The U.S. FDA has asked manufacturers to include a new boxed warning for severe kidney insufficiency patients on the product labeling of all gadolinium-based contrast agents for MRI.
The requested warning would state these patients are at risk for developing a debilitating and potentially fatal disease, known as nephrogenic systemic fibrosis (NSF). It would also state that patients in the process of liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency.
"FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease," said Steven Galson, MD, director of FDA's Center for Drug Evaluation and Research.
The companies that will be affected by the new warning are: Bayer Schering Pharma, Magnevist; GE Healthcare, Omniscan; Mallinckrodt, OptiMARK; Bracco Diagnostics, ProHance and Multihance.