Fibrosis warning added to MRI contrast agents

June 4, 2007

A new boxed warning has been added to the labeling for five gadolinium-based contrast agents used to improve the visibility of internal structures during MRI scans. This came after the FDA received reports of the risk of developing nephrogenic systemic fibrosis (NSF), a potentially fatal disease causing thickening of the skin and connective tissues that inhibits their movement.

A new boxed warning has been added to the labeling for five gadolinium-based contrast agents used to improve the visibility of internal structures during MRI scans. This came after the FDA received reports of the risk of developing nephrogenic systemic fibrosis (NSF), a potentially fatal disease causing thickening of the skin and connective tissues that inhibits their movement. According to the agency, the reports have identified the development of NSF after both single and multiple administrations of the agents. Omniscan (gadodiamide, GE Healthcare) was the agent cited most often, followed by Magnevist (gadopentetate dimeglumine, Bayer Schering Pharma) and OptiMARK (gadoversetamide, Mallinckrodt). The other two agents affected are ProHance (gadoteridol) and Multihance (gadobenate dimeglumine), both manufactured by Bracco Diagnostics. The new warning states that patients with severe kidney insufficiency—or those with any degree of kidney impairment who also are waiting for and have just had liver transplantation or have chronic liver disease—are at risk for developing NSF. The FDA suggests that patients be screened for kidney problems prior to receiving one of these agents and that the recommended doses for the agents not be exceeded.

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