| アブストラクト | 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. |
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| ジャーナル名 | Diabetes, obesity & metabolism |
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| Pubmed追加日 | 2026/3/9 |
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| 投稿者 | Hurtado, Renato Lopes; Amato, Angelica Amorim; de Luca Correa, Hugo; Silveira, Damaris |
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| 組織名 | Agencia Nacional de Vigilancia Sanitaria (Anvisa), Brasilia, Brazil.;University of Brasilia, Brasilia, Brazil.;Catholic University of Brasilia, Brasilia, Brazil. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41796096/ |
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