Medical Cannabis Use in France: An Observational Safety Study Based on the RECANN Registry and the Pharmacovigilance/Addictovigilance System From 2021 to 2024

IF 2.7 4区医学 Q3 PHARMACOLOGY & PHARMACY

Fundamental & Clinical Pharmacology Pub Date : 2026-02-24 DOI:10.1111/fcp.70074

Cécile Chevallier, Anne Batisse, Emilie Monzon, Nathalie Richard, Nicolas Authier, Chouki Chenaf, Louise Gaboriau, Véronique Ferey, Basile Chretien, Sophie Fedrizzi, Marine Auffret

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引用次数: 0

Abstract

Introduction

The French National Agency for Medicines and Health Products Safety implemented in 2021 a nationwide experimentation for medical cannabis (MC), designed to assess the feasibility of implementing a new public health policy. A dedicated registry was established to support the notification of adverse drug reactions (ADRs). The objective of this study was to describe the safety data collected during the first 3 years of experimentation.

Method

Data related to MC use were extracted from the registry and the French pharmacovigilance and addictovigilance database between March 26, 2021, and March 31, 2024.

Result

Among the 3164 included patients, at least one ADR was reported in 1186 patients, including 81 patients (3%) with serious ADRs (SADRs). The most common ADRs were neurological (37.2%), gastrointestinal (16.9%), and psychiatric (15.2%). Among SADRs, six cases of acute coronary syndromes were reported, along with eight cases of suicidal thoughts including one suicide attempt. Half of these psychiatric events occurred in patients without a prior psychiatric history, and no cases of psychosis were documented. Regarding addictovigilance, only 12 ADRs were analyzed: seven withdrawal syndromes, three cases of tolerance, and two cases of THC-containing inflorescence misuse, including one case of MC use disorder.

Discussion

During the experimentation, 3% of patients treated with MC experienced at least one serious ADR. The safety profile was dominated by neurological, gastrointestinal, and psychiatric ADRs. Only one case of MC misuse was identified with inflorescences. This study is observational and non-comparative and cannot provide a comprehensive assessment of the risk associated with MC use.

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法国医用大麻使用：2021年至2024年基于RECANN注册和药物警戒/成瘾警戒系统的观察性安全性研究

前言：法国国家药品和保健产品安全局于2021年在全国范围内实施了一项医用大麻试验，旨在评估实施一项新的公共卫生政策的可行性。建立了专门的注册中心，以支持药物不良反应（adr）的通报。本研究的目的是描述前三年实验期间收集的安全数据。方法：从登记处和法国药物警戒和成瘾警戒数据库中提取2021年3月26日至2024年3月31日期间与MC使用相关的数据。结果：纳入的3164例患者中，1186例患者报告了至少一种ADR，其中严重ADR (SADRs) 81例（3%）。最常见的不良反应是神经系统（37.2%）、胃肠道（16.9%）和精神科（15.2%）。在sadr中，报告了6例急性冠状动脉综合征，以及8例自杀念头，包括1例自杀企图。这些精神事件中有一半发生在没有精神病史的患者身上，也没有记录在案的精神病病例。在成瘾警惕性方面，仅分析了12例不良反应：7例戒断综合征，3例耐受，2例含四氢大麻酚的花序滥用，包括1例MC使用障碍。讨论：在实验期间，3%的接受MC治疗的患者至少经历了一次严重的不良反应。安全性主要是神经系统、胃肠道和精神病学的不良反应。在花序上仅发现1例MC误用。这项研究是观察性的，非比比性的，不能提供与MC使用相关的风险的全面评估。

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.