A 13-years pharmacovigilance analysis of novel hormonal agents in prostate cancer using the FDA adverse event reporting system database

BackgroundNovel hormonal agents (NHAs), such as abiraterone, apalutamide, enzalutamide, and darolutamide, play a pivotal role in prostate cancer treatment. However, the toxicity spectrum of NHAs in the real-world has not been fully investigated. This study aims to analyze the adverse events (AEs) linked to NHAs.MethodsThe safety profiles of NHAs were evaluated by using the United States FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis methods were applied to compare the safety signals of AEs associated with NHAs.ResultsOur research has identified significant safety signals for all NHAs in vascular disorders, particularly noting elevated risk in the combined treatment involving docetaxel or poly ADP-ribose polymerase (PARP) inhibitors, specifically in blood and lymphatic system. Apalutamide, enzalutamide, and darolutamide displayed notable safety signals related to nervous system disorders, whereas abiraterone did not. Apalutamide exhibited specific AEs primarily linked to skin and subcutaneous tissue disorders, with severe AEs (SAEs) also concentrated in this category. Enzalutamide's specific AEs were predominantly associated with gastrointestinal disorders. Meanwhile, abiraterone's SAEs were mainly related to cardiac and hepatobiliary disorders.ConclusionOur study offers a comprehensive overview of safety signals associated with NHAs, providing a valuable reference for drug selection and future prospective research.