FDA wants MRI contrast agent warning

May 23, 2007

The U.S. Food and Drug Administration wants a warning printed on the labels of all gadolinium-based magnetic resonance imaging contrast agents.

The requested boxed warning would state patients with severe kidney insufficiency who receive the chemicals used to enhance the quality of MRI images are at risk of developing a debilitating and a potentially fatal disease known as nephrogenic systemic fibrosis, or NSF.

In addition, the FDA wants the warning to state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk.

Gadolinium-based contrast agents are commonly used to improve the visibility of internal structures when patients undergo an MRI. Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents.

Copyright 2007 by United Press International

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