US FDA Announces Gadolinium-Based MRI Contrast Agent Warning

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.

Background:
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 patients.

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 Reporting Program:

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 1-800-FDA-0178