[Clinical evaluation of the tolerability of gadodiamide, a new nonionic contrast agent in MRI of the central nervous system]

Gadodiamide injection (Gd-DTPA-BMA) is a new non-ionic paramagnetic contrast agent for which the safety at the dose 0.1 mmol/kg was evaluated during a European multicentre study on a large population of adult patients who had an MR examination of the central nervous system with contrast medium. The safety analysis was performed on 2,102 patients by recording the adverse events observed during injection and up to 24 hours after the injection. Adverse events due or probably due to gadodiamide injection were observed in 102 patients (4.4%) with injection-site associated discomfort (heat, coldness, pain at the injection site) in 37 patients (1.8%) and adverse events other than discomfort (headache, nausea, vomiting) in 35 patients (3.1%). No adverse events of severe intensity or death were reported during the trial. Gadodiamide injection was shown to be safe and well tolerated and represents a non-ionic alternative to the current products in the field of MR imaging of the central nervous system.