FDAnews Device Daily Bulletin

FDA ISSUES SAFETY ALERT FOR MRI CONTRAST REAGENTS

June 12, 2006
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The FDA has posted safety information on its MedWatch site for gadolinium-containing contrast agents used in magnetic resonance imaging (MRI). The products in question include Omniscan, OptiMARK, Magnevist, ProHance and MultiHance.

The agency is evaluating safety issues related to gadolinium-containing contrast agents and nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NFD), a disease that occurs in patients with kidney failure. "New reports have identified a possible link" between NSF/NFD and exposure to gadolinium-containing contrast agents at high doses for a procedure known as magnetic resonance angiography (MRA), the FDA said. "The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan, a gadolinium-containing contrast agent, and took the MRA test," the agency said.

The FDA is investigating whether exposure to a gadolinium-contrast agent for MRA is associated with NSF/NFD and whether some patients who received gadolinium-containing contrast agents developed the condition.

The alert can be viewed at http://www.fda.gov/medwatch/safety/2006/safety06.htm#Gadolinium (http://www.fda.gov/medwatch/safety/2006/safety06.htm#Gadolinium).