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| September 09, 2010 |
| FDA Orders Label Changes for Gadolinium-Based Contrast Agents |
| Posted By DeCarli Law |
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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. |
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| August 12, 2010 |
| After Years of Delay, Bayer Asks the FDA for Approval of Gadovist, its Safer Gadolinium-Based Contrast Long Available in Europe |
| Posted By DeCarli Law |
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The FDA has just accepted Bayer Schering Pharma's New Drug Application for Gadovist, a gadolinium-based contrast agent currently sold in Europe and other parts of the world, but not in the United States. A New Drug Application is the procedure a drug company uses to formally request the FDA to allow it to sell a drug in the United States.
Although Bayer's application for Gadovist is new, Gadovist itself is not. Gadovist has been approved for sale in the European Union since 1998. However, until recently, Bayer has not sought approval for selling it in the United States. This decision -- whatever its basis -- has put Americans at risk.
Gadovist has a macrocyclic molecular structure, which means the gadolinium ion is surrounded by an organic chelate. In contrast, Magnevist, the Bayer contrast agent sold in the United States, has a linear ionic molecular structure. Magnevist's molecular structure is less stable than Gadovist's macrocyclic structure. As a result, European regulatory agencies recognize than Magnevist is less safe than Gadovist. The EU equivalent of the FDA requires the Magnevist label to state that it is contraindicated (not recommended) for use on people with severe renal impairment. Gadovist does not have this restriction.
A gadolinium-based contrast agent's molecular stability has dire health consequences, especially for people with impaired renal function, like those on dialysis. If a gadolinium-based contrast agent breaks down within the human body, the person is at risk of developing nephrogenic systemic fibrosis (NSF). NSF, also known as nephrogenic fibrosing dermopathy (NFD), is an incurable disease characterized by hardening of the skin and other body tissues. The only known cause of NSF/NFD is the use of gadolinium-based contrast agents in medical procedures such as MRI, MRA and CT scans (CAT scans).
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| November 20, 2009 |
| European Health Agency to Label Gadolinium-Based Contrast Agents as High-, Medium-, or Low-Risk for Causing NSF |
| Posted By DeCarli Law |
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The European Medicines Agency (EMEA) issued a press release today, stating that it would begin classifying gadolinium-based contrast agents into three risk categories based on their likelihood of causing Nephrogenic Systemic Fibrosis (NSF). Of the brands labeled as high risk for NSF, three are sold in the United States. These are Omniscan, Magnevist and OptiMARK.
The EMEA is the European agency responsible for evaluating medicinal products. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) reviewed all gadolinium-based contrast agents because of their association with NSF, the serious and sometimes life-threatening condition characterized by the hardening of skin, joint, muscle and organ tissues. Because of the risk for people with kidney problems, the CHMP concluded that all gadolinium-based contrast agents should be classified as either high risk, medium risk, or low risk of causing NSF.
For high-risk contrast agents such as Omniscan, Magnevist and OptiMARK, the CHMP recommends contraindications in patients with severe kidney problems, in patients who are scheduled for or have recently received a liver transplant, and in newborn babies up to four weeks of age. For medium- and low-risk contrast agents, the CHMP recommends adding new warnings for use in patients with kidney problems and those awaiting a liver transplant. Vasovist and MultiHance are the contrast agents labeled by the EMEA as having a medium-risk of causing NSF that are sold in the United States. The only low-risk contrast agent sold in the United States is ProHance.
The EMEA’s categorization of gadolinium contrast agents is similar to the recent conclusions by FDA staff members that Omniscan, Magnevist and OptiMARK are the contrast agents with the greatest risk of causing NSF, which was reported in our previous blog post. However, the European health agency has gone further than the FDA will likely go. The CHMP recommends that laboratory tests be conducted before administration of any gadolinium-based contrast agents in order to screen people for kidney problems. Further, the CHMP recommends the following information for all gadolinium-based contrast agents:
- A warning that the elderly may be at particular risk of NSF due to impaired ability of their kidneys to clear gadolinium from the body.
- A statement that there is no evidence to support the initiation of hemodialysis to prevent or treat NSF in patients not already undergoing hemodialysis.
- A statement that the type and dose of contrast agent used should be recorded.
Hopefully, when the FDA holds its own committee meeting on December 8, 2009 to discuss warning labels for gadolinium-based contrast agents, it will follow the lead of the European health agency. A complete copy of today’s EMEA press release can be found HERE.
Before late 2007, although the manufacturers knew of the NSF risk, they did not inform doctors and patients in the United States that gadolinium-based contrast agents could cause Nephrogenic Systemic Fibrosis (NSF) when used on people with kidney problems, especially those undergoing dialysis. If you or a loved one had kidney problems and underwent a medical scan with a gadolinium-based contrast agent, you were at risk of developing NSF. Contact the MRI lawyers/NSF attorneys at DeCarli Law for a free consultation to learn more about your legal options if you think you may have NSF.
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| October 27, 2009 |
| Larger Doses and Repeated Use of Gadolinium-Based Contrast Agents Increase Risk of Nephrogenic Systemic Fibrosis (NSF) |
| Posted By DeCarli Law |
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A recently-published study concludes that larger and more frequent use of gadolinium-based contrast agents increases the risk of nephrogenic systemic fibrosis (NSF). Patients who received higher cumulative and total doses of gadolinium-based contrast agents had a higher risk of developing NSF than those who received lower doses. Abujudeh, et al., “Nephrogenic Systemic Fibrosis after Gadopentetate Dimeglumine Exposure: Case Series of 36 Patients,” Radiology, Oct. 2009.
The study focused exclusively on the risk of NSF from Magnevist (gadopentetate dimeglumine), Bayer Healthcare’s brand of gadolinium-based contrast agent. The study looked at 36 people who had been patients at Massachusetts General Hospital between 1998 and 2007 who had been injected with Magnevist, and no other brand of contrast agent. They were between 30 and 83 years old. All had stage 5 chronic kidney disease, with all but one on dialysis.
The study found that there was a 1.2 times increased risk of developing NSF with each 40-mL increase in cumulative Magnevist exposure. Further, as the cumulative exposure to Magnevist increased, there was a shorter time period between when they developed NSF and their last exposure to Magnevist. In short, your risk of getting NSF increases with each exposure to Magnevist. The authors of the study observed that their findings were consistent with similar findings for Omniscan, the brand of gadolinium-based contrast agent manufactured by GE Healthcare.
You may obtain a copy of the entire study HERE.
If you believe you or a loved one may have developed nephrogenic systemic fibrosis (NSF) after exposure to a gadolinium-based contrast agent, contact the NSF lawyers/NSF attorneys are DeCarli Law for a free consultation. If you have been diagnosed with NSF, you may be able to bring an MRI side effect lawsuit/gadolinium lawsuit.
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