Evaluation of the safety profile of glucagon-like peptide-1 receptor agonists: a focus on thyroid cancer-related adverse events by using the European pharmacovigilance database.
Semaglutide: Thyroid Cancer Signals Stay Low in New European Safety Review
Pharmacol Rep
by Anatriello A, Liguori V, Pentella C et al.
“Evaluation of the safety profile of glucagon-like peptide-1 receptor agonists: a focus on thyroid cancer-related adverse events by using the European pharmacovigilance database. Anatriello A(#)(1)(2), Liguori V(#)(1)(2), Pentella C(1)(2), Zinzi A(3)(4)(5), Longo M(6)(7), Caruso P(8), Maiorino MI(7)(8), Esposito K(7)(8), Capuano A(1)(2). Author information: (1)Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy. (2)Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy. (3)Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy. a.zinzi@unilink.it. (4)Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy. a.zinzi@unilink.it. (5)Department of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy. a.zinzi@unilink.it. (6)Department of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy. (7)Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy. (8)Division of Endocrinology and Metabolic Diseases, University of Campania "Luigi Vanvitelli", Naples, Italy. (#)Contributed equally INTRODUCTION: The therapeutic landscape for the treatment of type 2 diabetes mellitus (T2DM) has greatly evolved with the introduction of glucagon-like peptide-1 receptor agonists (GLP-1 RAs); however, concerns regarding their potential association with thyroid cancer have emerged. The aim of this study is to analyze individual case safety reports (ICSRs) involving GLP-1 RAs, focusing on thyroid cancer-related adverse events (AEs) using the European pharmacovigilance database. METHODS: ICSRs reporting GLP-1 RAs (semaglutide, liraglutide, exenatide, lixisenatide, dulaglutide) or the dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide as suspected drugs were retrieved from the EudraVigilance (EV) database from 1st January 2022 to 26th September 2024. A disproportionality analysis was performed to compare the probability of reporting thyroid cancer-related AEs among these drugs using the reporting odds ratio (ROR) and its 95% confidence interval (95% CI). Considering the different therapeutic indications, a sensitivity analysis was also conducted. RESULTS: A total of 34,956 ICSRs were included in the analysis. The majority of AEs were experienced by adult and elderly female patients. The most reported system organ classes (SOCs) were: "gastrointestinal disorders", "general disorders and administration site conditions", and "injury, poisoning and procedural complications". Disproportionality analysis revealed that semaglutide had a lower probability of reporting thyroid cancer-related AEs than tirzepatide (ROR = 0.54, 95% CI 0.37-0.81, p < 0.05), whereas sensitivity analysis revealed no significant signals across stratified therapeutic groups. CONCLUSION: These findings should be interpreted with caution, given the inherent limitations of pharmacovigilance databases. Further studies are recommended to better assess the potential causal relationship between GLP-1 RAs and thyroid cancer. © 2026. The Author(s). Conflict of interest statement: Declarations. Competing interests: The authors declare no competing interests.”
Semaglutide and tirzepatide, two big names in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) research world, just got a fresh safety check. Researchers dug through nearly 35,000 safety reports from the European EudraVigilance database, zeroing in on thyroid cancer-related events. The goal: see if these research peptides are showing any signals worth flagging.
Here’s what stands out:
Semaglutide had a lower reported rate of thyroid cancer-related adverse events than tirzepatide. The reporting odds ratio (ROR) for semaglutide compared to tirzepatide came in at 0.54. Translation: reports mentioning thyroid cancer were roughly half as likely for semaglutide.
Most reports involved adult and elderly women, but these were swamped by the usual suspects—gastrointestinal complaints, general reactions, and mishaps during administration.
When researchers sliced the data by different therapeutic uses, no clear thyroid cancer signal popped up for any group.
Key takeaway: The numbers don’t point to a spike in thyroid cancer reports for semaglutide or other GLP-1 RAs in routine European safety tracking. The authors keep it real—pharmacovigilance data has limits, and this isn’t a hard proof, just another piece of the puzzle.
For the research community, this is another green light to keep exploring the potential of semaglutide and tirzepatide. If you’re digging into sourcing or protocol design, check out the semaglutide profile or hit the vendor directory for more options.
Bottom line: GLP-1 RA research keeps rolling, and safety signals look steady for now.
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