Antibiotics and Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome: Analysis of Brazilian Pharmacovigilance Registries.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-04-01 DOI:10.1002/pds.70128

Marcelo Bueno de Camargo, Inês Ribeiro-Vaz, Cristiane de Cássia Bergamaschi, Marcus Tolentino Silva

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引用次数: 0

Abstract

Background and purpose: This study investigated the association between the use of antibiotics and the occurrence of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) syndrome, a rare and serious adverse event characterized by eosinophilia and acute skin rash. Without early diagnosis, the syndrome can lead to complications or even death.

Methods: In 2020, the Brazilian National Health Surveillance Agency (Anvisa) made available a system for reporting adverse drug events, called VigiMed. Reports of adverse events registered on this system between December 1, 2018 and December 31, 2022, were analyzed. Reporting odds ratio (ROR), together with the respective 95% confidence intervals (95% CI), was calculated as a measure of the association between antibiotics and DRESS syndrome.

Results: A total of 160,101 reports of adverse drug events were analyzed, with 136 suspected cases of DRESS syndrome. Compared with other drugs, the following frequencies of suspected DRESS syndrome were observed for the use of any antibiotic (ROR: 4.8; 95% CI: 3.3-7.0), meropenem (ROR: 13.0; 95% CI: 8.0-21.0), vancomycin (ROR: 11.5; 95% CI: 7.4-17.6), ampicillin (ROR: 6.8; 95% CI: 2.1-21.8), amoxicillin (ROR: 4.7; 95% CI: 1.5-15.0), cefepime (ROR: 4.3; 95% CI: 1.3-13.6), piperacillin + tazobactam (ROR: 2.5; 95% CI: 1.1-5.8) and ceftriaxone (ROR: 2.4; 95% CI: 1.1-5.1). The ROR for DRESS syndrome and the use of oxacillin was 2.7 with a wide 95% CI (0.7-11.1).

Conclusions: An association was observed between reports of DRESS syndrome and the use of antibiotics, particularly those routinely used in a hospital setting. Although there is a potential risk of underreporting or unattributed causality, the information obtained in this study is valuable for the analysis of rare adverse reactions. Given the seriousness of the findings, further studies should be conducted to obtain more accurate information about this adverse reaction.

查看原文本刊更多论文

抗生素和药物反应与嗜酸性粒细胞增多和全身症状（DRESS）综合征：巴西药物警戒登记的分析

背景与目的：本研究探讨抗生素使用与DRESS（嗜酸性粒细胞及全身症状药物反应）综合征发生的关系，DRESS是一种罕见且严重的不良事件，以嗜酸性粒细胞增多和急性皮疹为特征。如果没有早期诊断，这种综合征可能导致并发症甚至死亡。方法：2020年，巴西国家卫生监督局（Anvisa）提供了一个报告药物不良事件的系统，称为VigiMed。分析2018年12月1日至2022年12月31日期间在该系统上登记的不良事件报告。计算报告优势比（ROR）以及相应的95%置信区间（95% CI），作为抗生素与DRESS综合征之间关联的度量。结果：共分析药物不良事件报告160101例，其中疑似DRESS综合征136例。与其他药物相比，使用任何抗生素观察到可疑DRESS综合征的频率如下(ROR: 4.8；95% CI: 3.3-7.0)，美罗培南(ROR: 13.0；95% CI: 8.0-21.0)，万古霉素(ROR: 11.5；95% CI: 7.4-17.6)，氨苄西林(ROR: 6.8；95% CI: 2.1-21.8)，阿莫西林(ROR: 4.7；95% CI: 1.5-15.0)，头孢吡肟(ROR: 4.3；95% CI: 1.3-13.6)，哌拉西林+他唑巴坦(ROR: 2.5；95% CI: 1.1-5.8)和头孢曲松(ROR: 2.4；95% ci: 1.1-5.1)。DRESS综合征和使用oxacillin的ROR为2.7,95% CI宽（0.7-11.1）。结论：观察到DRESS综合征的报告与抗生素的使用之间存在关联，特别是在医院常规使用的抗生素。尽管存在漏报或未归因的因果关系的潜在风险，但本研究获得的信息对于罕见不良反应的分析是有价值的。鉴于研究结果的严重性，应进行进一步的研究以获得有关该不良反应的更准确信息。

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

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.