A pharmacovigilance study of etoposide in the FDA adverse event reporting system (FAERS) database, what does the real world say?

作者：Zhiwei Cui, Feiyan Cheng, Lihui Wang, Fan Zou, Rumeng Pan, Yuhan Tian, Xiyuan Zhang, Jing She, Yidan Zhang, Xinyuan Yang · 发表于：Frontiers in Pharmacology · 年份：2023 · DOI：10.3389/fphar.2023.1259908 · 被引用次数：55 · 研究领域：Pharmacovigilance and Adverse Drug Reactions、Drug-Induced Adverse Reactions、Pharmacological Effects and Toxicity Studies

Introduction: Etoposide is a broad-spectrum antitumor drug that has been extensively studied in clinical trials. However, limited information is available regarding its real-world adverse reactions. Therefore, this study aimed to assess and evaluate etoposide-related adverse events in a real-world setting by using data mining method on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods: Through the analysis of 16,134,686 reports in the FAERS database, a total of 9,892 reports of etoposide-related adverse drug events (ADEs) were identified. To determine the significance of these ADEs, various disproportionality analysis algorithms were applied, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms. Results: As a result, 478 significant disproportionality preferred terms (PTs) that were identified by all four algorithms were retained. These PTs included commonly reported adverse events such as thrombocytopenia, leukopenia, anemia, stomatitis, and pneumonitis, which align with those documented in the drug’s instructions and previous clinical trials. However, our analysis also uncovered unexpected and significant ADEs, including thrombotic microangiopathy, ototoxicity, second primary malignancy, nephropathy toxic, and ovarian failure. Furthermore, we examined the time-to-onset (TTO) of these...