FDA Drug Safety Communication

FDA is requiring changes in the drug label for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).

NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury (AKI) or chronic, severe kidney disease (with a glomerular filtration rate or GFR < 30 mL/min/1.73m2). Higher than recommended doses or repeat doses of GBCAs also appear to increase the risk for NSF.

The revised labeling will enhance the safe use of GBCAs by recommending that healthcare professionals:

- Not use three of the GBCA drugs--Magnevist, Omniscan, and Optimark--in patients with AKI or with chronic, severe kidney disease. These three GBCA drugs are contraindicated in these patients.

- Screen patients prior to administration of a GBCA to identify those with AKI or chronic, severe, kidney disease. These patients appear to be at highest risk for NSF.

- Use the clinical history to screen patients for features of AKI or risk factors for chronically reduced kidney function.

- Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the need for the diagnostic information is essential and not available with non-contrasted MRI or other alternative imaging modalities.

- Monitor for signs and symptoms of NSF after a GBCA is administered to a patient suspected or known to have impaired elimination of the drug.

- Do not repeat administration of any GBCA during a single imaging session.

Approved gadolinium based contrast agents:

- Ablavar (gadofosveset trisodium)

- Eovist (gadoxetate disodium)

- Magnevist (gadopentetate dimeglumine)

- Multihance (gadobenate dimeglumine)

- Omniscan (gadodiamide)

- Optimark (gadoversetamide injection)

- Prohance (gadoteridol)

View the full FDA Drug Safety Communication on FDA.gov