A Food and Drug Administration advisory panel recommended approval of a new MRI contrast agent Friday.

U.S. advisors voted 16-0 in favor of a new Bayer AG imaging drug, gadobutrol. The FDA usually follows panel recommendation, but a final decision will not be made until March 14.
Gadobutrol is a stronger version of gadolinium-based contrast agents, which are used with magnetic resonance imaging scans of the central nervous system. Last year the FDA issued a black-box warning for gadolinium-based contrast agents about the potentially fatal skin disorder nephrogenic systemic fibrosis.

The FDA panel voted 15-1 that gadobutrol did not need the strongest warning against use in kidney disease patients. FDA reviewers said the drug appeard to carry a lower NSF risk. Lower risk drugs include an NSF warning, but do not recommend against all uses in kidney disease patients, who are particularly at risk of developing NSF.

Bayer has reported 10 NSF cases since gadobutrol was approved in Europe in 1998. Two patients received only gadobutrol, while others were given another gadolinium-based contrast agent.

If you or someone you know has developed nephrogenic systemic fibrosis or a similar condition after being exposed to gadolinium-based contrast agents during an MRI scan, a gadolinium attorney of Williams Kherkher can help. To learn more, contact our offices today at 800-761-3187.