New data on GBCA safety indicate risk of renal complications 'exceedingly low'
As gadolinium-based contrast agents (GBCAs) have evolved over the years, so too have the risks associated with their use. Now, new data suggest that the odds of experiencing one of the most concerning side effects of GBCA administration are “exceedingly low."
Nephrogenic systemic fibrosis (NSF) is a potentially fatal disease that progressively causes the skin and underlying tissues to harden; the rare condition also can cause muscles and tendons to contract. It was linked to GBCA use in individuals with severe renal function in the early 2000s, eventually prompting the U.S. Food and Drug Administration to issue a public health advisory.
Since then, GBCAs have come a long way, with many modern agents on the market containing significantly less gadolinium. The American College of Radiology categorizes GBCAs as Group 1 or Group 2; Group 1 agents have been involved in significantly more cases of NSF compared to Group 2 agents, which include macrocicylic agents like gadobenate (MultiHance), gadobutrol (Gadavist), and gadoterate (Dotarem).
Since regulatory bodies have stepped in, there has been a marked reduction in reports of NSF cases following GBCA administration. Now, experts have conducted new research on the subject in the hopes of quantifying the risk of NSF in vulnerable patients who are given modern day GBCAs for imaging.
“Although there has been a dramatic reduction in suspected NSF cases, it is possible that (a) cases have been diagnosed but not reported or (b) NSF has been misdiagnosed as another condition,” Cory Trankle, MD, with the division of cardiology at the Pauley Heart Center, Virginia Commonwealth University, and colleagues noted. “The aim of this study was to use a large deidentified database to perform a ‘worst-case scenario’ analysis of these two possibilities, examining whether there might still be—and if so, the magnitude of—residual risk of NSF with contemporary GBCAs in patients with advanced renal dysfunction.”
The team reviewed data from the TriNetX U.S. Network on adult patients with who had been diagnosed with stage 4 or 5 chronic kidney disease or end stage renal disease and received GBCAs between 2010 and 2025. Health records were reviewed to identify any instances of NSF within one year of contrast administration; patient characteristics and comorbidities also were reviewed to determine whether additional factors contributed to a diagnosis of NSF.
Data on more than 73,000 adults were available. Of those, just 36 (0.05%) and 542 (0.74%) patients with advanced chronic kidney disease or end stage renal disease were diagnosed with possible nephrogenic systemic fibrosis. In comparison, these figures were 36 (0.05%) and 518 (0.71%) in a group of healthy controls without renal issues. The rates were consistent across all contrast agents.
The authors suggested their findings “have significant potential clinical implications,” possibly indicating a risk of misdiagnosed NSF post-gadolinium administration for some.
Read more about the team’s findings here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.