Gadolinium is a contrast agent that helps distinguish between normal and abnormal tissue in the body when used with magnetic resonance imaging (MRI) and/or CT scans. Gadolinium was approved for use in 1988 and has been used in millions of studies since. It is the preferred contrast agent for people with chronic kidney disease. The use of iodine-containing contrast agents is still a common cause of hospital-acquired acute renal failure and is associated with increased mortality & morbidity. On the other hand, gadolinium-based agents, like Omniscan Contrast Dye, have been reported to be safe, well tolerated, and have shown almost no nephrotoxicity in recommended doses.
Nephrogenic systemic fibrosis (NSF), described in 2000, is an emerging systemic disorder characterized by widespread tissue fibrosis. NFS was not known to the medical community before March 1997 and some medical authors suggest that the sudden occurrence of the disease in the last 8 years makes it likely that a new agent or technique of examination causes it. Currently, there is no effective treatment available for NSF.
Based on recent research, NSF occurs only in patients with advanced or in end stage kidney disease and is strongly related to the use of gadolinium dyes for MRI scans. At this time, there are no known cases of NSF in patients with normal kidney function.
In a pivotal study in 2006 conducted by Dr. T. Grobner it was noted that 5 of their 9 patients diagnosed with NSF had received a MRI involving use of Omniscan Contrast Dye, a gadolinium-based contrast agent manufactured by GE. This study was followed shortly by other studies and case reports showing a similar strong association.
Currently, little is known about NSF. However, due to recent studies, the association is so strong, that both the FDA and the company that makes gadodiamide have sent out warnings about the use of gadolinium-containing contrast in patients with advanced kidney disease.
Pending further studies, experts are recommending that gadolinium-based MRI scans be avoided in patients with advanced kidney disease until more is known about the true causal link between gadolinium and NSF.
