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The U.S. Food and Drug Administration has requested manufacturers of gadolinium-based contrast agents—used to enhance the overall quality of magnetic resonance imaging (MRI)—to include a boxed warning about the products’ health risks.
The warning states that patients who receive gadolinium-based agents and have a severe kidney insufficiency are at a risk for developing a potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF). It also explains that patients who have just had, or are about to have, a liver transplant and those who have chronic liver disease are also at high risk when given these agents.
Patients who have NSF develop a thickening of the skin and connective tissues that prevents them from moving properly and can often result in broken bones. The thickening skin can have a negative impact on internal organs as well.
The FDA notified health care professionals of the risks of gadodiamide and NSF in June 2006 and again in December.
(Source: http://www.fda.gov/)
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