New warnings for gadolinium-based contrast agents

The FDA is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of nephrogenic systemic fibrosis (NSF), a rare and potentially fatal condition, if the drug is administered to certain patients with kidney disease. Three of the GBCAs - Magnevist, Omniscan, and Optimark - will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration.

The FDA recommends that healthcare professions:

  • Estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function
  • Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the imaging is essential and not available without contrast
  • Monitor for signs and symptoms of NSF if a GBCA is administered to a patient with acute kidney injury or chronic, severe kidney disease
  • Administer a GBCA only once during an imaging session

GBCAs are intravenous drugs approved by the FDA for use with magnetic resonance imaging or magnetic resonance angiography to help detect abnormalities of body organs, blood vessels, and other tissues.

For more information visit www.fda.gov/Drugs/DrugSafety/ucm223966.htm.