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Certain contrast agents used in magnetic resonance imaging — gadolinium-based products made by Bayer AG, GE and others — will now carry the U.S. Food and Drug Administration’s strongest, “black box” warning.
The U.S. FDA indicated that it would start adding its strongest ‘black box’ warnings to gadolinium based contrast agents used in MRIs by May of next year.
New findings from researchers at Wake Forest University Baptist Medical Center and colleagues suggest why some people with kidney failure can develop a rare tightening and swelling of the skin and other organs, including the lungs and heart.
Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NFD), a painful conditions that has been linked to the use of gadolinium based contrast agents used in Magnetic Resonance Imaging (MRI), could be more prevalent than once thought.
Kidney disease patients with a newly identified disease called nephrogenic systemic fibrosis (NSF) are at increased risk of death, U.S. researchers report. The researchers also concluded that exposure to gadolinium, a contrast agent used in MRI scans, is a significant risk factor for developing NSF, a painful and debilitating condition characterized by a thickening and hardening of the skin. It usually affects the arms and legs but can also affect internal organs. The disease can progress so rapidly that some patients are immobilized and confined to a wheelchair within weeks.
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