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Home » FDA ISSUES SAFETY ALERT FOR MRI CONTRAST REAGENTS

FDA ISSUES SAFETY ALERT FOR MRI CONTRAST REAGENTS

June 9, 2006

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).

KEYWORDS FDAnews Device Daily Bulletin

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