Expert opinion on drug safety · 2024
Hematological adverse events associated with anti-MRSA agents: a real-world analysis based on FAERS.
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Yu Xiuheng, Zhou Xiaodan, Li Min, Zhao Yu
Аннотация
This study investigated the patterns of hematological adverse events related to daptomycin (DAP), tigecycline (TIG), vancomycin (VAN) and linezolid (LIN) in the FDA Adverse Event Reporting System (FAERS). Adverse event associations were analyzed through calculating reporting odds ratio (ROR), proportional reporting ratio (PRR), multiple gamma Poisson shrinkage (MGPS), and Bayesian confidence propagation neural network (BCPNN). A comprehensive descriptive analysis was also conducted considering factors such as age, gender, daily dose, cumulative dose, and time to onset. The leading hematologic adverse events were eosinophilia for daptomycin, coagulation abnormalities and thrombocytopenia for tigecycline, thrombocytopenia, neutropenia, and anemia for linezolid, and thrombocytopenia, eosinophilia, and neutropenia for vancomycin. Most of the affected patients were over 55 years old. Daily doses for the tigecycline and daptomycin groups exceeded the standard daily dose. The times to onset were 14.00 days for daptomycin (interquartile range [IQR], 4.00-21.00), 6.00 days for tigecycline (IQR, 2.00-9.00), 10.00 days for linezolid (IQR, 4.00-16.5), and 10.00 days for vancomycin (IQR,5.00-20.00). It is essential to intensify early monitoring and identification of these adverse events, especially in the context of off-label dosages and for elderly patients and individuals taking medication for over one week.
Предметные рубрики MeSH
HumansMiddle AgedMaleFemaleAnti-Bacterial AgentsAdverse Drug Reaction Reporting SystemsAgedLinezolidAdultTigecyclineMethicillin-Resistant Staphylococcus aureusHematologic DiseasesVancomycinUnited StatesDaptomycinDose-Response Relationship, DrugStaphylococcal InfectionsUnited States Food and Drug AdministrationBayes TheoremYoung AdultTime Factors