New Warnings Required for Gadolinium-Based Contrast Agents

The FDA is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of nephrogenic systemic fibrosis (NSF) if administered to certain patients with kidney disease.

Three GBCAs—Magnevist, Omniscan, and Optimark—will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease, according to the FDA. All GBCA labels will emphasize the need to screen patients to detect these types of kidney problems prior to administration.

NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Symptoms can include scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. NSF can lead to death, particularly if it involves organs, the FDA said.