The US Food and Drug Administration recently issued an alert to the healthcare community warning of an increased risk of the development of Nephrogenic Systemic Fibrosis in patients with impaired renal function or renal failure who have received a Gadolinium based contrast agent prior to an MRI procedure. The alert, which was issued in December of 2006, details 90 cases of Nephrogenic Systemic Fibrosis that developed in patients with impaired renal function within two days to eighteen months after receiving an injection of a Gadolinium based contrast agent.
A research team from Yale University, which contains the world’s leading authority on cases of Nephrogenic Systemic Fibrosis, recommends that the aggressive use of dialysis should be used as soon as possible after the MRI procedure to remove the Gadolinium based contrast agent from the body of the patient. They believe that two dialysis sessions within 24 hours of the completion of the MRI procedure using a Gadolinium based contrast agent will prevent the development of Nephrogenic Systemic Fibrosis by removing the Gadolinium from the body. In patients with normal renal function, Gadolinium is removed from the body by the kidneys but in patients with impaired renal function, the kidneys may not be strong enough to remove the Gadolinium from the body allowing it to build up and become toxic.
There is no effective treatment available for Nephrogenic Systemic Fibrosis and the only thing that seems to reverse the condition is an improvement in renal function. The experts at Yale believe that by placing the patient on dialysis immediately following the MRI procedure, the contrast agent is cleared from the patient’s body, minimizing the risk of developing Nephrogenic Systemic Fibrosis. The best course of action to manage Nephrogenic Systemic Fibrosis is to avoid the occurrence of the condition in the first place. The first round of dialysis will remove up to 80% of the Gadolinium from the body and the second round will make the body 95% clear.
There are five FDA approved Gadolinium based contrast agents that could potentially cause the development of Nephrogenic Systemic Fibrosis in patients with impaired renal function, although only three have been positively linked to the disorder. The three associated with the development of the condition are gadoversetamide (OptiMark, Mallinckrodt, St. Louis, Missouri), gadopentetate dimeglumine (Magnevist, Berlex Imaging, Montville, New Jersey), and gadodiamide (Omniscan, GE Healthcare, Princeton, New Jersey). All are approved for use in MRI procedures and are commonly used “off-label” for MRA procedures.
Although the US Food and Drug Administration doesn’t actually recommend dialysis to avoid the development of Nephrogenic Systemic Fibrosis, they do say that it may be necessary for patients with impaired renal function to undergo dialysis if they received a Gadolinium based contrast agent for the enhancement of MRA images, as the MRA procedure requires much higher doses of a Gadolinium based contrast agent to be effective. To date, there is no treatment regiment utilizing dialysis to remove a Gadolinium based contrast agent from the body approved for use in patients with impaired renal function or renal failure. As research continues, using dialysis to prevent an occurrence of Nephrogenic Systemic Fibrosis will be one of many treatment options explored.