Abstract
BackgroundThe safety of gadolinium-based contrast agents is a hot topic in radiology.PurposeTo evaluate the safety profile of gadobutrol during routine use.Material and MethodsProspective, non-interventional study in 80 centers in Germany. The primary outcome was the number of adverse drug reactions (ADR) following gadobutrol administration.ResultsA total of 3710 patients were included in the analysis, including 404 children (10.9%). A total of 6026 magnetic resonance imaging examinations of organs/organ systems and 872 magnetic resonance angiography examinations were performed. A total of 22 (0.59%) patients experienced at least one ADR. Nausea and vomiting were the most frequent ADRs, experienced by nine (0.24%) and three (0.08%) patients, respectively. One serious ADR was recorded (anaphylactoid reaction). No deaths were reported.ConclusionThis non-interventional study in 3710 patients confirmed gadobutrol as a safe and reliable contrast agent in adults and children.
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More From: Acta radiologica (Stockholm, Sweden : 1987)
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