High-risks drug adverse events associated with Cetirizine and Loratadine for the treatment of allergic diseases: A retrospective pharmacovigilance study based on the FDA adverse event reporting system database

IF 4.6 2区医学 Q2 ALLERGY Clinical and Translational Allergy Pub Date : 2024-09-10 DOI:10.1002/clt2.12392

Weili Kong, Yijun Dong, Sixi Yi, Wei Mo, Hui Yang

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Abstract

Background

Cetirizine and Loratadine are the two best-selling second-generation antihistamines for allergic diseases. This study aims to provide a comparative analysis of the differences in adverse drug events (ADEs) between these two medications, which can assist clinicians in making appropriate treatment decisions.

Methods

ADE reports related to Cetirizine and Loratadine obtained from the FDA adverse event reporting system (FAERS) database were analyzed using disproportionality analysis and Bayesian analysis to evaluate and compare the ADE signals of both drugs.

Results

A total of 28,051 and 28,073 ADE reports were retrieved from the FAERS database related to Cetirizine and Loratadine, respectively, with both drugs showing a predominance of middle-aged females. Specifically, Loratadine was associated with respiratory symptoms, mainly nasal symptoms such as rhinorrhea (n = 326, ROR 6.75), sneezing (n = 251, ROR 15.24), and nasal congestion (n = 185, ROR 4.25), while Cetirizine did not show this association. Notably, both drugs exhibited strong signals for somnolence in the nervous and psychiatric systems, especially Cetirizine (Cetirizine, n = 2556, ROR 10.52 vs. Loratadine, n = 1200, ROR 7.76). Additionally, Cetirizine itself showed strong signals for attention disturbance (n = 233, ROR 3.3), while Loratadine was associated with nervousness (n = 145, ROR 3.3). Further exploration revealed more severe adverse reactions closely associated with Cetirizine, including hallucinations, aggression, and abnormal behavior. Importantly, Cetirizine was significantly associated with the occurrence of pericarditis (n = 138, ROR 8.13), potentially leading to serious adverse consequences.

Conclusion

Compared to Loratadine, Cetirizine poses a greater potential risk in the nervous and psychiatric systems. Additionally, this study reveals previously underestimated potential cardiac toxicity of Cetirizine; albeit at a relatively low incidence rate, the high signal intensity warrants further attention and exploration. These findings highlight the need for enhanced patient monitoring and therapy optimization when prescribing these medications, ensuring better management of allergic diseases while minimizing risks.

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与治疗过敏性疾病的西替利嗪和氯雷他定相关的高风险药物不良事件：基于美国食品药物管理局不良事件报告系统数据库的回顾性药物警戒研究

背景西替利嗪和氯雷他定是治疗过敏性疾病的两种最畅销的第二代抗组胺药。本研究旨在对这两种药物的不良反应（ADEs）差异进行比较分析，从而帮助临床医生做出适当的治疗决定。方法采用不成比例分析法和贝叶斯分析法对从 FDA 不良事件报告系统（FAERS）数据库中获得的西替利嗪和氯雷他定的相关 ADE 报告进行分析，以评估和比较这两种药物的 ADE 信号。结果从 FAERS 数据库中分别检索到 28,051 份和 28,073 份与西替利嗪和氯雷他定有关的 ADE 报告，两种药物均以中年女性为主。具体而言，氯雷他定与呼吸道症状有关，主要是鼻部症状，如鼻出血（n = 326，ROR 6.75）、打喷嚏（n = 251，ROR 15.24）和鼻塞（n = 185，ROR 4.25），而西替利嗪则没有这种关联。值得注意的是，这两种药物在神经和精神系统中都显示出强烈的嗜睡信号，尤其是西替利嗪（西替利嗪，n = 2556，ROR 10.52 vs. 氯雷他定，n = 1200，ROR 7.76）。此外，西替利嗪本身显示出强烈的注意力障碍信号（n = 233，ROR 3.3），而氯雷他定则与神经紧张有关（n = 145，ROR 3.3）。进一步研究发现，更严重的不良反应与西替利嗪密切相关，包括幻觉、攻击性和行为异常。重要的是，西替利嗪与心包炎的发生显著相关（n = 138，ROR 8.13），可能导致严重的不良后果。结论与氯雷他定相比，西替利嗪对神经和精神系统的潜在风险更大。此外，本研究还揭示了西替利嗪以前被低估的潜在心脏毒性；尽管发生率相对较低，但高信号强度值得进一步关注和探讨。这些发现凸显了在处方这类药物时加强患者监测和优化治疗的必要性，从而确保更好地管理过敏性疾病，同时最大限度地降低风险。

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来源期刊

Clinical and Translational Allergy Immunology and Microbiology-Immunology

CiteScore

7.50

自引率

4.50%

发文量

117

审稿时长

12 weeks

期刊介绍： Clinical and Translational Allergy, one of several journals in the portfolio of the European Academy of Allergy and Clinical Immunology, provides a platform for the dissemination of allergy research and reviews, as well as EAACI position papers, task force reports and guidelines, amongst an international scientific audience. Clinical and Translational Allergy accepts clinical and translational research in the following areas and other related topics: asthma, rhinitis, rhinosinusitis, drug hypersensitivity, allergic conjunctivitis, allergic skin diseases, atopic eczema, urticaria, angioedema, venom hypersensitivity, anaphylaxis, food allergy, immunotherapy, immune modulators and biologics, animal models of allergic disease, immune mechanisms, or any other topic related to allergic disease.