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| Autori principali: | , , , |
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| Natura: | Artículo Open Access |
| Pubblicazione: |
Wiley
2026
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| Soggetti: | |
| Accesso online: | https://onlinelibrary.wiley.com/doi/10.1002/oby.70176 |
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Sommario:
- Evaluating the Evolving Real‐World Adverse Events of GLP ‐ 1RAs Using FDA Adverse Event Reporting System ( FAERS ) David Stone Mary Playdon Stephen D. Hursting Aik Choon Tan Obesity ABSTRACT Objective This study aimed to assess the spectrum and frequency of adverse events (AEs) linked to glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) using the US FDA Adverse Event Reporting System (FAERS). Emphasis was placed on emerging safety concerns in context‐specific use. Methods A retrospective analysis of FAERS reports between 2012 and 2025 was conducted. Five commonly prescribed FDA‐approved GLP‐1RAs were included. Disproportionality analyses were applied to detect AE signals. Subgroup analyses evaluated associations by indication, GLP‐1RAs compared to other drugs, and AEs specific to individual GLP‐1RAs. Results From over 18 million FAERS reports, 137,451 involved GLP‐1RAs. The most frequent AEs were gastrointestinal, nutritional and metabolic, and psychiatric disorders, occurring at higher rates compared to other drugs. In diabetes use, GLP‐1RAs were associated with retinopathy, hearing loss, and cataracts. In contrast, when prescribed for weight management/obesity, nutritional, metabolic, and psychiatric AEs predominated. We also developed an open‐access portal for AE exploration, available at http://glp1.tanlab.org . Conclusions GLP‐1RAs are linked to a broad range of AEs across indications. These findings stress the need for careful clinical monitoring and long‐term safety evaluation. This study also illustrates how real‐world evidence can inform safety communications, as well as hypothesis generation for research on next‐generation GLP‐1RAs. 10.1002/oby.70176 http://creativecommons.org/licenses/by/4.0/