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

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Publication Details

Journal
PLoS ONE
Published
2026-09-17
DOI
https://doi.org/10.1371/journal.pone.0356800
Primary Topic
Cancer Treatment and Pharmacology
Type
article
Field-Weighted Citation Impact
0.00
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article

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

Anqi Ge, Jie Gong, Shiting Wu, Ruhong Zhou et al.
PLoS ONE
Cancer Treatment and Pharmacology
article

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

Anqi Ge, Jie Gong, Shiting Wu, Ruhong Zhou, Lele Shen, Lin Qi, Jie Ling, Lifang Liu
article en

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.

PLoS ONEVol. 21(9)
First Affiliated Hospital of Hunan University of Traditional Chinese Medicine (CN), Hunan Academy of Traditional Chinese Medicine (CN), Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine (CN)
Good health and well-being
Openalex Percentile: Top 14%
Cancer Treatment and Pharmacology
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