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« FDA Urges Caution in Giving Cough and Cold Medicine to Children | Main | JASN reports on possible role of gadodiamide and Nephrogenic Systemic Fibrosis »

August 27, 2007

New Warnings for MRI Contrast Agents Containing Gadolinium

The FDA has announced that labeling for MRI and MRA imaging contrast agents that contain gadolinium will have stronger new warnings. The contrast agents are often used to improve the visibility of internal structures when patients undergo MRI/MRA procedures. Five of the contrasting agents have been approved in the US: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. The new boxed warning describes risks and necessary screening procedures for a serious condition related to gadolinium exposure called nephrogenic systemic fibrosis (NSF). NSF is characterized by fibrosis of the skin, muscle and internal organs. It is debilitating and potentially fatal. The warning will state that certain patients have a higher risk of developing NSF if they are given any of these gadolinium-based agents. Specifically those affected with severe acute or chronic renal failure and those with acute renal failure of any severity who have hepato-renal syndrome or are currently preparing for or are healing from a liver transplant. Hepato-renal syndrome is a term used for a group of diseases involving both the liver and kidney. Clinicians should avoid using these products with high-risk patients unless the diagnostic information is essential and cannot be obtained any other way.

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