Nephrogenic systemic fibrosis and class labeling of gadolinium-based contrast agents by the Food and Drug Administration

Radiology. 2012 Oct;265(1):248-53. doi: 10.1148/radiol.12112783. Epub 2012 Aug 24.


In 2007, the Food and Drug Administration requested that manufacturers of all approved gadolinium-based contrast agents (GBCAs), drugs widely used in magnetic resonance imaging, use nearly identical text in their product labeling to describe the risk of nephrogenic systemic fibrosis (NSF). Accumulating information about NSF risks led to revision of the labeling text for all of these drugs in 2010. The present report summarizes the basis and purpose of this class-labeling approach and describes some of the related challenges, given the evolutionary nature of the NSF risk evidence. The class-labeling approach for presentation of product risk is designed to decrease the occurrence of NSF and to enhance the safe use of GBCAs in radiologic practice.

MeSH terms

  • Contrast Media / adverse effects*
  • Drug Labeling*
  • Gadolinium / adverse effects*
  • Humans
  • Magnetic Resonance Imaging*
  • Nephrogenic Fibrosing Dermopathy / chemically induced*
  • Nephrogenic Fibrosing Dermopathy / epidemiology
  • Nephrogenic Fibrosing Dermopathy / prevention & control
  • United States / epidemiology
  • United States Food and Drug Administration


  • Contrast Media
  • Gadolinium