Magnevist and Nephrogenic Systemic Fibrosis

The first cases of Nephrogenic Systemic Fibrosis were discovered in 1997 with the first medical references detailing the condition written in 2000. The condition only affects individuals with impaired renal function or renal failure and causes the skin and connective tissues in the body to thicken and harden. The typical symptoms of Nephrogenic Systemic Fibrosis include darkened patches appearing on the skin, a severe itching or burning sensation beneath the skin, skin becoming so tight that it begins to restrict movement. The condition affects males and females equally and can be found in individuals of every age, from children to seniors. Nephrogenic Systemic Fibrosis is a progressive condition and can ultimately prove to be fatal.

There is no known cure available for Nephrogenic Systemic Fibrosis and current treatments are often ineffective. The only option that has a consistent effect on the progression of the condition seems to be the improvement of renal function, which has been shown to halt the progression of the condition and in rare cases, began to reverse the damage done by the disorder. The exact reason for the development of Nephrogenic Systemic Fibrosis in some individuals remains unknown, the agents suspected of causing the development of the condition include surgery, vascular injury, and exposure to Gadolinium based contrast agents.

In 2006, the FDA issued two public health advisories warning healthcare professionals and patients with impaired renal function about the increased risk of developing Nephrogenic Systemic Fibrosis when exposed to a Gadolinium based contrast agent such as Magnevist. In all of the cases of Nephrogenic Systemic Fibrosis that the FDA had investigated, every individual had received an injection of a Gadolinium based contrast agent prior to an MRI procedure in the 2 days to 18 months before the onset of the condition. Although only three of the five approved Gadolinium based contrast agents were conclusively linked to these patients developing Nephrogenic Systemic Fibrosis, the FDA believes that the increased risk applies to all of the approved Gadolinium based contrast agents.

The manufacturer of Magnevist, Bayer Healthcare Pharmaceuticals, reports that they are cooperating fully with the US Food and Drug Administration and health authorities investigating the issue. Reports have been received linking the development of Nephrogenic Systemic Fibrosis to an injection of Magnevist, but those cases are still under review. Out of the 78 reports received by the manufacturer claiming an association between Magnevist and the development of Nephrogenic Systemic Fibrosis, 27 of the cases have been deemed plausible, 5 of the cases have been deemed unlikely, and 46 of the cases need more information to draw a conclusion. To date, Magnevist has been used in more than 80 million applications throughout the world and is available for use in more than 100 countries.