The United States Food and Drug Administration on Tuesday approved a sixth gadolinium-based MRI contrast agent.

According to Dr. Libero Marzella, acting division director of the Division of Medical Imaging products in the Food and Drug Administration Center for Drug Evaluation and Research, the agency approved the MRI contrast agent gadobutrol, which is marketed as Gadavist by Bayer Pharmaceuticals. Gadavist is the sixth gadolinium-based contrast agent approved by the FDA. 

"Gadavist MRI scans improved the visualization of lesions in the central nervous system, when compared to MRI scans without contrast," Marzella said. 

Marzella did not comment on the link between gadolinium-based contrast agents and the potentially fatal condition Nephrogenic Systemic Fibrosis. He did say that Gadavist will carry a black box warning detailing the risk of the rare skin condition. The FDA gave Gadavist a lower-risk classification for NSF, saying it was "not one of the GBCAs that is contraindicated in patients with acute kidney injury."

If you have developed Nephrogenic Systemic Fibrosis after being administered a gadolinium-based MRI contrast agent, please contact a Gadolinium Attorney of Williams Kherkher at 800-761-3187.