GLP-1 Receptor Agonists in Brazil: Landscape of Consumption, Safety and Regulation.

BACKGROUND

The escalating use of Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) is reshaping pharmaceutical consumption patterns and posing unprecedented challenges to healthcare systems worldwide. This study analyzes the landscape of GLP-1 RA consumption, safety monitoring and regulatory oversight in Brazil.

METHODS

A retrospective regulatory surveillance study was carried out triangulating data from three official sources: (1) national sales covering 2020-2024, classifying according to Anatomical Therapeutic Chemical (ATC) system; (2) adverse event reports submitted to Vigimed, the national pharmacovigilance platform integrated with global VigiBase; and (3) official alerts of falsified products. Sales data were sourced from industrial reports and the National System for the Management of Controlled Products (SNGPC).

RESULTS

Semaglutide emerged as the predominant GLP-1 RA in the Brazilian market. Consumption was markedly concentrated in regions with higher Gross Domestic Product (GDP), revealing a disconnect between medication use and regional diabetes prevalence. Pharmacovigilance analysis uncovered a significant proportion of reports involving off-label use, pointing to potential clinical and regulatory gaps. Furthermore, documented cases of counterfeit products underscore critical supply chain vulnerabilities.

CONCLUSION

The convergence of escalating demand, widespread off-label use and product falsification requires a coordinated and agile regulatory response. The observed trends suggest significant access disparities driven by economic factors rather than epidemiological need.