Severe drug-associated anaphylaxis: a complementary descriptive analyses of registry cases and spontaneous reports
European Journal of Clinical Pharmacology, vol. 81, pp. 1301–1314
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors 7
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Federal Institute for Drugs and Medical Devices · University Hospital Bonn · Institut für Medizinische Biometrie, Informatik und Epidemiologie
Affiliation as printed
Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
Institute for Medical Biometry, Informatics and Epidemiology (IMBIE), University Hospital of Bonn, Bonn, Germany
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Federal Institute for Drugs and Medical Devices · University Hospital Bonn · Institut für Medizinische Biometrie, Informatik und Epidemiologie
Affiliation as printed
Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
Institute for Medical Biometry, Informatics and Epidemiology (IMBIE), University Hospital of Bonn, Bonn, Germany
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Humboldt-Universität zu Berlin · Berlin Institute of Health at Charité - Universitätsmedizin Berlin · Freie Universität Berlin · Charité - Universitätsmedizin Berlin
Affiliation as printed
Division of Allergy and Immunology, Department of Dermatology, Venerology and Allergology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Berlin Institute of Health, Berlin, Germany
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Humboldt-Universität zu Berlin · Berlin Institute of Health at Charité - Universitätsmedizin Berlin · Freie Universität Berlin · Charité - Universitätsmedizin Berlin
Affiliation as printed
Division of Allergy and Immunology, Department of Dermatology, Venerology and Allergology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Berlin Institute of Health, Berlin, Germany
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University Hospital Bonn · Institut für Medizinische Biometrie, Informatik und Epidemiologie
Affiliation as printed
Institute for Medical Biometry, Informatics and Epidemiology (IMBIE), University Hospital of Bonn, Bonn, Germany
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Federal Institute for Drugs and Medical Devices · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department for Dermatology and Allergy, University Hospital RWTH Aachen, Aachen, Germany. Bernhardt.Sachs@bfarm.de
Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany. Bernhardt.Sachs@bfarm.de
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Margitta Worm corresponding
Humboldt-Universität zu Berlin · Berlin Institute of Health at Charité - Universitätsmedizin Berlin · Charité - Universitätsmedizin Berlin
Affiliation as printed
Division of Allergy and Immunology, Department of Dermatology, Venerology and Allergology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Berlin Institute of Health, Berlin, Germany. margitta.worm@charite.de
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