FDA panel backs MRI contrast agent

January 26, 2011

A Food and Drug Administration (FDA) panel has voted unanimously to recommend approval of a new contrast agent for MRI scans, despite concerns that the agent might increase the risk of nephrogenic systemic fibrosis (NSF) in patients, MedPage Today reports.

Washington - A Food and Drug Administration (FDA) panel has voted unanimously to recommend approval of a new contrast agent for MRI scans, despite concerns that the agent might increase the risk of nephrogenic systemic fibrosis (NSF) in patients, MedPage Today reports.

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 16-0 that gadobutrol (Bayer) is safe and effective for use with diagnostic MRI scans of the central nervous system. If approved, gadobutrol would join five other gadolinium-based contrast agents (GBCAs) currently on the market.

NSF, a skin disorder that also can also affect joints, eyes and internal organs and can be fatal, has been associated with high doses of other GBCAs. Prior to the panel’s decision, FDA reviewers were concerned that gadobutrol’s unique strength and dosing - it is twice as strong as other GBCAs at half the typical injection volume - might lead to accidental overdose if physicians mistakenly assume it has the same strength at the same dosage as the other drugs.

Gadobutrol was first approved in Europe in 1998. Since then, Bayer has reported three cases of overdose, none of which resulted in NSF.