FDA is requiring changes in the professional labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction.
GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography.
NSF is a rare and potentially fatal disorder characterized by the hardening of the skin, eyes and internal organs. The
association of NSF with GBCAs can be traced back to 2006 when the FDA
reported cases of NSF in renal failure patients. Since then, the
regulator has been monitoring the effects of all GBCAs for their
potential to cause this serious disease.FDA warning:
The FDA released a mandate
on September 9, 2010, which requires a black box warning label–the strongest in the industry–
to be issued on the use of specific GBCAs. This directive calls for a
label update for these GBCAs due to the risk of nephrogenic systemic
fibrosis (NSF) if they are used in patients with kidney disease.
Seven MRI drugs containing gadolinium have been approved by the FDA, and all can cause NFS in patients with kidney disease. But three in particular are “chemically more unstable” than the others, according to the FDA, meaning they are more likely to release the toxic chemical. These three are Bayer Healthcare’s Magnevist, General Electric Healthcare’s Omniscan and Covidien’s Optimark.
Rather than pull the drug, the FDA is requiring stronger labeling that instructs physicians to use the drug only on patients who have healthy kidneys. Healthcare professionals should screen patients prior to
administration of a GBCA to identify those with acute kidney injury or
chronic, severe, kidney disease. See the Drug Safety Communication for
the complete list of recommendations to healthcare professionals and
Healthcare professionals and patients are encouraged to
report adverse events or side effects related to the use of these
products to the FDA's MedWatch Safety Information and Adverse Event
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form
or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to
FDA: Deptember 12, 2007: Important Drug Warning for Gadolinium-Based
FDA: Information on Gadolinium-Containing Contrast Agents
BfArm: Main information on contrast media containing gadolinium: Risk of nephrogenic systemic fibrosis (NSF) (in German)
Related EVISA Resources
Link Database: Toxicity of Gadolinium compounds
Materials Database: Gadolinium Materials
Related News EVISA News, March 25, 2010: Publication on the separation of Gd-based contrast agents awarded EVISA News, May 4, 2009: Gadolinium speciation analysis in search for the cause of nephrogenic systemic fibrosis (NSF)
EVISA News, April 17, 2009: Gadolinium-based MRI contrast agents found intact in the outlet of a waste water treatment plant
last time modified: September 15, 2010