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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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| 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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| November 17, 2009 |
| FDA Staff: Omniscan, Magnevist and OptiMARK Gadolinium-Based Contrast Agents Most Likely to Cause NSF |
| Posted By DeCarli Law |
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In a recently-prepared FDA document, staff members conclude that Omniscan, Magnevist, and OptiMARK are the gadolinium-based contrast agents with the highest risk of causing Nephrogenic Systemic Fibrosis (NSF). A much lower NSF risk is associated with Prohance and Multihance. These conclusions are contained in a briefing document prepared for an upcoming FDA committee meeting that will consider changing the warning labels to reflect these differing risks.
The briefing document was prepared for an Advisory Committee meeting to be held on December 8, 2009, which will re-evaluate the current warnings required for gadolinium-based contrast agents. Currently, all gadolinium-based contrast agents must have the same warning, regardless of brand. This decision was made in 2007, based on the information available at that time about NSF. However, the warning labels may change if the recommendations of FDA staff members are adopted.
Various FDA staff reports contained in the briefing document recommend heightened warning labels for the three more dangerous contrast agents: Omniscan, Magnevist, and OptiMARK. A lesser warning would be required for Prohance and Multihance, which are associated with fewer cases of NSF. In fact, the makers of Optimark have already changed their warning label on their own, as reported in a previous blog post, contraindicating use of their product for patients with severe renal disease and those awaiting a liver transplant.
The FDA documents provide further support for what has already become apparent in NSF lawsuits: most people develop NSF after exposure to Omniscan, Magnevist, and OptiMARK.
If you or someone you know has developed Nephrogenic Systemic Fibrosis (NSF) after exposure to gadolinium-based contrast agents during an MRI or other medical procedure, consider contacting the MRI lawyers at DeCarli Law for a free, no obligation consultation.
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| November 10, 2009 |
| New OptiMARK Label Warns Against Any Use on Patients with Severe Renal Failure |
| Posted By DeCarli Law |
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Mallinkrodt Inc., the manufacturer of gadolinium-based contrast agent OptiMARK, announced yesterday that it has submitted a label change that warns against any use of OptiMARK on patients with severe renal impairment due to the risk of Nephrogenic Systemic Fibrosis (NSF). OptiMARK’s revised label contraindicates the product’s use in patients with acute or chronic severe renal insufficiency (kidney failure), as well as patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplant period.
This is a major change from OptiMARK’s prior warning, which was significantly weaker. The prior warning, which all other gadolinium-based contrast agents sold in the United States also have, only cautions against use of OptiMARK on patients with severe renal failure. It says that OptiMARK and the other gadolinium-based contrast agents can properly be used if “the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI).” The new label will warn against any use of OptiMARK on patients with kidney failure.
Although OptiMARK’s maufacturer describes this label change as voluntary, there is likely more going on behind the scenes. On December 8, 2009, the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee will meet to review the current warnings required for gadolinium-based contrast agents. It may be that Mallinckrodt was worried the FDA would order a warning change, so it decided to make the change itself in order to claim the move was voluntary.
This label change is important for the ongoing MRI side effect lawsuits brought by people suffering from Nephrogenic Systemic Fibrosis (NSF), especially for people who contracted NSF after using the GE product Omniscan. OptiMARK’s chemical structure is similar to the structure of Omniscan. Both have a linear structure, which may contribute to why OptiMARK and Omniscan have an approximately 30% lower thermodynamic stability than their competitors Magnevist, Multihance, and Prohance. Also, a disproportionately greater number of people have developed NSF after use of Omniscan and OptiMARK relative to the market share of these products. It will be interesting if GE makes a similar label change for Omniscan -- or if the FDA orders GE to do so.
Nephrogenic Systemic Fibrosis (NSF) is a debilitating and sometimes fatal disease characterized by the hardening of the skin, muscle and internal organs. If you or a loved one developed NSF after treatment with a gadolinium-based contrast agent during an MRI or other medical scan, contact the MRI side effect lawyers/NSF attorneys at DeCarli Law for a free consultation to learn about your legal options.
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