Identifying new safety risk of human serum albumin: a retrospective study of real-world data.

ABSTRACT: Objective: To mine and analyze the adverse reaction signals of human serum albumin (HSA) using the FDA adverse event reporting system (FAERS) database for the safe clinical use of this drug. Methods: Data cleaning and analysis of adverse event reports in the FAERS database for a total of 76 quarters from Q1 2004 to Q4 2022 were performed using the reporting odds ratio (ROR), Medicines and Healthcare Products Regulatory Agency (MHRA), and Bayesian confidence propagation neural network (BCPNN). Gender-differentiated signal detection was used to investigate the gender differences in the occurrence of HSA adverse events. Results: Through a combination of three methods, a total of 535 adverse event reports were identified. These reports involved 1,885 cases of adverse react

SUBMITTER: Lu H 

PROVIDER: S-EPMC10825956 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature