Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (MRI): Magnevist, MultiHance, Omniscan, OptiMARK, ProHance

Published: Wed May 23 00:00:00 -0400 2007

FDA notified healthcare professionals of the Agency's request for the addition of a boxed warning and new warnings about the risk of nephrogenic systemic fibrosis (NSF) to the full prescribing information for all gadolinium-based contrast agents (GBCAs). The new prescribing information FDA is requesting highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m²) and patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. Healthcare professionals should avoid the use of a GBCA in these patients unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging. Previous MedWatch Alerts: