Gadolinium News |
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| This page contains the latest news from newspapers across Canada and the United States discussing the warnings on Gadolinium-based contrast agents. | |
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FDA Orders Warnings on MRI Contrast Agents |
| The Wall Street Journal May 23, 2007 |
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The Food and Drug Administration said Wednesday it is asking manufacturers of certain contrast agents used in patients undergoing magnetic resonance imaging, or MRI scans, to place a black-box warning on the agents' packaging. The FDA said the warning, which would apply to five gadolinium-based contrast agents, including ones made by General Electric Co.'s health-care unit and a unit of Bayer AG, would state that patients with severe kidney insufficiency are at risk for developing a debilitating, and a potentially fatal, disease known as nephrogenic systemic fibrosis, or NSF. |
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FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Imaging |
| FDA May 23, 2007 |
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The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI). The requested warning would state 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). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity. |
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FDA Orders Black Box Warning for Gadolinium-Based Contrast Agents |
| MedPageToday May 23, 2007 |
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The FDA today ordered black-box warnings for all gadolinium-based contrast agents for magnetic resonance imaging, detailing an increased risk for nephrogenic systemic fibrosis with kidney-disease patients. The warning alerts clinicians of possible severe kidney insufficiency in patients at risk for nephrogenic systemic fibrosis, a potentially fatal disease, who receive gadolinium-based agents. The boxed message also warns that the nephrogenic systemic fibrosis risk extends to patients with chronic liver disease including those just before or after liver transplantation. |
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