Pharmacovigilance of Cannabis-Based Products in Brazil
Author(s)
Mariana Dias Lula, MSc1, Ronaldo Portela, PharmD, PhD2, Maria Laura Silva, PharmD, PhD3, Augusto Afonso Guerra Júnior, PhD1, Cristina Mariano Ruas, MS, MSc, PhD1.
1Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, 2Secretaria da Saúde do Distrito Federal, Brasília, Brazil, 3University of Bordeaux INSERM U1219, Bordeaux, France.
1Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, 2Secretaria da Saúde do Distrito Federal, Brasília, Brazil, 3University of Bordeaux INSERM U1219, Bordeaux, France.
OBJECTIVES: In recent years, the use of cannabis-based products for medical purposes has grown in Brazil, especially after their regulation by the Brazilian Health Regulatory Agency (ANVISA) in 2015. As with any other medicine, cannabis products are subject to pharmacovigilance, and adverse drug reactions (ADRs) must be reported to the National Health Surveillance System. This study aimed to describe ADRs potentially related to cannabis-based products recorded in the Brazilian pharmacovigilance database (VigiMed).
METHODS: This was a descriptive quantitative study using open data from ANVISA’s passive pharmacovigilance system. All ADR reports involving cannabis-based products between June 2020 and June 2024 were included. ADRs were classified according to the System Organ Class (SOC) of the Medical Dictionary for Regulatory Activities (MedDRA). Descriptive analyses were conducted using R software.
RESULTS: A total of 157 reports involving cannabis-based products were identified, comprising 772 reported ADRs. Of these, 305 (39.5%) were classified as serious. The most frequently reported SOCs were: nervous system disorders (17.9%), general disorders and administration site conditions (13.5%), and psychiatric disorders (11.9%). Additionally, 10.9% of ADRs were classified as injuries, poisoning, and procedural complications, and 8.4% as gastrointestinal disorders.
CONCLUSIONS: A significant number of serious ADRs were associated with the use of cannabis-based products, which may compromise patient safety, adherence to treatment, and health outcomes, as well as impact healthcare services. These findings underscore the importance of continuous monitoring of the safety profile of these products, including active pharmacovigilance strategies and therapeutic follow-up of users in the Brazilian context.
METHODS: This was a descriptive quantitative study using open data from ANVISA’s passive pharmacovigilance system. All ADR reports involving cannabis-based products between June 2020 and June 2024 were included. ADRs were classified according to the System Organ Class (SOC) of the Medical Dictionary for Regulatory Activities (MedDRA). Descriptive analyses were conducted using R software.
RESULTS: A total of 157 reports involving cannabis-based products were identified, comprising 772 reported ADRs. Of these, 305 (39.5%) were classified as serious. The most frequently reported SOCs were: nervous system disorders (17.9%), general disorders and administration site conditions (13.5%), and psychiatric disorders (11.9%). Additionally, 10.9% of ADRs were classified as injuries, poisoning, and procedural complications, and 8.4% as gastrointestinal disorders.
CONCLUSIONS: A significant number of serious ADRs were associated with the use of cannabis-based products, which may compromise patient safety, adherence to treatment, and health outcomes, as well as impact healthcare services. These findings underscore the importance of continuous monitoring of the safety profile of these products, including active pharmacovigilance strategies and therapeutic follow-up of users in the Brazilian context.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH179
Topic
Epidemiology & Public Health, Real World Data & Information Systems
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
No Additional Disease & Conditions/Specialized Treatment Areas