Gadolinium MRI and risk factors for the debilitating disease nephrogenic systemic fibrosis (NSF) are currently being investigated by the Food and Drug Administration (FDA). An MRI with gadolinium is a type of MRI that uses a contrast agent with special magnetic properties to help increase the visibility of organs and tissues. Since its approval in 1988, MRI with gadolinium has been administered to millions of patients.

Magnetic resonance imaging (MRI) is a diagnostic study that has been used since the 1980's. An MRI uses strong magnets and radio waves to create computer generated three-dimensional images of the body. When an MRI study is performed, radio waves are pulsed through the patient's body causing movement in hydrogen atoms in the body's cells. Different parts of the body react to the radio waves with predictable patterns. These patterns are displayed as three-dimensional pictures on a computer screen.

A gadolinium MRI is a special type of study where the patient is injected with gadolinium. For MRI studies using gadolinium the procedure usually involves two MRIs. The first MRI is administered to get a baseline study. The second study involves injecting the patient with gadolinium and then taking a second MRI. Gadolinium is a naturally occurring metallic element that has special magnetic properties. Gadolinium gives the treating physician and radiologist a more detailed picture of the patient's internal organs, tissues, bones and vessels. MRI with gadolinium is used because it provides additional diagnostic information compared to an MRI without contrast. The Gadolinium for MRI agent is also referred to as gadolinium-based contrast agents (GBCA). Five GBCAs are approved for magnetic resonance imaging in the United States: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance.

Evidence has been increasing regarding the risk of nephrogenic systemic fibrosis (NSF) in patients with severe kidney problems who receive gadolinium during an MRI procedure. Nephrogenic systemic fibrosis appears to occur in patients with kidney failure. Patients with kidney disease or on kidney dialysis are at increased risk because gadolinium is primarily eliminated by the body through the kidneys.

Recent studies have shown an association between NSF and patients with kidney disease that have a gadolinium MRI. Unfortunately, there has been little research or clinical trials that have studied patients with kidney problems and gadolinium contrast agents. NSF causes fibrosis of the skin and connective tissues throughout the body. The patient's skin thickens leading to a loss of mobility and in some cases causing death. There is no known treatment or cure for NSF. NSF has only been reported in patients with severe renal dysfunction (kidney disease).

The Food and Drug Administration (FDA) has requested that the different manufacturers of gadolinium MRI contrast agent (GBCA) revise their product labels to include a new warning that describes the increased risk of developing nephrogenic systemic fibrosis (NSF). The FDA is continuing to review gadolinium for MRI as more studies and reviews become available regarding the link between gadolinium and NSF.