Gadolinium is a contrast agent used in MRIs that give a greater contrast between normal and abnormal tissue in the body and brain. Gadolinium is injected into the vein and causes abnormal areas to appear very bright on the MRI. In recent years Gadolinium based agents have been linked to serious kidney disease. Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy are both new kidney diseases that have affected patients that have received MRIs using Gadolinium based contrast agents.
On May 23, 2007, the FDA ordered black-box warnings for all gadolinium-based contrast agents for magnetic resonance imaging, detailing an increased risk for nephrogenic systemic fibrosis (NSF) with kidney disease patients. The FDA first notified health care professionals and the public about the gadolinium side effects for NSF in June 2006. Information on the risks was updated in December 2006.
The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan®, a gadolinium based contrast agent, and took the MRA test. The FDA is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD.
The recent May 2007 FDA black box warning alerts doctors that:
Patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF).
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