Until recently, it was believed that MRI contrast agents were some of the safest solutions used on humans. Very few side effects and adverse reactions were reported and many of those issues were very mild. Then, in 2006 researchers discovered a plausible link between the use of Gadolinium based MRI contrast agents and the development of a debilitating condition called Nephrogenic Systemic Fibrosis. The condition reportedly developed when patients with impaired renal function received an injection of a Gadolinium based MRI contrast agent prior to an MRI procedure. Out of the cases reviewed by the US Food and Drug Administration, all patients had impaired renal function or renal failure and all received a Gadolinium based MRI contrast agent injection prior an MRI. The cases all developed within two days to eighteen months of receiving the initial injection.
The first cases of Nephrogenic Systemic Fibrosis were discovered in 1997 and the first medical references about the condition were written in 2000. Nephrogenic Systemic Fibrosis is a condition that causes a progressive fibrosis of the skin, soft tissue, and internal organs of an individual. When involving the skin, the condition causes thickening patches located on the hands, feet, arms, and legs which creates a painful itching or burning sensation in the skin. As the skin tightens, it restricts the movement of the joints causing the patient to slowly lose their mobility. Over time, the skin can become so tight and stiff that attempting movement can break a bone.
As Nephrogenic Systemic Fibrosis progresses, the soft tissue beneath the affected areas of skin will begin to calcify. This causes the tissue to stiffen and harden, further restricting the movement of the patient. If Nephrogenic Systemic Fibrosis spreads to the internal organs, it causes the same damage resulting in the thickening and scarring of the affected organs. 5% of all cases of Nephrogenic Systemic Fibrosis are fatal because of progressive organ failure. The condition was first noted in patients undergoing dialysis who had received large doses of Gadolinium based MRI contrast agents prior to MRI or MRA procedures. Patients undergoing dialysis for renal failure have the highest risk of developing the condition.
Most patients that receive a Gadolinium based MRI contrast agent prior to an MRI procedure are not at risk for developing Nephrogenic Systemic Fibrosis because their renal function is normal. Only patients with impaired renal function or renal failure have been found to develop the condition. Although the development of Nephrogenic Systemic Fibrosis has been definitively linked to only three of the approved Gadolinium based MRI contrast agents, the US Food and Drug Administration believes that any of the five approved agents could cause the development of the condition. The cause of cases of Nephrogenic Systemic Fibrosis occurring following the injection of a Gadolinium based MRI contrast agent remains unknown, as not all patients with impaired renal function develop the disorder. Research continues to understand Nephrogenic Systemic Fibrosis and to find an effective treatment or cure for the disorder.