Assessing the real-world drug safety of sevelamer for hyperphosphatemia: Insights from a comprehensive analysis of the FDA adverse event reporting system (FAERS) database

Abstract

This study aims to assess the adverse events related to sevelamer using real-world data, offering valuable insights for its appropriate clinical use. Data was extracted from the FDA Adverse Event Reporting System database, and disproportionality analysis methods were applied to evaluate the safety of sevelamer. Additionally, the Weibull distribution model was used to examine the temporal relationship between adverse events and treatment duration. The analysis confirmed known adverse reactions such as gastrointestinal ulcers, colitis, and abnormalities in blood calcium levels, while also identifying new potential reactions, including intestinal crystal deposits, decreased transferrin saturation, pseudopolyp, pneumatosis, abdominal pain, skin fibrosis, and acute lung injury. The findings emphasize the need for close monitoring and prevention of adverse reactions, particularly within the first year of treatment. By verifying known reactions and uncovering new ones, this study provides essential safety information for the clinical use of sevelamer, aiding informed decision-making and facilitating the management of associated adverse events.

Keywords: FAERS; disproportionality analysis; hyperphosphatemia; sevelamer; the Weibull distribution.