| FDA Orders Label Changes for Gadolinium-Based Contrast Agents |
The U.S. Food and Drug Administration (FDA) announced today that it will require significant label changes for gadolinium-based contrast agents (GBCAs) in order to reduce the risk of nephrogenic systemic fibrosis (NSF).
The most significant label change is the recommendation that Omniscan, Magnevist and Optimark NOT be used on people with chronic, severe kidney disease, such as dialysis patients, or those with acute kidney injury (AKI). This follows the determination by FDA staff last fall that Omniscan, Magnevist and Optimark are the gadolinium-based contrast agents most likely to cause NSF.
The new labeling also recommends that healthcare professionals:
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Screen patients prior to administration of a GBCA to identify those with AKI or chronic, severe, kidney disease. These patients appear to be at highest risk for NSF.
- Use the clinical history to screen patients for features of AKI or risk factors for chronically reduced kidney function.
- Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the need for the diagnostic information is essential and not available with non-contrasted MRI or other alternative imaging modalities.
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Monitor for signs and symptoms of NSF after a GBCA is administered to a patient suspected or known to have impaired elimination of the drug.
- Not repeat administration of any GBCA during a single imaging session.
The complete text of the FDA's Safety Announcement may be found HERE.
Unfortunately, this label change comes too late for some people with kidney disease or AKI who were injected with Omniscan, Magnevist and Optimark and as a result, developed NSF. Symptoms of NSF include scaling, hardening and tightening of the skin; red or dark patches on the skin; and joint stiffness. NSF can also cause fibrosis of internal organs that may lead to death. There is no effective treatment for NSF.
If you or a loved one developed any of the NSF symptoms listed above after treatment with a gadolinium-based contrast agent, you may have a legal claim. However, these and all personal injury claims are subject to statutes of limitations -- laws that place deadlines on when a claim may be made. Call the NSF lawyers at DeCarli Law for a free, no-obligation telephone consultation to learn your legal options. We are experienced helping people stricken with NSF, and can provide you with additional information about NSF and your legal rights. |