Identification of the Top 15 Drugs Associated With Anaphylaxis: A Pharmacovigilance Study

IF 5.2 2区医学 Q1 ALLERGY

Clinical and Experimental Allergy Pub Date : 2025-06-08 DOI:10.1111/cea.70092

Tae Hyeon Kim, Jaeyu Park, Hyesu Jo, Jeongseon Oh, Kyeongmin Lee, Jiyeon Oh, Hayeon Lee, Lee Smith, Guillermo F. López Sánchez, Yerin Hwang, Dong Keon Yon

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Abstract

Background

Drug-associated anaphylaxis is a common condition with significant risks if not promptly addressed. Yet, systematic research on the distribution of associated drugs and risk comparison across drug classes is limited. This study aims to identify frequently reported drugs and evaluate the strength of their signal detections with drug-associated anaphylaxis.

Methods

This study employed a global pharmacovigilance database to identify reports of drug-associated anaphylaxis. Reports classified as anaphylaxis were analysed using the drug record number used in global pharmacovigilance database, leading to the identification of 15 frequently associated drugs. A disproportionality analysis was conducted to estimate signal detections between these selected drugs and anaphylaxis, utilising two metrics: the information component (IC) with a threshold of IC_0.25 and the reporting odds ratio (ROR) with 95% confidence intervals (CI). To account for the acute onset of anaphylaxis, a sensitivity analysis focused on reports with a time to onset of less than a day.

Results

We identified 15 drugs frequently associated with anaphylaxis, with diclofenac recording the highest number of reports at 34,413. The drug indicating the strongest signal detection with anaphylaxis was cefuroxime (ROR, 40.89 [95% CI, 40.18–41.61]; IC, 5.14 [IC_0.25, 5.11]), followed by levofloxacin, ibuprofen, COVID-19 vaccine, ceftriaxone, lidocaine, omalizumab, cefuroxime, benzylpenicillin, clindamycin, amoxicillin/clavulanate, cefazolin, ciprofloxacin, metronidazole, and paclitaxel. Sensitivity analysis indicated that the signal detection between the COVID-19 vaccine and anaphylaxis was stronger than in the primary analysis (ROR, 2.49 [95% CI, 2.45–2.53]; IC, 1.23 [IC_0.25, 1.21]). While most drugs reported that the majority of drug-associated anaphylaxis reports occurred within 2.5 h, omalizumab was often associated with reactions occurring after 24 h.

Conclusion

All drugs frequently reported in association with anaphylaxis indicated a significant signal detection, but the strength of these signal detections did not align with the number of reports. Time-to-onset analysis showed distinct patterns for certain drugs, suggesting different mechanisms of anaphylaxis. Due to the limitations of spontaneous reporting databases with disproportionality analysis, our findings do not permit for causal inference.

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鉴别与过敏反应相关的前15种药物：一项药物警戒研究。

背景：药物相关性过敏反应是一种常见的疾病，如果不及时处理，风险很大。然而，对相关药物分布和跨药物类别风险比较的系统研究是有限的。本研究旨在确定频繁报道的药物，并评估其信号检测与药物相关过敏反应的强度。方法：本研究采用全球药物警戒数据库来识别药物相关过敏反应的报告。使用全球药物警戒数据库中使用的药物记录号对归类为过敏反应的报告进行了分析，从而确定了15种经常相关的药物。使用两个指标：阈值为IC0.25的信息成分（IC）和95%置信区间（CI）的报告优势比（ROR），进行了歧化分析，以估计这些选定药物和过敏反应之间的信号检测。为了解释过敏反应的急性发作，敏感性分析集中在发病时间少于一天的报告上。结果：我们确定了15种经常与过敏反应相关的药物，其中双氯芬酸的报告数量最多，为34,413例。过敏反应信号检测最强的药物是头孢呋辛(ROR, 40.89 [95% CI, 40.18-41.61]；IC, 5.14 [IC0.25, 5.11])，其次是左氧氟沙星、布洛芬、新冠肺炎疫苗、头孢曲松、利多卡因、奥玛单抗、头孢呋辛、青霉素、克林霉素、阿莫西林/克拉维酸、头孢唑林、环丙沙星、甲硝唑、紫杉醇。敏感性分析显示，COVID-19疫苗与过敏反应之间的信号检测强于初步分析(ROR, 2.49 [95% CI, 2.45-2.53]；[ic0.25, 1.21])。虽然大多数药物报告的大多数药物相关过敏反应报告发生在2.5小时内，但omalizumab通常与24小时后发生的反应相关。结论：所有经常报道的与过敏反应相关的药物都有明显的信号检测，但这些信号检测的强度与报道的数量不一致。发病时间分析显示某些药物的不同模式，提示不同的过敏反应机制。由于具有歧化分析的自发报告数据库的局限性，我们的研究结果不允许因果推理。

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

Clinical and Experimental Allergy 医学-过敏

CiteScore

10.40

自引率

9.80%

发文量

189

审稿时长

3-8 weeks

期刊介绍： Clinical & Experimental Allergy strikes an excellent balance between clinical and scientific articles and carries regular reviews and editorials written by leading authorities in their field. In response to the increasing number of quality submissions, since 1996 the journals size has increased by over 30%. Clinical & Experimental Allergy is essential reading for allergy practitioners and research scientists with an interest in allergic diseases and mechanisms. Truly international in appeal, Clinical & Experimental Allergy publishes clinical and experimental observations in disease in all fields of medicine in which allergic hypersensitivity plays a part.