Risk of Hypersensitivity Reactions to Iopromide in Children and Elderly

Abstract

The aim of this study was to analyze the risk of hypersensitivity reactions (HSRs) to iopromide in children and elderly patients in comparison to adults. Materials and Methods: Four observational studies were pooled and analyzed (analysis I). In addition, spontaneous reports from 1985 to 2020 from the pharmacovigilance database were evaluated (analysis II). All patients received iopromide for angiographic procedures or contrast-enhanced computed tomography in various indications. In analysis I, a nested case-control analysis, including a multivariable logistic regression model, based on pooled observational study data, was performed. Cases were defined as patients with a typical and unequivocal HSR; controls were patients without any recorded reaction. In analysis II, all spontaneous reports on HSRs after iopromide administration recorded in the pharmacovigilance database were descriptively analyzed. Exposure estimates on the size of the exposed age groups were derived from sales data and data from market research. The primary target variable was the risk of HSR to iopromide in children (<18 years) and elderly patients (≥65 years) compared with adults (≥18 to <65 years). Results: In analysis I, a total of 132,850 patients were included (2978 children, 43,209 elderly, and 86,663 adults). Hypersensitivity reactions were significantly less frequent in children (0.47%) and elderly (0.38%) compared with adults (0.74%). The adjusted odds ratio (vs adults) for children was 0.58 (95% confidence interval, 0.34-0.98; P < 0.043), and that for the elderly was 0.51 (95% confidence interval, 0.43-0.61; P < 0.001), indicating a lower risk for both subpopulations as compared with adults. In analysis II, of the overall >288 million iopromide administrations, 5.87, 114.18, and 167.97 million administrations were administered to children, elderly, and adults, respectively. The reporting rate for HSRs in children (0.0114%) and elderly (0.0071%) was significantly lower as compared with adults (0.0143%) ( P < 0.0001). Conclusions: Hypersensitivity reactions to iopromide were significantly less frequent in children and elderly compared with adults.

CT-based radiomics combined with hematologic parameters for survival prediction in locally advanced esophageal cancer patients receiving definitive chemoradiotherapy

“…The scanning parameters of CT were as follows: section thickness 5.0 mm, tube voltage 120 kV, tube current 220 mA. Iopromide injection [ 21 ] (300 mg/mL) was rapidly injected through the patient’s elbow vein with a high-pressure syringe at a flow rate of 2 mL/s at a dose of 1.5 mL/kg body weight.…”

Safety asssessment of iopromide contrast media: a narrative review focusing on adverse events

“…In all studies, the population was considered homogenous concerning gender, which bespeaks the important role of these compounds in medical practice for all patients. However, two recent studies performed by Endrikat et al demonstrated a higher risk of iopromide hypersensitivity reactions in adults, particularly when administered via the intravenous route, when compared with children and older individuals [31]. Still, other studies have reported conflicting results regarding the relationship between age and ARs [27,28].…”

“…The safety profile of iopromide has been characterised through extensive studies reporting the ARs, possibly by applying it to the databases records. Regardless the vast clinical experience with contrast media, including iopromide, many safety issues still need elucidation [31]. Despite being described as safe with rare serious ARs, ICM use can be potentially severe and even lethal [25,32,33].…”

“…Some findings indicate that iopromide-associated hypersensitivity reactions were higher in adults compared to children and the elderly [31] and correlates the IV route to increase incidence of ARs [10,32]. However, other studies reported conflicting findings, with higher risks of ARs observed in elderly patients [25] or no clear relationship between age and the occurrence of ARs [33].…”

Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature

“…However, the incidence of ADRs in elderly patients is not always higher than that in non-elderly adults. Endrikat et al 120 found that the risk of hypersensitivity reactions in patients older than 65 years after iopromide administration was lower than that in non-elderly adults as identified by analysis of the data in four observational studies and the PV database. Gouverneur et al 121 found no more or more severe ADRs with the use of drugs targeting metastatic colorectal cancer (mCRC) in elderly patients in their analysis of ICSRs in VigiBase.…”