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Public Health Advisory - Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI)

This information is not current.
The FDA has issued new information about this safety issue; please see Information on Gadolinium-Containing Contrast Agents.

6/8/2006
The FDA is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). An MRA test uses magnetic resonance imaging to take pictures of blood vessels. During an MRA test, a drug known as a gadolinium-contrast agent is injected into a patient’s vein so blood vessels can be distinguished from other nearby tissues.

The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan®, a gadolinium-containing contrast agent, and took the MRA test. The FDA is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD. While FDA conducts its investigation, the following recommendations are being provided to health care providers and patients:

  • Gadolinium-containing contrast agents, especially at high doses, should be used only if clearly necessary in patients with advanced kidney failure (those currently requiring dialysis or with a Glomerular Filtration Rate (GFR) = 15 cc/min or less).
  • It may be prudent to institute prompt dialysis in patients with advanced kidney dysfunction who receive a gadolinium contrast MRA. Although there are no data to determine the utility of dialysis to prevent or treat NSF/NSD in patients with decreased kidney function, average excretory rates of gadolinium are 78%, 96%, and 99% in the first to third hemodialysis sessions, respectively (Okada, et al, Acta Radiologica, vol 42 p. 339, May 2001).

Five gadolinium-containing contrast agents are FDA-approved for use during magnetic resonance imaging (MRI), a test that can look at internal body organs and tissues. The trade names of the U.S. approved gadolinium-containing contrast agents are: Omniscan, OptiMARK, Magnevist, ProHance, and  MultiHance. None of these drugs are FDA approved for MRA. The dose of gadolinium-containing contrast agent given to patients undergoing an MRA test is often higher (up to three times) than the approved dose for MRI.

NSF/NFD appears to occur in patients with kidney failure along with high levels of acid in body fluids a condition known as acidosis that is common in patients with kidney failure. Patients with NSF/NFD have tight and rigid skin making it difficult to bend joints. NSF/NFD may also result in fibrosis, or scarring, of body organs resulting in the inability of body organs to work properly and can lead to death. Diagnosis of NSF/NFD is done by looking at a sample of skin under a microscope.

Scientists first identified NSF/NFD in 1997 and the cause of NSF/NFD is unknown. Worldwide, there are approximately 200 reports of NSF/NFD.

The 25 cases of NSF/NFD were reported on May 29, 2006, by the Danish Medicines Agency. Among these, 20 cases occurred in Denmark and five cases occurred in Austria. The patients developed NSF/SFD within 3 months (range 2 weeks to 3 months) after receiving the gadolinium-containing contrast agent. The five patients from Austria are described in a publication: Grobner T. Gadolinium – a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis Nephrol dial Transplant. 21(4):1104-8.

The FDA has not yet determined whether exposure by patients with kidney failure to gadolinium-containing contrast agents during an MRA test causes NSF/NFD. The FDA is gathering additional information about NSF/NFD and investigating whether other patients who received gadolinium-containing contrast agents developed NSF/NFD.

The FDA urges health care providers and patients to report adverse event information to the FDA via the MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this page.
 

 

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