Use of Gadolinium in MRI and MRA Linked to NSF/NFD in Patients With Renal Failure

Yael Waknine

Disclosures

January 02, 2007

January 2, 2007 — The US Food and Drug Administration (FDA) warned healthcare professionals last week about additional reports of nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD) in patients with renal failure exposed to gadolinium-based contrast agents.

As of December 21, 2006, the agency had received 90 reports of patients with moderate to end-stage renal failure who developed NSF/NFD within 2 days to 18 months after receiving Omniscan (made by Amersham Health, a subsidiary of GE Healthcare), OptiMARK (made by Mallinckrodt, Inc), or Magnevist (made by Berlex Laboratories, Inc) for magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA). Some patients had received a high dose of the product, while others had received only 1 dose.

Previously, the FDA’s information was limited to 25 cases in patients who had received Omniscan for MRA at doses higher than that recommended for MRI. The FDA notes that none of the 5 currently approved gadolinium products (Omniscan, OptiMARK, Magnevist, ProHance [made by Bracco Diagnostics, Inc], and MultiHance [made by Bracco Diagnostics, Inc]) are approved for use in MRA.

NSF/NFD was first identified in 1997 and although its cause remains unclear, appears to occur in patients with impaired renal function and acidosis. It is characterized by tight, rigid skin that renders bending of the joints difficult, and fibrosis that may lead to multiorgan failure and death.

There is no known treatment of NSF/NFD, although improved renal function (spontaneous or via renal transplantation) appears to slow or arrest its development and may even yield a gradual reversal of the condition.

The FDA is currently gathering additional information about NSF/NFD and is actively investigating whether gadolinium exposure is linked to the condition and whether other populations besides those with renal failure may be at risk.

However, 100% of NSF/NFD cases reviewed thus far (75 of approximately 215 cases worldwide) have occurred in patients who had received a gadolinium-based contrast agent for MRI or MRA. In addition, researchers have identified gadolinium in skin biopsies of patients with the condition.

Healthcare professionals are therefore advised to consider imaging methods other than MRI and MRA for patients with moderate to end-stage renal disease. Although NSF/NFD has been reported for only 3 of 5 gadolinium products, all of them potentially may be linked to a risk for NSF/NSD.

If alternatives to gadolinium-enhanced MRI or MRA are not feasible, prompt dialysis should be considered after the procedure. Although the utility of this measure for preventing or treating NSF/NSD in patients with impaired renal function has not been established, average excretory rates of gadolinium during consecutive hemodialysis sessions are 78%, 96%, and 99%, respectively.

In addition, patients at risk for NSF/NFD should be closely observed following MRI/MRA with gadolinium and instructed to contact their healthcare provider regarding potential symptoms of the condition, such as skin burning, itching, reddened/darkened patches and/or inflammation, hardening, and/or tightening; yellow raised spots on the sclera; and joint stiffness, limited range of peripheral movement, deep hip/rib pain, and/or muscle weakness.

Healthcare professionals are encouraged to report potential cases of NSF/NFD to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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