Christ Patrick, Dubrall Diana, Dölle-Bierke Sabine, Francuzik Wojciech, Schmid Matthias, Sachs Bernhardt, Worm Margitta
Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.
Institute for Medical Biometry, Informatics and Epidemiology (IMBIE), University Hospital of Bonn, Bonn, Germany.
Eur J Clin Pharmacol. 2025 Jun 27. doi: 10.1007/s00228-025-03868-w.
Drugs are among the most common triggers of severe anaphylactic reactions in adults. The aim of our study was to identify the most frequently suspected drugs and associated factors of severe drug-associated anaphylactic reactions in two different data sources. Moreover, the impact of the route of administration (oral versus intravenous) was investigated.
Severe drug-associated anaphylactic reactions from Germany were analysed in 1046 cases of the European Anaphylaxis Registry and in 1878 spontaneous reports of the European adverse drug reaction (ADR) database EudraVigilance.
Several analgesics, antibiotics and contrast media were among others reported most frequently in both data sources. In addition, antineoplastic and immunomodulating agents were commonly reported in spontaneous reports. As associated factors, thyroid disorders, asthma and chronic obstructive pulmonary diseases, as well as cardiovascular diseases, were frequently reported in both. Serious reactions such as cardiac arrest were more commonly reported for intravenously administered drugs, while skin reactions were more common for orally administered drugs.
The analyses of two datasets differing regarding their data collection enables to get a more complete picture of severe anaphylactic reactions in real world settings. Our study confirms that patients with thyroid disorders, cardiovascular and respiratory diseases (e.g. asthma) might carry a higher risk to develop severe anaphylactic reaction. The more serious course of anaphylactic reactions related to intravenously compared to orally applied drugs may result from the faster availability of intravenously administered drugs or differences among the patient populations.
药物是成人严重过敏反应最常见的诱因之一。我们研究的目的是在两个不同的数据源中确定最常被怀疑的药物以及严重药物相关过敏反应的相关因素。此外，还研究了给药途径（口服与静脉注射）的影响。
在欧洲过敏反应登记处的1046例病例以及欧洲药物不良反应（ADR）数据库EudraVigilance的1878份自发报告中，分析了来自德国的严重药物相关过敏反应。
在两个数据源中，几种镇痛药、抗生素和造影剂等被报告的频率最高。此外，抗肿瘤药和免疫调节剂在自发报告中也经常被提及。作为相关因素，甲状腺疾病、哮喘和慢性阻塞性肺疾病以及心血管疾病在两者中都经常被报告。静脉给药的药物更常报告心脏骤停等严重反应，而口服给药的药物皮肤反应更常见。
对两个在数据收集方面存在差异的数据集进行分析，能够更全面地了解现实世界中严重过敏反应的情况。我们的研究证实，甲状腺疾病、心血管和呼吸系统疾病（如哮喘）患者发生严重过敏反应的风险可能更高。与口服药物相比，静脉注射药物引起的过敏反应病程更严重，可能是由于静脉注射药物起效更快或患者群体存在差异。
