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Gadolinium Based MRI Contrast Agents Put Kidney Patients at Risk for NSF/NSD

Nov 9, 2007 | Parker Waichman LLP
MRI Contrast Dye

Gadolinium Based MRI Contrast Agents have been Implicated in at least 1,000 Cases of Debilitating Disorder Called NSF

Gadolinium based MRI contrast agents have been implicated in at least 1,000 cases of a debilitating disorder called Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NSD) around the world.  This horrible disease causes a buildup of collagen in tissues, leading to a severe thickening and hardening of the skin.   NSF/NSD can completely immobilize patients, and in severe cases it can lead to death.

NSF/NSD is a rare disease that so far has affected only people with pre-existing kidney problems.  The first case of NSF/NSD was reported in 1997, and it wasn’t mentioned in medical literature until 2000.   NSF/NSD leads to excessive formation of connective tissue in the skin and internal organs.  It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF/NSD can progress to the point of causing severe stiffness in joints, and it can lead to death.

There is Currently No Cure for NSF/NSD, and No One Understands its Specific Cause

There is currently no cure for NSF/NSD, and no one understands its specific cause.  However, it is widely believed that gadolinium based MRI contrast agents play a role in the development of this devastating disorder.   Researchers at Yale University have reported that 95-percent of those with NSF/NSD had an MRI that involved a gadolinium based contrast agent two to three months before their symptoms appeared.   Several other studies have also found a link between NSF/NSD and gadolinium based MRI contrast agents.  The connection between gadolinium and NSF/NSD is so strong that earlier this year, the Food & Drug Administration (FDA) requested that that the manufacturers of gadolinium based contrast agents update their products’ labels to include a black box warning regarding the risk of NSF/NSD in patients with kidney problems.  The FDA also started a monitoring program to track the frequency of NSF/NSD related to gadolinium contrast agents.

Gadolinium based MRI contrast agents are used in MRIs because they make it far easier for a diagnostician to differentiate between normal and abnormal tissue.  While the tests can be done without the gadolinium based contrast agent, they are nowhere near as effective.  The FDA has warned that patients with kidney problems not be given gadolinium based MRI contrast agents unless it is absolutely necessary.  Unfortunately, there are not yet any alternatives to gadolinium based MRI contrast agents.

For patients with NSF/NSD, life can become a living hell.   Their skin can become so hardened that it resembles marble, while joints stiffen to the point that movement becomes impossible.  The disease can also affect the heart, lungs and liver, and NSF/NSD can lead to death.  Unfortunately, there are no effective treatments for NSF/NSD, although some patients have improved following a kidney transplant.

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