Acute adverse reactions to iopromide vs iomeprol: A retrospective analysis of spontaneous reporting from a radiology department

摘要

Objective: To compare the safety of iopromide and iomeprol use in a hospital that switched fromthe former to the latter and found an apparent increase in the number (and a different profile) of adverse reactions reported for iomeprol, putting the safety of its use into question. Methods: This was a retrospective study of cases of acute reactions to iopromide and iomeprol reported in two successive time periods. Data from examinations using iopromide (62 539 CT scans and 10 348 urography scans) and iomeprol (34308 CT scans and 2846 urography scans) were obtained from the computer system of the hospital. Results: For each period, 154 cases of reactions were reported for iopromide and 86 for iomeprol, being severe in 10 (6.5%) patients for iopromide vs 17 (19.8%) patients for iomeprol; a statistically significant difference of <,0.003 was recorded. The most frequent adverse reactions (%/%) for iopromide/iomeprol were urticaria (29.1/17.2), pruritus (22.6/15.6), upper respiratory tract signs and symptoms (12.1/16.7), oedema (4.3/0), erythemas (3.4/5.0), nausea or vomiting (1.2/11.7) and chest pain (0/3.9) (<,0.0001 for the global comparison). The distribution of the reactions (%/%) by System Organ Class for iopromide/iomeprol was skin (56.7/41.1), respiratory (19.2/26.7), vascular (6.8/2.2), general (5.3/7.2), gastrointestinal (4.6/15.0) and others (7.4/7.9) (<,0.0002 for the global comparison). Conclusion: Adverse reactions were more severe for iomeprol. Skin and vascular reactions with no chest pain were more frequent for iopromide, whereas gastrointestinal reactions were more frequent for iomeprol. Advances in knowledge: Comparative studies of media contrast safety are scarce and summary information on product characteristics is insufficient. This study showed the differences in severity and profile of adverse reactions between iopromide and iomeprol.