Adverse events associated with azithromycin and clarithromycin in adults aged ≥65: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-10 DOI:10.1080/14740338.2024.2412226
Zhenpo Zhang, Jiaxin He, Yankun Liang, Yuting Wang, Jingping Zheng, Lin Ma, Ling Su
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Abstract

Background: Azithromycin and clarithromycin are commonly used to treat community-acquired pneumonia in adults aged ≥ 65, such as mycoplasma pneumonia. This study aims to evaluate adverse events (AEs) associated with azithromycin and clarithromycin in this age group by analyzing the FDA Adverse Event Reporting System (FAERS), providing insights for clinical use and management of AEs in this population.

Research design and methods: We retrieved reports of AEs related to azithromycin and clarithromycin from the FAERS database. Disproportionality analysis was conducted using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Gamma Poisson Shrinkage (MGPS) to identify AEs associated with azithromycin and clarithromycin in adults aged ≥ 65.

Results: A total of 2,019 adverse event reports were retrieved for azithromycin, and 2,392 for clarithromycin. Off-label use (n = 349) and drug interactions (n = 487) were the most reported AEs in adults aged ≥ 65 for azithromycin and clarithromycin, respectively. Prolonged QT interval showed the strongest signal among AEs for azithromycin in this age group. Drug interaction-related medication errors had the strongest signal for clarithromycin. Seven signals not explicitly included in the azithromycin package insert were identified in adults aged ≥ 65. Fourteen signals not explicitly included in the clarithromycin package insert were identified.

Conclusions: Among adults aged ≥ 65, cardiac-related adverse events are more closely associated with azithromycin than with clarithromycin. Conversely, AEs related to drug interactions and psychiatric symptoms are more associated with clarithromycin. Additionally, clinicians should be vigilant regarding AEs not specified in the package inserts. The findings of this study may help optimize the selection of azithromycin and clarithromycin based on patient circumstances and assist clinicians in focusing on relevant AEs for early intervention.

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与阿奇霉素和克拉霉素有关的≥65 岁成人不良事件:对 FDA 不良事件报告系统 (FAERS) 数据库的比例失调分析。
背景:阿奇霉素和克拉霉素常用于治疗≥65岁成人的社区获得性肺炎,如支原体肺炎。本研究旨在通过分析美国食品药品管理局不良事件报告系统(FAERS),评估阿奇霉素和克拉霉素在这一年龄组中的相关不良事件(AEs),从而为这一人群中AEs的临床使用和管理提供见解:我们从 FAERS 数据库中检索了与阿奇霉素和克拉霉素相关的 AE 报告。使用报告比值比(ROR)、比例报告比(PRR)、贝叶斯置信度传播神经网络(BCPN)和多伽马泊松收缩(MGPS)进行比例失调分析,以确定年龄≥65岁的成年人中与阿奇霉素和克拉霉素相关的AE:阿奇霉素共检索到 2,019 份不良事件报告,克拉霉素共检索到 2,392 份不良事件报告。阿奇霉素和克拉霉素在标签外使用(349例)和药物相互作用(487例)分别是年龄≥65岁的成人中报告最多的不良反应。在这一年龄组中,阿奇霉素的 AEs 中 QT 间期延长的信号最强。克拉霉素的药物相互作用相关用药错误信号最强。在年龄≥65岁的成人中,阿奇霉素包装说明书中未明确包含的信号有7个。发现了 14 个未明确包含在克拉霉素包装说明书中的信号:结论:在年龄≥65岁的成年人中,心脏相关不良事件与阿奇霉素的关系比与克拉霉素的关系更为密切。相反,与药物相互作用和精神症状相关的不良反应与克拉霉素的关系更为密切。此外,临床医生应警惕包装说明书中未明确指出的不良反应。本研究的结果有助于根据患者的具体情况优化阿奇霉素和克拉霉素的选择,并帮助临床医生关注相关的不良反应,以便及早干预。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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