European journal of clinical pharmacology · 2025
Severe drug-associated anaphylaxis: a complementary descriptive analyses of registry cases and spontaneous reports.
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Christ Patrick, Dubrall Diana, Dölle-Bierke Sabine, Francuzik Wojciech, Schmid Matthias, Sachs Bernhardt, Worm Margitta
Аннотация
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.
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.