Iopromide safety assessment in a radiology department: A seven-year retrospective characterization of adverse events

Abstract

BACKGROUND: Since the mid-20th century, contrast agents have been widely used in radiology due to their ability to provide high-definition radiographic images and greater precision in diagnostic exams. Different types of contrast agents are used in image diagnosis, namely radiological media. Despite being considered safe, there are still uncertainties about their safety profile, interactions, and incidence of adverse drug reactions in real-world settings. OBJECTIVE: To characterise the pattern of adverse events, during 7 years, in a radiology unit. METHODS: We performed a retrospective observational and descriptive study at an Image Center in Portugal between August 2012 and October 2019. A total of 77,449 computed tomography (CT) were registered, and from those 15,640 cases of iopromide were used as a contrast agent. The authors have accessed, under the authorization, the data of adverse events and procedures after the event. RESULTS: Most of the hypersensitivity events were immediate or with a short time of onset, with the majority of cases developing events with skin involvement and mild degree, where the most common events were papules (n = 60), pruritus (n = 42), erythema (n = 27) and urticaria (n = 14). Severe events, including hypersensitivity, were mainly represented by vomiting (n = 11), stridor (n = 8), breathing difficulties (n = 7) and syncope (n = 3). Abdominal-pelvic CT exam presented a higher frequency of adverse events. CONCLUSION: Despite all the current information about iopromide usage, the utilization of this agent is not abstent of risks and its safety profile not fully established. Most frequent symptoms were local, as skin adverse events, including papules, pruritus and erythema. Common medications used to treat or control adverse events were frequently hydrocortisone, clemastine and methylprednisolone.