Risk of Fatal Kidney Condition Results in New Warnings for Gadolinium-Based Contrasts Used in MRI and MRA Procedures

Gadolinium-based contrast agents (GBCAs) are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA). Earlier this year, the FDA announced it was requiring that GBCA's carry new warnings about the risk of nephrogenic systemic fibrosis (NSF) when these drugs are administered to certain patients with kidney dysfunction.

NSF involves the formation of excess fibrous connective tissue in the skin, joints, eyes and internal organs. Symptoms of NSF include scaling, hardening and tightening of the skin; red or dark patches on the skin; and stiffness.

Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury (AKI) or chronic, severe kidney disease. NSF has not been reported in patients with normal kidney function.

The three main GBCA drugs — Magnevist, Omniscan, and Optimark — are marketed by Bayer Healthcare, GE Healthcare, and Covidien, respectively.

Read the full FDA announcement here, which includes recommendations for screening patients prior to administration of GBCA's.