Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (MRI): marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance
Audience: Radiologists, Nephrologists, Dermatologists, other healthcare professionals
[UPDATED 09/28/2007] Manufacturers of Gadolinium-based contrast agents issued a Dear Healthcare Professional letter to inform healthcare professionals of the addition of a BOXED WARNING and revisions to the WARNING section of the prescribing information for Gadolinium-based contrast agents as listed above used in Magnetic Resonance Imaging (MRI).
[Posted 05/23/2007] 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.