FDA MedWatch - Update on MRI Contrast Agents Containing Gadolinium and Nephrogenic Fibrosing Dermopathy

The FDA has issued a Public Health Advisory to notify healthcare professionals
that it has received additional information about a new disease, known
as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy
(NSF/NFD), which may occur in patients with moderate to end-stage kidney
disease after they have had a Magnetic Resonance Imaging (MRI) or
Magnetic Resonance Angiography (MRA) scan with a gadolinium-based
contrast agent. FDA has received reports of 90 patients with moderate to
end-stage kidney disease who developed NSF/NFD after they had an MRI or
MRA with a gadolinium-based contrast agent. FDA is notifying health
care providers and patients that: 1] Patients with moderate to end-stage
kidney disease who receive an MRI or MRA with a gadolinium-based
contrast agent may get NSF/NFD which is debilitating and may cause
death, 2] Patients who believe they may have NSF/NFD should contact
their doctor, 3] When a patient with moderate to end-stage kidney
disease needs an imaging study, select imaging methods other than MRI or
MRA with a gadolinium-based contrast agent for the study whenever
possible, and 4] FDA asks health care professionals and patients to
report possible cases of NSF/NFD to the FDA through the MedWatch
program.

Read the complete MedWatch 2006 Safety summary, including links to the
updated information page, Public Health Advisory, and previous June 2006
alert, at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#Gadolinium