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.

Keywords: Diabetes mellitus; Pharmacovigilance; Semaglutide.

Figure 1

The flow diagram of selecting semaglutide‐related adverse events from the FAERS database.

Figure 2

The number of reported adverse events and gender differences in semaglutide during 2018 Q1–2023 Q2.

Figure 3

The bar plot shows a statistical graph of the 21 SOCs associated with case reports of semaglutide adverse events. Percentage values labeled in the figure represent the proportion of cases in which semaglutide had an adverse event in each SOC. The different colors represent the signal strength (IC025), the redder the color, the higher the signal strength.

Figure 4

The radial plot shows 36 common and new preferred terms in the top 6 signal strength of SOCs of semaglutide ranked by IC025. Different colors represent different SOCs. The number marked in the graph represents the signal strength (IC025), and the higher the number, the higher the signal strength.