Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, University of Illinois Chicago, Chicago, Illinois, USA.
College of Pharmacy, University of Illinois Chicago, Chicago, Illinois, USA.
Pharmacotherapy. 2024 May;44(5):383-393. doi: 10.1002/phar.2920. Epub 2024 Apr 24.
To determine whether there is a signal for gastrointestinal (GI) or intracranial (IC) hemorrhage associated with the use of antiviral medications for influenza in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.
Disproportionality analysis.
The FAERS database was searched using OpenVigil 2.1 to identify GI and IC hemorrhage events reported between 2004 and 2022.
Antiviral medications for influenza included the following: oseltamivir, zanamivir, peramivir, and baloxavir marboxil. Hemorrhage events were identified using Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries for GI and IC hemorrhages. Reporting odds ratios (RORs) were calculated to compare the occurrence of GI and IC hemorrhage events between antiviral drugs for influenza and (i) all other medications and (ii) antibiotics. RORs were also calculated for each of the individual antiviral medications.
A total of 245 cases of GI hemorrhage and 23 cases of IC hemorrhage were identified in association with four antivirals. In comparison with all other drugs, the RORs of GI hemorrhage for oseltamivir, zanamivir, peramivir, baloxavir, and all antivirals combined were 1.17, 0.62, 4.44, 2.53, and 1.22, respectively, indicating potential variations in GI hemorrhage risk among the antivirals. In contrast, in comparison with all other drugs, the RORs of IC hemorrhage for oseltamivir (0.44), zanamivir (0.16), baloxavir (0.44), and all antivirals combined (0.41) were less than 1.0 which is consistent with no elevated risk of IC hemorrhage.
In this study, some signals for GI hemorrhage were observed, particularly for peramivir and baloxavir marboxil. Further investigation is warranted to better understand and evaluate the potential risks of GI hemorrhage associated with antiviral treatments for influenza.
在美 FDA 不良事件报告系统（FAERS）数据库中，确定使用抗病毒药物治疗流感与胃肠道（GI）或颅内（IC）出血之间是否存在信号。
不稳定性分析。
使用 OpenVigil 2.1 搜索 FAERS 数据库，以识别 2004 年至 2022 年期间报告的 GI 和 IC 出血事件。
流感抗病毒药物包括奥司他韦、扎那米韦、帕拉米韦和巴洛沙韦马博瑞尔。使用 GI 和 IC 出血的 MedDRA 标准化医学词典查询（MedDRA）来识别出血事件。计算报告比值比（ROR）以比较流感抗病毒药物与（i）所有其他药物和（ii）抗生素之间 GI 和 IC 出血事件的发生情况。还计算了每种抗病毒药物的 ROR。
在与四种抗病毒药物相关的研究中，共发现 245 例 GI 出血和 23 例 IC 出血病例。与所有其他药物相比，奥司他韦、扎那米韦、帕拉米韦、巴洛沙韦和所有抗病毒药物组合的 GI 出血 ROR 分别为 1.17、0.62、4.44、2.53 和 1.22，表明抗病毒药物之间的 GI 出血风险存在潜在差异。相比之下，与所有其他药物相比，奥司他韦（0.44）、扎那米韦（0.16）、巴洛沙韦（0.44）和所有抗病毒药物组合（0.41）的 IC 出血 ROR 小于 1.0，这与 IC 出血风险无升高一致。
在这项研究中，观察到了一些 GI 出血的信号，特别是对于帕拉米韦和巴洛沙韦马博瑞尔。需要进一步调查以更好地了解和评估与流感抗病毒治疗相关的 GI 出血的潜在风险。
