FDA calls for boxed warning for gadolinium-based MRI contrast agents

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The U.S. Food and Drug Administration (FDA) put out an advisory requesting that contrast agent manufacturers include a new boxed warning on the product labeling of all gadolinium-based contrast agents used in magnetic resonance imaging (MRI) scans.

FDA said the warning should state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and potentially fatal, disease known as nephrogenic systemic fibrosis (NSF).

The warning would also state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing severe kidney problems.

Patients with NSF develop thickening of the skin and connective tissue. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment at this point.

FDA first notified healthcare professionals and the public about the gadolinium-related risks for NSF last summer.

Gadolinium-based contrast agents are used to improve the visibility of internal structures when patients undergo an MRI. The five gadolinium-based contrast agents that have been approved for use in the United States are Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance; (gadobenate dimeglumine); and Prohance (gadoteridol).

More: www.fda.gov/cder/drug/infopage/gcca/default.htm