Causes - MRIs
The overwhelming majority of known NSF cases, at this point, ( 90%) represent patients who had previously received gadodiamide when having an MRI (Omniscan; GE Healthcare, Princeton, NJ) and who also have chronic and acute kidney disease. Nevertheless, there have been reports of NSF cases associated with other agents. In one particular study 57 cases of NSF associated with prior gadolinium-based MR contrast agent administration were reported to the U.S. Food and Drug Administration (FDA) MedWatch Web site (http://www.fda.gov/medwatch). Of the 57 cases of NSF reported to the FDA to date, six are definitely associated with gadopentetate dimeglumine (Magnevist; Berlex Imaging, Montville, NJ); two, with gadoversetamide (OptiMARK; Mallinckrodt, St Louis, Mo); and three, with gadodiamide plus gadoversetamide associated; for three other cases, the associated specific gadolinium-based MR contrast agent was not definitively identified. For the remainder, gadodiamide was the associated agent. The FDA has sufficient confidence to issue on May 23, 2007 a FDA black box warning. A black box warning is the most serious warning the FDA can request be added to a drug, short of calling for the drug to be pulled off the market.
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