Adverse drug events associated with linezolid administration: a real-world pharmacovigilance study from 2004 to 2023 using the FAERS database

作者：Fan Zou, Zhiwei Cui, Siyu Lou, Yingyong Ou, Chengyu Zhu, Chengjie Shu, Junyou Chen, Ruizhen Zhao, Zhu Wu, Li Wang, Zhenyong Chen, Huayu Chen, Yuanbo Lan · 发表于：Frontiers in Pharmacology · 年份：2024 · DOI：10.3389/fphar.2024.1338902 · 被引用次数：103 · 研究领域：Antimicrobial Resistance in Staphylococcus、Pharmacovigilance and Adverse Drug Reactions、Drug-Induced Adverse Reactions

Introduction: Linezolid is an oxazolidinone antibiotic that is active against drug-resistant Gram-positive bacteria and multidrug-resistant Mycobacterium tuberculosis . Real-world studies on the safety of linezolid in large populations are lacking. This study aimed to determine the adverse events associated with linezolid in real-world settings by analyzing data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Methods: We retrospectively extracted reports on adverse drug events (ADEs) from the FAERS database from the first quarter of 2004 to that of 2023. By using disproportionality analysis including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), along with the multi-item gamma Poisson shrinker (MGPS), we evaluated whether there was a significant association between linezolid and ADE. The time to onset of ADE was further analyzed in the general population and within each age, weight, reporting population, and weight subgroups. Results: A total of 11,176 reports of linezolid as the “primary suspected” drug and 263 significant adverse events of linezolid were identified, including some common adverse events such as thrombocytopenia ( n = 1,139, ROR 21.98), anaemia ( n = 704, ROR 7.39), and unexpected signals that were not listed on the drug label such as rhabdomyolysis ( n = 90, ROR 4.33), and electrocardiogram QT prolonged ( n = 73, ROR 4.07). Linezolid-induced adver...