As stated in the 2017 ACR guidelines: “It is now known that there are differences in the likelihood of a patient developing NSF after exposure to different formulations of GBCAs. Recent data suggests that the risk of NSF is linked to the gadolinium binding strength of the chelates that form GBCAs, with most cases associated with weaker, linear chelates. Importantly, there have been no reported cases of NSF in the literature since 2009 with broader community use of macrocyclic GBCAs. After guidelines based on ACR/FDA recommendations where applied, the incidence of the disease fell from 36.5/100,000 patients to 4/100,000 patients 9. A recent publication from a single institution has recently demonstrated a positive impact of screening for NSF risk factors prior to administration of gadolinium. As of October 2007, of the 431 of the cases reported from the FDA Freedom of Information system to the authors of a review paper in the topic, 283 were associated with Omniscan, 125 were associated with Magnevist, 20 were associated with Opti-MARK, 9 were associated with ProHance (8 of which were also exposed to other agents), and 10 were associated with MultiHance (8 of which were also exposed to other agents) 8. The incidence of NSF in patients with severe renal dysfunction (GFR < 30) varies from 0.19 to 4% 5-7. One meta-analysis including the seven large series of patients with NSF reported an odds ratio of 26.7 (95% CI = 10.3-69.4) for development of NSF after gadolinium administration in patients with impaired renal function (GFR < 30) 4. Many published series have suggested an increased risk of NSF development in patients exposed to high doses and multiple doses of gadolinium, however cases with single doses (0.1 mmol/kg) have also been reported. Other comorbidities have been described in patients who developed NSF, including acute pro-inflammatory states, metabolic acidosis, increased iron, calcium or phosphate levels, immunosuppression, vasculopathy, high dose erythropoietin therapy and infection 3. Many of the reported cases of NSF have been in patients before or after liver transplant. Considering this clarification, FDA has not received reports of NSF among patients with normal renal function or moderate renal insufficiency”. Additional details have clarified that the patients actually were in acute renal failure at the time they received a gadolinium based contrast agent. Since issuing the information in December 2006, FDA has received new information regarding these patients. In 2009, the FDA determined that moderate renal impairment (eGFR of 30-60) was NOT a risk factor for NSF, reversing the position it had taken in December 2006, and stated 2 “The December information was based upon reports of NSF among patients with purportedly moderate renal insufficiency. The exact etiology of NSF is unclear but most reported cases have been documented in patients with severe acute or chronic renal failure, with a glomerular filtration rate (GFR) 30 1. NSF is generally seen in the middle-aged, but has also been reported in the elderly and in children. This rare but serious systemic disease is characterized by fibrosis of the skin and other tissues throughout the body. This changed in 2006 when the FDA first reported the association between nephrogenic systemic fibrosis (NSF) and intravenous gadolinium administration. The administration of intravenous gadolinium-containing contrast media was historically considered safe in patients with impaired renal function.
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