FDA requires new warnings on gadolinium-based contrast agents
Five years after the food and Drug Administration first alerted medical professionals about a possible link between gadolinium-based contrast agents (GBCAs) and a serious kidney dysfunction known as Nephrogenic Systemic Fibrosis (NSF), the agency this week announced it is requiring changes to the drug’s professional labeling in an effort to minimize the risk. The agency noted that NSF after GBCAs has not been reported in patients with normal kidney function, and that patients at greatest risk for developing the condition after GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease.