EVALUATION OF THE CLINICAL SAFETY OF GADO DIAMIDE INJECTION (OMNISCAN(R)), A NEW NONIONIC MR CONTRAST AGENT FOR THE CENTRAL-NERVOUS-SYSTEM

Gadodiamide injection (Gd-DTPA-BMA) is a new non-ionic paramagnetic co ntrast agent for which the safety at the dose 0.1 mmol/kg was evaluate d during a European multicentre study on a large population of adult p atients who had an MR examination of the central nervous system with c ontrast medium. The safety analysis was performed on 2,102 patients by recording the adverse events observed during injection and up to 24 h ours after the injection. Adverse events due or probably due to gadodi amide injection were observed in 102 patients (4.4%) with injection-si ta associated discomfort (heat, coldness, pain at the injection site) in 37 patients (1.8%) and adverse events other than discomfort (headac he, nausea, vomiting) in 35 patients (3.1%). No adverse events of seve re intensity or death were reported during the trial. Gadodiamide inje ction was shown to be safe and well tolerated and represents a non-ion ic alternative to the current products in the field of MR imaging of t he central nervous system.