EVALUATION OF THE CLINICAL SAFETY OF GADODIAMIDE INJECTION, A NEW NONIONIC MRI CONTRAST-MEDIUM FOR THE CENTRAL-NERVOUS-SYSTEM - A EUROPEAN PERSPECTIVE

Gadodiamide injection is a new nonionic paramagnetic, extracellular co ntrast medium. Its safety at a dose of 0.1 mmol/kg body weight was eva luated in a large European multicentre trial on adults referred for co ntrast-enhanced MRI of the central nervous system. Safety analysis was performed on 2102 patients, in whom adverse events during and up to 2 4 h after injection were recorded. Adverse events related or possibly related to gadodiamide injection were observed in 102 patients. Inject ion-associated reactions classified as discomfort (sensation of heat o r coldness, pain or pressure at the injection site) occurred in 37 pat ients (1.8%) and other adverse events (e. g. headache, nausea) were ob served in 65 patients (3.1%). No serious adverse event was reported. E fficacy analysis, performed on 2273 patients, and based on comparison of T1- and T2-weighted images before and T1-weighted images after inje ction showed that more diagnostic information was obtained after gadod iamide injection in 1424 (62.6%) patients; management of 386 (17.0%) p atients was affected by the new information given and that a new diagn osis was made in 755 (33.3%) patients. Gadodiamide injection was shown to be safe and well tolerated. It represents a nonionic alternative t o the current products for MRI of the central nervous system.