A real-world disproportionality analysis of semaglutide: Post-marketing pharmacovigilance data

Abstract

Aim/Introduction: The recent adverse reactions associated with semaglutide have led the Food and Drug Administration (FDA) to issue a “black box warning”, and it is necessary to analyze all reports of adverse reactions to improve the safety of its clinical use. Materials and Methods: Statistical analyses and signal mining were performed by obtaining the adverse event reports related to semaglutide in the FAERS database from the first quarter of 2018 to the fourth quarter of 2023. We used disproportionality and Bayesian analysis to examine clinical and demographic attributes, trends reported quarterly, and contrasts between two distinct indications (obesity and type 2 diabetes). Results: We found 10 unexpected adverse signals related to “pancreatic cancer”, “intestinal obstruction”, “cholecystitis”, and “polycystic ovary” and both the two different indications had the same serious adverse reaction events occurring. Conclusions: This study identified many unexpected signals of serious adverse reactions, suggesting the importance of continuous post-marketing surveillance of semaglutide to understand its potential risks.