FDA Toughens Warnings On MRI Contrast Agents

Law360, New York (September 9, 2010, 7:11 PM EDT) -- The U.S. Food and Drug Administration will now require gadolinium-based contrast agents used during MRI procedures to carry updated warnings on their labels indicating the risk that certain patients with kidney disease could develop a potentially fatal condition.

The FDA said in a notice Thursday that the GBCAs will have to bear warnings on their labels that certain patients with kidney disease could develop a rare and potentially fatal condition known as nephrogenic systemic fibrosis connected to use of the intravenous drugs.

The gadolinium-based contrast agents...
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