Zhou Jie, Ye Junchang, Chen Maohua, Zheng Xinlei
Department of Pharmacy, Zhangzhou Hospital Affiliated to Fujian Medical University, Zhangzhou, People's Republic of China.
Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan Comprehensive Experimental Area, People's Republic of China.
Expert Opin Drug Saf. 2024 Sep 16:1-9. doi: 10.1080/14740338.2024.2393269.
Baloxavir marboxil (hereafter referred to as baloxavir) is the only cap-dependent endonuclease inhiabitor approved for the treatment and prevention of influenza. However, as a new drug marketed in 2018, the long-term safety of baloxavir in large sample population was unclear. This study aims to evaluate baloxavir-associated adverse events (AEs) through data mining of the international pharmacovigilance database of US FDA Adverse Event Reporting System (FAERS).
Disproportionality analysis was conducted to assess the association between baloxavir and its AEs. Data were collected from FAERS from March 2018 to June 2023. After standardizing the data, signal quantification techniques including ROR, PRR, BCPNN and MGPS were used for analysis.
A total of 49 significant baloxavir-related preferred terms (PTs) in 20 system organ classes (SOCs) were identified in our data analysis. Compared to baloxavir's FDA label, some new PTs emerged, with the top 10 being pneumonia, loss of consciousness, rhabdomyolysis, seizure, altered state of consciousness, hepatic function abnormal, delirium, depressed level of consciousness, encephalopathy and cardio-respiratory arrest.
In clinical application of baloxavir, attention should be paid to the new AE signals in addition to the those recorded in the labels, so as to ensure the safety of the patients.
巴洛沙韦酯（以下简称巴洛沙韦）是唯一被批准用于治疗和预防流感的帽依赖性内切酶抑制剂。然而，作为2018年上市的新药，巴洛沙韦在大样本人群中的长期安全性尚不清楚。本研究旨在通过对美国食品药品监督管理局不良事件报告系统（FAERS）的国际药物警戒数据库进行数据挖掘，评估与巴洛沙韦相关的不良事件（AE）。
进行不成比例分析以评估巴洛沙韦与其不良事件之间的关联。数据收集自2018年3月至2023年6月的FAERS。在对数据进行标准化后，使用包括风险比（ROR）、比例报告比值比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多伽马泊松收缩法（MGPS）在内的信号量化技术进行分析。
在我们的数据分析中，共识别出20个系统器官分类（SOC）中的49个与巴洛沙韦相关的显著首选术语（PT）。与巴洛沙韦的FDA标签相比，出现了一些新的PT，前10位是肺炎、意识丧失、横纹肌溶解、癫痫发作、意识状态改变、肝功能异常、谵妄、意识水平降低、脑病和心肺骤停。
在巴洛沙韦的临床应用中，除标签中记录的不良事件外，还应关注新的不良事件信号，以确保患者的安全。
