Diagnosing nephrogenic systemic fibrosis in the post-FDA restriction era

J Magn Reson Imaging. 2015 May;41(5):1268-71. doi: 10.1002/jmri.24664. Epub 2014 Jun 5.

Abstract

The emergence of an association between gadolinium-based contrast agents (GBCA) and the rare condition nephrogenic systemic fibrosis (NSF) led to a warning in 2006 from the Food and Drug Administration (FDA) restricting the use of the GBCAs to patients with an estimated glomerular filtration rate of >30 mL/min/1.73m(2) . We discuss our experience with a post-FDA restriction presentation of NSF and subsequent patient death in which the prolonged lead-time of ∼5.5 years led to challenges in ensuring a secure diagnosis of NSF and establishing risk exposures. Accurate contemporary records of contrast administration and clinical factors alongside clinical and pathological expertise ensured that we were able to confidently diagnose NSF, despite the length of lead time and confounding factors.

Keywords: gadolinium; glomerular filtration rate; nephrogenic systemic fibrosis.

Publication types

  • Case Reports

MeSH terms

  • Aged
  • Contrast Media / adverse effects
  • Diagnosis, Differential
  • Drug Approval*
  • Gadolinium / adverse effects
  • Gadolinium DTPA / adverse effects*
  • Humans
  • Magnetic Resonance Imaging / adverse effects*
  • Magnetic Resonance Imaging / standards*
  • Male
  • Nephrogenic Fibrosing Dermopathy / diagnosis*
  • Practice Guidelines as Topic*
  • United States

Substances

  • Contrast Media
  • gadodiamide
  • Gadolinium
  • Gadolinium DTPA