Abstract
INTRODUCTION: Cefuroxime allergy may present as a delayed-type reaction or as an immunoglobulin (Ig)E-mediated immediate-type anaphylactic reaction. The basophil activation test (BAT) is a diagnostic tool for cefuroxime-induced immediate-type reactions, whereas the lymphocyte transformation test (LTT) is typically applied in delayed-type drug allergy. This study aimed to compare the results of the BAT and LTT in 15 patients with cefuroxime-induced anaphylactic reactions considered as confirmed. The pharmacoepidemiological part aimed to analyze spontaneous reports of cefuroxime-associated anaphylactic reactions in the European adverse drug reaction database (EudraVigilance). METHODS: In EudraVigilance, 668 reports of cefuroxime-associated anaphylactic reactions for the European Economic Area (EEA) between 2010 and 2023 were analyzed, with 182 (27.2%) of these reports originating from Germany. The BAT and the LTT were performed according to standard protocols. Except for one patient, all BAT were performed prior to the skin tests, whereas all LTT were performed thereafter. RESULTS: Almost all reports were classified as serious (EEA, 99.3%; Germany, 98.9%). In 60.8% (EEA) and 66.9% (Germany) of reports with respective information, the reaction occurred after intravenous administration. BAT was performed in 12 of 15 patients (3/12 positive; sensitivity 25%), while LTT was performed in all 15 patients (7/15 positive; sensitivity 46.7%). CONCLUSIONS: Our analysis highlights the importance of cefuroxime-associated anaphylactic reactions, as almost all of the spontaneous reports were classified as serious. Neither a negative BAT nor LTT can rule out a sensitization in cefuroxime-induced anaphylactic reactions.