Gadolinium MRI NSF Injuries are a Risk Kidney Patients Need to Know AboutFeb 5, 2008 | Parker Waichman LLP
Keywords: Injury | Gadolinium | Kidney | NSF | Dye | Contrast
Kidney patients need to know that MRI procedures that involve the use of gadolinium contrast dyes could put them at risk of developing Nephrogenic Systemic Fibrosis (NSF). Unfortunately, there are no alternatives for gadolinium contrast dyes available at this time, and sometime such an MRI is truly necessary. For that reason, doctors must take added precautions to lessen the chance that kidney patients undergoing MRI with gadolinium contrast dyes develop NSF
NSF is a debilitating disease that 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 contrast agents play a role in its development is fast becoming irrefutable. Dutch scientists made the first connection between NSF and gadolinium in 2006. Since then, 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.
FDA Asked Manufactures of Gadolinium Contrast Dyes to Add a Black Box Warning to the Product Labels NSF Risks
The Food & Drug Administration (FDA) asked the manufactures of gadolinium contrast dyes to add a black box warning to the product labels about NSF risks in 2007. The FDA also warned that people with kidney disease should avoid gadolinium contrast agents. However, this is not always possible. If an MRI with a gadolinium contrast dye is required, the FDA has warned that the dose of the gadolinium contrast agent should not exceed that recommended in the product's label and that a repeat administration of the gadolinium contrast agent should not be performed until enough time has passed to allow for the gadolinium contrast agent from the first MRI to be eliminated from the body. The FDA recommends that patients already undergoing dialysis receive a dialysis treatment shortly following administration of a gadolinium contrast dye. Dialysis may help eliminate the gadolinium from the body, however it is not known if this will actually prevent NSF.
The FDA has also warned that the use of gadolinium contrast dyes in a procedure call Magnetic Resonance Angiography (MRA) could put kidney patients at an even greater risk of developing NSF because these procedures often use far more gadolinium than a typical MRI. The FDA has not approved the use of gadolinium contrast dyes for use in MRA.