Use of a group II gadolinium-based contrast agent (GBCA) in patients with stage 4 or 5 chronic kidney disease is associated with an extremely low risk of nephrogenic systemic fibrosis (NSF), according to new study findings published in JAMA Internal Medicine.

In a systematic review and meta-analysis of 16 studies and 4931 patients, the pooled incidence of NSF after administration of gadobenate dimeglumine, gadobutrol, gadoterate meglumine, or gadoteridol for contrast-enhanced magnetic resonance imaging (MRI) was 0%, with an upper bound of the 95% confidence interval of 0.07%.

Despite earlier FDA warnings, not all gadolinium-based contrast agents have the same risk of NSF, Sean Woolen, MD, MS, of the University of Michigan, Ann Arbor and colleagues explained.

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“The potential diagnostic harms of withholding group II GBCA for indicated examinations may outweigh the risk of NSF in this population,” they concluded.

Among the review’s limitations, other potential risks associated with group II gadolinium-based contrast agent, such as allergic-like reactions and gadolinium retention, were not assessed. The investigators also were unable to determine the risk of sequential group II gadolinium-based contrast agent exposures or the risk from group II gadolinium-based contrast agent administration in the setting of acute kidney injury.

In an accompanying editorial, Saugar Maripuri, MD, and Kirsten Johansen, MD, of the Hennepin County Medical Center and the University of Minnesota in Minneapolis, recommended cautious use of these group II agents in at-risk patients, including those receiving dialysis “provided patients are given the lowest possible dose, repeated exposures are avoided, and patients treated with hemodialysis receive it shortly after [gadolinium-based contrast agent] administration.” It is unclear how many patients in the meta-analysis received dialysis, they noted. 

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Woolen SA, Shankar PR, Gagnier JJ, et al. Risk of Nephrogenic systemic fibrosis in patients with stage 4 or 5 chronic kidney disease receiving a group II gadolinium-based contrast agent: A systematic review and meta-analysis. JAMA Intern Med. 2020;180(2):223-230. doi: 10.1001/jamainternmed.2019.5284

Maripuri S, Johansen KL. Risk of gadolinium-based contrast agents in chronic kidney disease—Is zero good enough? JAMA Intern Med. doi: 10.1001/jamainternmed.2019.5278