FDA Wants Boxed Warning for Gadolinium-Based MRI Dyes

WASHINGTON, D.C. - The FDA has asked the manufacturers of contrasting dyes used to enhance image quality during MRI procedures to include on their products a black box warning indicating a risk of developing a potentially fatal skin and connective tissue disorder.

According to a statement issued by the FDA on May 23, the dye makers should warn that patients with severe kidney disorders who receive contrasting agents containing gadolinium prior to undergoing MRI are at an increased risk of developing nephrogenic systemic fibrosis (NSF). Those with liver conditions are also at risk of developing the disease, which is characterized …