Caution on Gadolinium-Containing Contrast Agents (Aug. 2006) Video

FDA has learned of a rare, possibly fatal disease among patients with renal failure who underwent Magnetic Resonance Angiography (MRA) using Omniscan, a contrast agent containing gadolinium. The disease is called Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NFD). To date, NSF/NFD has been found almost exclusively in patients with renal failure. The disease is characterized by fibrosis of the skin and connective tissues.

Five gadolinium-containing contrast agents have been approved in the U.S. for use with MRI. However, none have been approved for MRA, where the doses are up to three times higher than for MRI. But these agents have been used off-label for MRA.

At this point a causal relationship between gadolinium-containing contrast agents and NSF/NFD has not been established. FDA is investigating the reports received so far, other data bases and the medical literature to try to answer this question. In the meantime, FDA says that physicians should be cautious about using gadolinium-containing contrast agents in patients with advanced renal failure.

Although there are no data to determine the utility of dialysis to prevent or treat NSF/NSD in patients with decreased kidney function, there is evidence that dialysis can accelerate the excretion of gadolinium. So it may be prudent to institute prompt dialysis in patients with advanced kidney dysfunction who receive a gadolinium contrast MRA.

Patients should be aware of the signs and symptoms and report these to their health professional. These include swelling and tightening of the skin, and difficulty in flexing or extending the joints. Cases of NSF/NFD that may be related to gadolinium-containing contrast agents should be reported through the MedWatch system.

Additional Information:

FDA MedWatch Safety Alert 2006 - Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance. June 8, 2006.
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Gadolinium

MedWatch Voluntary Reporting by Health Care Professionals.
http://www.fda.gov/medwatch/report/hcp.htm

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