Original Statement Issued in June of 2006 by FDA:
"The FDA has learned of 25 foreign cases of Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with renal failure who underwent Magnetic Resonance Angiography (MRA) with Omniscan. Omniscan and other gadolinium-containing contrast agents are FDA approved for use in Magnetic Resonance Imaging (MRI) but not for MRA. Physicians should carefully assess the need for performing MRI with contrast in patients with advanced renal failure (those currently requiring dialysis or with a Glomerular Filtration Rate (GFR)≤15cc/min) and administer the minimal needed dose of contrast agent if MRI with contrast is necessary. The FDA is further evaluating the possible link between the use of gadolinium-containing contrast agents and development of NSF/NFD.
First identified in 1997,
NSF/NFD is almost exclusively found in patients with
renal failure and acidosis. Patients with this
condition develop fibrosis of the skin and
connective tissues throughout the body. The skin
thickening may inhibit flexion and extension of
joints, resulting in contractures. In addition,
patients may develop widespread fibrosis in other
organs. A skin biopsy is necessary to make a
definitive diagnosis. The disease is progressive and
may be fatal. Its cause is unknown.
Patients who receive gadolinium-containing contrast agents should be
aware of the following possible signs and symptoms
of NSF/NFD and advised to seek medical attention if
these occur: swelling and tightening of the skin;
difficulty extending the joints of arms, hands,
legs, and feet; weakness, reddened or darkened areas
on the skin; burning or itching of the skin; and
deep bone pain in the hips and ribs.
Physicians should be cautious regarding the use of
gadolinium-containing contrast imaging agents,
especially at high doses, in patients with advanced
renal failure (those currently requiring dialysis or
with a GFR≤15cc/min).
There are no data to determine the utility of dialysis to prevent or
treat NSF/NSD in patients with decreased renal
function who receive gadolinium contrast MRA.
However, prompt dialysis of these patients will
eliminate circulating gadolinium, with average
gadolinium excretory rates of 78%, 96%, and 99% in
the first to third hemodialysis sessions,
respectively.1 "
