New Warnings for MRI Contrast Agents Containing Gadolinium

Posted on April 29, 2008

The labeling for imaging contrast agents that contain gadolinium will soon have strong new warnings. These contrast agents are often used to improve the visibility of internal structures when patients undergo MRI procedures. Five of them have been approved in the US: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance.

The new boxed warning describes risk factors and 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 a gadolinium-based agent. They include those with severe renal failure, whether acute or chronic, and those with acute renal failure of any severity who have hepato-renal syndrome or are in the perioperative period around liver transplantation. Clinicians should avoid using gadolinium based contrast agents with high-risk patients unless the diagnostic information is essential and cannot be obtained any other way.

The new labeling will contain several other recommendations, including:

• Before using these agents, all patients should be evaluated for renal failure either by obtaining a medical history or conducting laboratory tests.

• When administering these products, do not exceed the dose recommended in the product labeling. And do not re-administer these agents until enough time has elapsed to ensure that the prior dose has been eliminated from the body.

• After administering a gadolinium-based contrast agent, consider prompt dialysis for patients already receiving hemodialysis.

It is unknown whether dialysis prevents NSF, but data indicate that it does speed up the elimination of the agent from the body.

Additional Information:

FDA MedWatch Safety Alert. Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (MRI): Magnevist, MultiHance, Omniscan, OptiMARK, ProHance. May 23, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Gadolinium