New Warning Added to Gadolinium Products

FDA Changes Labeling on Gadolinium-based Contrast Agents- Risk of Nephrogenic Systemic Fibrosis. The affected products include: Ablavar (gadofosveset trisodium), Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), Multihance (gadobenate dimeglumine), Omniscan (gadodiamide), Optimark (gadoversetamide injection), Prohance (gadoteridol)

The FDA is requiring changes in the labeling for gadolinium-based contrast agents (GBCAs) to reduce the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. There are no known reports of NSF in patients with normal kidney function.  Healthcare professionals are advised to screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease.

See the the MedWatch safety alert for more information