Gadolinium Contrast Agents Required to Include New Warning

The U.S. Food and Drug Administration (FDA) issued a news release Sept. 9, 2010, requiring that contrast agents containing gadolinium carry a new warning on their labels. The labels will be required to warn about the risk of using gadolinium in certain patients because it can lead to a rare, sometimes fatal kidney disease called nephrogenic systemic fibrosis (NSF).

NSF is characterized by skin hardening, tightening, scaling, containing red or dark patches, and stiffness. The disease can also damage internal organs, which can be fatal.

Three gadolinium-based contrast agents (GBCAs) pose an increased danger to patients with impaired kidney function. These agents are:

  • Magnevist, sold by Bayer Healthcare
  • Omniscan sold by GE Healthcare
  • Optimark, sold by Covidien

The labels will be required to say that these contrast agents should not be used in patients with acute kidney injury or chronic severe kidney disease. The GBCA labels will stress that patients must be tested for these conditions before being given the drug.

GBCAs are injected intravenously to enhance the images produced by magnetic resonance imaging or magnetic resonance angiography. These radiological imaging techniques help doctors see details of body organs, blood vessels or other tissues in order to check them for abnormalities.

The development of NSF recently has been linked to the use of GBCAs. In May 2007, the FDA asked the makers of all GBCAs to include a black box warning (the most emphatic type of warning a drug label carries) on all such contrast agents. There were reports that patients developed NSF after receiving one or more injections of GBCAs.

Patients with normal kidney function or mild to moderate kidney insufficiency have not contracted NSF. Patients at greatest risk of getting NSF after the use of GBCA include:

  • Those having problems eliminating the drug
  • Those with acute kidney injury
  • Those with chronic or severe kidney disease

The revised labels will:

  • Warn healthcare professionals not to use the three contraindicated agents
  • Advise screening of patients before administering a GBCA
  • Use the patient’s clinical history to check for impaired kidney disease
  • Follow a patient after giving the drug to watch for signs of kidney problems
  • Caution healthcare professionals not to use GBCA more than once during an imaging session.
  • Not give gadolinium a second time until the first dose is eliminated

While the three agents mentioned previously should not be used in patients with impaired kidney function, they are approved for general use. Other approved GBCAs are Ablavar, Eovist, Multihance and Prohance.

For more information or to speak with an attorney, contact a nephrogenic systemic fibrosis lawyer.

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Gadolinium Contrast Agents Required to Include New Warning

The U.S. Food and Drug Administration (FDA) issued a news release Sept. 9, 2010, requiring that contrast agents containing gadolinium carry a new warning on their labels because it can lead to nephrogenic systemic fibrosis (NSF). Read More »

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