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Public Health Advisory
Gadolinium-containing Contrast Agents for Magnetic Resonance
Imaging (MRI):
Omniscan, OptiMARK, Magnevist, ProHance, and
MultiHance
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 by phone
(1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at
http://www.fda.gov/medwatch/index.html.
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Gadolinium-Containing
Contrast Agents
Date created: June 8, 2006, updated May 23, 2007 |
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