Safety and adverse effects during 24 hours after contrast-enhanced MRI with gadobenate dimeglumine (MultiHance®) in children

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Abstract
Background Gadolinium-based MR contrast agents have long been considered safe for routine diagnostic imaging. However, the advent of nephrogenic systemic fibrosis (NSF) among certain patients with severe renal insufficiency has brought the issue of safety into question. Nowhere is safety of greater concern than among children who frequently require multiple contrast-enhanced MRI examinations over an extended period of time. Objective To retrospectively evaluate the safety of gadobenate dimeglumine for contrast-enhanced (CE) MRI across a range of indications. Materials and methods Two hundred pediatric inpatients (age: 4 days to 15 years) underwent CE MRI as part of clinical routine. The children received a gadobenate dimeglumine dose of either 0.05 mmol/kg body weight (liver, abdominal imaging, musculoskeletal imaging, brain and other rare indications) or 0.1 mmol/kg bodyweight (cardiovascular imaging, MR-urography). Young (< 8 years) children with congenital heart disease were intubated and underwent MRA evaluation with controlled ventilation. Monitoring for adverse events was performed for at least 24 h after each gadobenate dimeglumine injection. Depending on clinical necessity, laboratory measurements and, in some cases, vital sign and ECG determinations were made before and after contrast injection. Safety was evaluated by age group, indication and dose administered. Results No clinically adverse events were reported among children who had one MRI scan only or among children who had several examinations. There were no changes in creatinine or bilirubin levels even in very young children. Conclusions No adverse events were recorded during the first 24 h following administration of gadobenate dimeglumine in 200 children.

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