Safety of eribulin: A real-world study based on a pharmacovigilance database.

Abstract

Eribulin is used to treat metastatic breast cancer, but its adverse event (AE) profile requires comprehensive analysis using FDA Adverse Event Reporting System (FAERS) data to guide clinical use. We analyzed eribulin-related AE reports in FAERS (Q1 2011 - Q2 2024). Disproportionality analyses (ROR, PRR, MGPS, BCPNN) identified significant AE signals. Our study finalized 3570 AE reports with eribulin as the primary suspect drug from the FAERS database, including 7455 coded AE records. The included patients were predominantly female (90.1%) and aged 35-59 years (42.61%). Eribulin-associated AEs spanned 26 organ systems. Only "Blood and lymphatic system disorders" (n = 1,788) met significance across all four algorithms. At the preferred term level, 95 positive disproportionality signals emerged. Common expected AEs included neutropenia, febrile neutropenia, and leukopenia. Critically, serious unexpected AEs not consistently referenced in drug inserts were identified, such as pleural effusion, respiratory failure, and cardiac failure. Clinical use of eribulin requires great attention to blood and lymphatic adverse events, as well as enhanced monitoring and reporting of adverse events not mentioned in the insert to prevent serious AEs.