A public health advisory was recently issued by the US Food and Drug Administration warning about a severe disorder associated with advanced kidney disease and the use of gadolinium based contrast agents used during magnetic resonance imaging (MRI). As of December 2006, the agency had received over 90 reports of patients suffering from advance kidney disease developing a debilitating disease called nephrogenic systemic fibrosis, also known as nephrogenic fibrosing dermopathy, after using a gadolinium based contrast agent and undergoing an MRI. When the FDA performed an in depth analysis of 75 of the cases, they found that all had moderate to late stage kidney disease, all had received an injection of a gadolinium based contrast agent, and all had undergone an MRI. Because of this connection, the FDA has recommended that all patients with moderate to late stage kidney disease requiring an imaging procedure be given alternative treatments.
Nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD) is a disorder in which the skin of the patient becomes thick and hard. The condition can also affect the internal organs of the patients, causing them to thicken and scar as well. Patients experiencing NSF/NFD report a sensation of burning or itching in their skin while it visibly swells, hardens, and tightens. In some cases, patients have reported the appearance of dark or red patches on the skin. NSF/NFD causes joints to become stiff and patients suffering from the condition may have difficulty moving their arms, hands, legs, and feet. Yellow spots may appear in the white portion of the eye, accompanied by bone pain deep in the hips and ribs and significant muscle weakness. Symptoms of NSF/NFD can appear as soon as two days and as long as eighteen months after the exposure to the gadolinium based contrast agent. Many of the patients affected received a high or multiple doses of the contrast agent, but the condition has also occurred in patients that only received a single dose.
It is not yet clear why individuals with advanced kidney disease who have been exposed to gadolinium based contrast agents have an increased risk of developing NSF/NFD. There are five of these agents approved by the FDA for use during MRI procedures. These include Magnevist (manufactured by Bayer Healthcare Pharmaceuticals), MultiHance (manufactured by Bracco Diagnostics, Inc.), Omniscan (manufactured by GE Healthcare), OptiMARK (manufactured by Mallinckrodt Inc.), and ProHance (also manufactured by Bracco Diagnostics, Inc.). Although NSF/NFD has only been linked to three of the gadolinium based contrast agents, the FDA believes that the condition can occur with the use of any of them.
NSF/NFD is a rare condition, with less than 300 confirmed cases worldwide. Of the cases that have been reviewed, all of them developed the condition after receiving an injection of a gadolinium based contrast agent. The agents have also been found in the skin biopsies of patients suffering with NSF/NFD. The FDA is now advising against the usage of gadolinium based contrast agents in patients with advanced kidney disease and if the agents must be used, the patient should undergo prompt dialysis after the MRI procedure has been completed. There is no effective treatment available for NSF/NFD, but the condition can be slowed, and sometimes reversed, by improving the renal function of the patient.