FDA Warns Doctors About Gadolinium-Based Contrast Agents

Today FDA warned doctors about gadolinium-based contrast agents used in magnetic resonance imaging (MRI). Some of the companies that provide gadolinium-based MRI dyes to radiologists include: Magnevist, MultiHance, ProHance, Omniscan, and OptiMARK.

FDA has requested the companies above to provide new warnings to doctors about the risk of nephrogenic systemic fibrosis (NSF) with the use of GBCAs in MRIs. 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 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.