相关风险的重要性。此外，应在提供有执照的大麻素和医用大麻处方的同时提供教育信息。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Fundamental & Clinical Pharmacology 医学-药学

CiteScore

5.30

自引率

6.90%

发文量

111

审稿时长

6-12 weeks

期刊介绍： Fundamental & Clinical Pharmacology publishes reports describing important and novel developments in fundamental as well as clinical research relevant to drug therapy. Original articles, short communications and reviews are published on all aspects of experimental and clinical pharmacology including: Antimicrobial, Antiviral Agents Autonomic Pharmacology Cardiovascular Pharmacology Cellular Pharmacology Clinical Trials Endocrinopharmacology Gene Therapy Inflammation, Immunopharmacology Lipids, Atherosclerosis Liver and G-I Tract Pharmacology Metabolism, Pharmacokinetics Neuropharmacology Neuropsychopharmacology Oncopharmacology Pediatric Pharmacology Development Pharmacoeconomics Pharmacoepidemiology Pharmacogenetics, Pharmacogenomics Pharmacovigilance Pulmonary Pharmacology Receptors, Signal Transduction Renal Pharmacology Thrombosis and Hemostasis Toxicopharmacology Clinical research, including clinical studies and clinical trials, may cover disciplines such as pharmacokinetics, pharmacodynamics, pharmacovigilance, pharmacoepidemiology, pharmacogenomics and pharmacoeconomics. Basic research articles from fields such as physiology and molecular biology which contribute to an understanding of drug therapy are also welcomed.