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Evidence of Gadolinium MRI Contrast Dye Link to NSF Stronger than Ever

Dec 21, 2007 | Parker Waichman LLP

NSF (Nephrogenic Systemic Fibrosis), sometimes called NFD (Nephrogenic Fibrosing Dermopathy) is a rare disease that so far has affected only people with pre-existing kidney problems.  In 2006, researchers discovered a direct association between NSF and the use of Gadolinium MRI contrast dyes. Since that initial discovery, several other studies have reinforced the link between NSF and Gadolinium MRI contrast dyes.  In 2006, the Food & Drug Administration (FDA) first warned doctors of this Gadolinium side effect.  Then, in 2007 the FDA ordered the manufactures of Gadolinium contrast dyes to add a black box warning – the strictest type of FDA warning -- to their product labels advising of the risk of NSF to people with kidney problems.

NSF
was first seen in patients in 1997, and it wasn’t mentioned in medical literature until 2000. NSF 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 can progress to the point of causing severe stiffness in joints, and it can lead to death.

There is currently no cure for NSF and no one understands its specific cause. However, the evidence that Gadolinium MRI contrast agents play a role in its development is fast becoming irrefutable. Researchers at Yale University have reported that 95-percent of those with NSF had an MRI that involved a Gadolinium MRI contrast dye two to three months before their symptoms appeared.  Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with Gadolinium MRI contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

For patients with NSF, 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 can lead to death. Unfortunately, there are no effective treatments for NSF, although some patients have improved following a kidney transplant.

Gadolinium MRI contrast dyes 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 dyes unless it is absolutely necessary.  Unfortunately, there are not yet any alternatives to gadolinium based MRI contrast agents.  


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