Update on Avoiding Gadolinium - Containing Contrast Agents in Patients with Renal Failure

Posted on April 1, 2006

Gadolinium is a rare earth metal with unusual paramagnetic properties that make it useful for magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA), as a contrast agent to enhance images and to evaluate blood vessels. However, the FDA has not approved Gadolinium for use in MRA.

In June of 2006, the FDA issued a public health advisory to alert doctors about the possible link between Gadolinium-based contrast agents and Nephrogenic Systemic Fibrosis (NSF). At that time, there were 25 known cases of NSF in patients with kidney failure. Then on May 23, 2007, the FDA send out an updated statement regarding gadolinium asking the manufacturer to include a black box warning on the product about the risk of developing NSF.

Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), is a skin condition that is often described as a swelling and tightening of the skin, usually in the extremities, resulting in decreased mobility of joints. The condition may develop over a short period of days or could take weeks to fully develop. Symptoms of NSF include swelling, hardening and tightening of the skin, joint stiffness, or darkened patches on the skin. Over time, NSF becomes worse and can cause death, and unfortunately, there is no known treatment for NSF.

If you or a loved one has been diagnosed with nephrogenic systemic fibrosis, or if you are experiencing the symptoms associated with the disease from gadolinium used in a MRI or MRA, you may have a claim against the manufacturers of these gadolinium-based contrast agents. Please contact us today so we can help you get in touch with experienced Gadolinium attorneys to help you with your claim.

FDA Previous Update on Gadolinium - April 2006

FDA has received reports of 65 more cases of a rare, possibly fatal disease in patients with renal failure who receive a contrast agent containing gadolinium while undergoing certain imaging procedures. The disease, called Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD), is characterized by fibrosis of the skin and internal organs.

These new reports are in addition to cases that were reported on in mid-2006. In the new reports, the affected patients had end-stage kidney failure, and had either Magnetic Resonance Angiography (MRA) or Magnetic Resonance Imaging (MRI) with a gadolinium-based contrast agent. Their NSF/NFD began from 2 days to 18 months after exposure to the contrast agent. Although many of these patients received large amounts of the contrast agent, some received only one dose. In addition, researchers have found gadolinium deposits in the skin of patients who developed NSF/NFD.

There are currently five FDA-approved gadolinium-based contrast agents. Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. These agents are approved for use during an MRI scan, but not for MRA.

Although NSF/NFD has been reported for only 3 of these 5 agents, FDA believes that there is a potential for NSF/NFD to occur with the use of any of the approved gadolinium-based agents.

Because of this, FDA is recommending that whenever possible, health care professionals choose imaging methods other than MRI or MRA with gadolinium for patients with moderate to end-stage kidney disease. If these patients must receive a gadolinium-based agent, consider prompt dialysis following the MRI or MRA.

Patients should be aware of the signs and symptoms of NSF/NFD and report these to their doctor. They include swelling and tightening of the skin, red or dark skin patches and difficulty flexing or extending the joints.

Finally, FDA is asking health care professionals and patients to report possible cases of NSF/NFD through FDA's MedWatch program.