NSF and gadolinium contrast in MR examinations: FDA updates warning labels

September 13, 2010

The U.S. Food and Drug Administration has just updated the regulations regarding warning labels on gadolinium-based MRI contrast agents, due to the risk of NSF.
From now on, Magnevist, Omniscan, and Optimark would be required to carry labels with the following warning: “inappropriate for use among patients with acute kidney injury or chronic severe kidney disease.” The labels will emphasize the importance of screening patients to detect kidney dysfunction before MRI contrast administration.
According to the FDA, the latest review of the safety of the most widely used gadolinium-based contrast agents “determined that Magnevist, Omniscan, and Optimark are associated with a greater risk than other [gadolinium-based contrast agents] for NSF in certain patients with kidney disease.” However, all gadolinium-based contrast agents are under study, as data suggests that NSF may follow the administration of any of them.


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