Sodium zirconium cyclosilicate-associated adverse events: An analysis of the FAERS database.

Abstract

Purpose: This study aims to investigate the adverse drug event (ADE) signals associated with potassium ion binding agent sodium zirconium cyclosilicate (SZC)using the United States Food and Drug Administration's adverse event reporting system (FAERS), providing insights for its safe clinical application.

Materials and methods: Adverse reactions related to SZC were retrieved from the FAERS database, covering the period from May 2018 to September 2023. The analysis utilized several statistical methods, including the reporting odds ratio (ROR), medicines and healthcare regulatory agency (MHRA), Bayesian confidence propagation neural network (BCPNN), and the Multi-item Gamma Poisson Shrinker (MGPS) method under the proportioanl imbalance approach.

Results: A total of 35 positive ADE signals were identified from 1,069 ADE reports where SZC was the primary suspect. These signals encompassed 10 different system organ classes (SOCs).

Conclusion: This study successfully identified and analyzed ADE signals from the FAERS database, contributing valuable insights for evaluating the rationality and safety of clinical medication practices involving SZC.