Recent research has shown Gadolinium, the contrast agent used in MRI scans, can lead to the debilitating, and potentially fatal disease known as nephrogenic systemic fibrosis (NSF).
This debilitating disease is characterized by the thickening and tightening of the skin, scarring to body organs, yellow spots on the eyes, and stiffness in the joints. The U.S. Food and Drug Administration (FDA) requested that manufacturers of all gadolinium based contrast agents include a new boxed warning on their product labeling.
Contrast Agents Containing Gadolinium
Only five gadolinium based contrast agents have been approved for use in the United States: Schering AG unit Berlex’s Magnevist (gadopentetate dimeglumine), GE Healthcare’s Ominiscan (gadodiamide); Mallinckrodt’s OptiMARK (gadoversetamide); Bracco Diagnostic’s MultiHance;(gadobenate dimeglumine); and Bracco Diagnostic’s Prohance (gadoteridol).
Health care professionals and the public were first notified by the FDA about gadolinium’s risks for NSF in June 2006. “FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease,” said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research.
“This latest action demonstrates FDA’s continuing vigilance about ensuring the safety of drug products once they enter the marketplace.” Patients scheduled to undergo an MRI should be screened for kidney problems first. The FDA has received no reports, to date, concerning patients with normal kidney function developing NSF. One study discovered that there is a 4 percent chance that a patient with severe kidney problems will develop NSF after receiving an injection with a gadolinium based contrast agent.
Patient Describes Developing NSF After MRI Scan
In an open public meeting of an FDA advisory committee, Celeste Castillo Lee, a hospital administrator from North Carolina who suffers from nephrogenic systemic fibrosis shared the story of how she developed NSF following an MRI scan using a gadolinium based contrast agent. She had the MRI scan to look for a blood clot that turned out to be scar tissue from a previous surgical procedure.
Four days after the MRI scan she started to develop symptoms of nephrogenic systemic fibrosis. Her ankles swelled and she developed incredible pain. Her skin began to tighten and the symptoms moved up her body, first the calves, then the knees, then the thighs and finally her torso. She sought treatment from several doctors and finally a biopsy showed traces of the gadolinium and NSF was diagnosed.
Celeste said it was an incredibly painful and debilitating disease with no cure. Though she can still walk she said 75 percent of patients afflicted with NSF are confined to wheelchairs. She appeared before the committee to help prevent further patients experiencing what she has experienced. The panel recommended that the Food and Drug Administration effectively ban, for patients with severe kidney disease, the use of Omniscan, and Optimark as contrast agents in MRI scans.
If you or a loved one has had a MRI scan using the contrast agent Gadolinium and you have developed NSF as a result, please contact a personal injury attorney at the Law Offices of Nadrich & Cohen, we can help you.