FDA Wants Warning On MRI Contrast Agents
MRI scans are as common as x-rays these days. But here is a news report that will make you think twice before you enter the belly of that scanner. On Wednesday the Food and Drug Administration issued a statement asking manufacturers of certain contrast agents, used in patients who get MRI scans, to place a black-box warning on the agents so patients are aware of the risks involved. Apparently these agents can be lethal to patients who have severe kidney problems, according to an article posted on CNN.
According to this article, the warning would involve five gadolinium-based contrast agents, some of which are manufactured by General Electric Co.’s health care unit as well as BAY, an arm of Bayer and Tyco. FDA officials say these agents, when used on someone with severe kidney problems, “could cause a debilitating and potentially fatal disease called nephrogenic systemic fibrosis.” Among others who are at risk are patients who are undergoing a liver transplant or those with chronic liver disease.
FDA officials say this condition, commonly referred to as NSF, can cause thickening of the skin and connective tissues and restricts their mobility resulting in broken bones. This type of fibrosis may also develop in the diaphragm, thigh and lower abdominal and lung vessels. NSF is a debilitating condition that results in gradual deterioration and may eventually lead to death. The agents in question are used to enhance visibility of internal organs when patients undergo an MRI. According to FDA officials, the contrast agents are not required for an MRI to be done.
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