The information FDA released in December 2006 said that patients with moderate renal insufficiency are at risk for developing NSF. Why has this changed?
The December information was based upon reports of NSF among patients with purportedly moderate renal insufficiency. Since issuing the information in December 2006, the FDA has received new information regarding these patients. Additional details have clarified that the patients actually were in acute renal failure at the time they received a GBCA. Considering this clarification, the FDA has not received reports of NSF among patients with normal renal function or moderate renal insufficiency.
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