Objective: We evaluated the safety of the universal use of the nonionic iodinated contrast agent iopromide in patients undergoing CT in a large urban teaching hospital.
Subjects and methods: For 2 years, we prospectively recorded all adverse events temporally associated with the administration of iopromide in 29,508 consecutive patients undergoing contrast-enhanced CT at our institution. The types, intensities, treatments, and outcomes of adverse events were recorded along with relevant patient history, including risk factors. Descriptive analyses of the variables, comparisons of means, and proportions using Student's t and chi-square tests, and logistic regressions were conducted.
Results: Adverse events were observed in 211 patients (0.7%) and were categorized as follows: urticaria (n = 161), facial or laryngeal edema (n = 13), bronchospasm (n = 8), severe nausea or vomiting (n = 10), or other (n = 19). One hundred eighty-eight adverse events (89%) were rated mild, 19 moderate (9%), and four severe (2%), including one fatality. Adverse events required treatment in 89 patients (42%). A history of allergy was present in 92 patients (44%), and 29 (14%) had a prior contrast reaction. Other relevant risk factors were identified in 63 patients (30%). No relationship existed between the occurrence of adverse events and any of the following: patient age, dose of iodine administered, or time of study (i.e., month, season, and year). Women (p < 0.001) and outpatients (p < 0.001) had a statistically significant higher incidence of adverse events.
Conclusion: The universal use of iopromide as an IV CT contrast agent has a favorable safety profile.