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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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| May 10, 2010 |
| Federal Judge Rejects GE Healthcare Arguments to Exclude Expert Testimony on Cause of NSF |
| Posted By DeCarli Law |
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A recent court ruling has strengthened the legal position in federal court of those suffering from Nephrogenic Systemic Fibrosis (NSF). A federal judge rejected the arguments of defendant GE Healthcare that plaintiffs should not be allowed to present expert testimony on how GE Healthcare’s brand of gadolinium-based contrast agent, Omniscan, causes NSF.
Some NSF victims have filed their claims in federal court, and their claims have been consolidated using a procedure known as multi-district litigation (MDL). The NSF MDL is pending in the United States District Court for the Northern District of Ohio. In federal court, scientific evidence must be sufficiently reliable in order for it to be presented to a jury. General Electric Healthcare claimed that the evidence presented by NSF victims on how Omniscan causes NSF was not sufficiently reliable for the jury to hear the evidence.
The federal court rejected GE Healthcare’s argument, and ruled that evidence supporting the “free gadolinium” theory could be presented to the jury. In rejecting GE Healthcare’s request, the Court noted that GE’s own experts acknowledge that it is “the prevailing theory in the scientific community.” To read the entire order, go HERE
. To learn more about how Omniscan and other gadolinium-based contrast agents cause NSF, go HERE
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Nephrogenic Systemic Fibrosis (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 are the gadolinium-based contrast agents used in a medical procedure such as an MRI, MRA, angiogram/angioplasty, and CT scan (CAT scan), among others. Diabetics and others with severe kidney impairment are most at risk of developing NSF. The attorneys at DeCarli Law are familiar with NSF, and help people who suffer from NSF assert their legal rights. If you believe you or a loved has NSF, feel free to contact the gadolinium lawyers at DeCarli Law for a free, no-obligation telephone consultation.
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| January 08, 2010 |
| Dialysis or Kidney Transplant After Colonoscopy |
| Posted By DeCarli Law |
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If you began having serious kidney problems just weeks after a colonoscopy, the cause may have been the Fleet Phospho-Soda or Fleet Phospho soda EZ Prep Bowel Cleansing System you used before your colonoscopy.
Fleet Phospho-Soda and Fleet Phospho soda EZ Prep Bowel Cleansing System were over-the-counter products recommended to cleanse the bowels before a colonoscopy. They are a type of oral sodium phosphate or “OSP.” The FDA issued a safety alert on December 11, 2008, warning that OSPs can cause kidney failure (renal failure), and the Fleet products were recalled from the market. Side effects include dialysis and the need for a kidney transplant.
If you or a loved one used one of these products before a colonoscopy, and are now on dialysis or were forced to have a kidney transplant, you may have a strong legal claim. Contact the attorneys at DeCarli Law for a free, no obligation consultation. As is often the case with legal claims, a short deadline may apply to your claim, so please contact us as soon as possible if you believe you were injured by Fleet Phospho-Soda or Fleet Phospho soda EZ Prep Bowel Cleansing System.
UPDATE: As of August 1, 2010, DeCarli Law is no longer accepting new cases for people injured by Fleet Phospho-Soda or Fleet Phospho soda EZ Prep Bowel Cleansing System.
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| January 06, 2010 |
| Gadolinium-Based Contrast Agents Speed Multiple Myeloma Cell Growth |
| Posted By DeCarli Law |
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A paper presented at the recent annual convention of the American Society of Hematology reported that exposure to the gadolinium-based contrast agent Omniscan, manufactured by GE Healthcare, speeds the growth of multiple myeloma cells.
Multiple myeloma is a cancer of the white blood cells. MRIs enhanced with gadolinium-based contrast agents are frequently used to image bone marrow, where white blood cells are produced. The researchers found that multiple myeloma cell growth rates were 8-20 times greater after exposure to Ominiscan, depending on the size and frequency of Omniscan exposure.
Significantly, autopsies of eight multiple myeloma patients who had repeated exposures to Omniscan revealed “massive quantities of gadolinium accumulation in tissues” regardless of renal function. This is particularly troubling. The current understanding is that people with impaired renal function are at the greatest risk of the gadolinium ion breaking free from the contrast agent and depositing in their bodies because their kidneys are unable to remove the agent from their bodies before it begins breaking down. These findings indicate that large amounts of gadolinium can be deposited in the body even if a person’s kidneys are functioning normally.
Gadolinium is a rare earth element long known to be toxic to human tissue. Gadolinium-based contrast agents, used for medical scans such as MRI and MRA, cause Nephrogenic Systemic Fibrosis (“NSF”). NSF is a progressive, incurable disease characterized by hardening of the skin and other body tissues. Dialysis patients are most at risk of developing NSF. If you or someone you know has NSF, you may have a legal claim against the manufacturer of the gadolinium-based contrast agent that caused the disease. Contract the NSF lawyers/MRI attorneys at DeCarli Law for a free consultation. |
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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 04, 2009 |
| UV-A1 Therapy Promising for Nephrogenic Systemic Fibrosis (NSF) |
| Posted By DeCarli Law |
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A recent study indicates that UV-A1 phototherapy has promise for reducing symptoms of Nephrogenic Systemic Fibrosis (NSF). Four patients with NSF were treated with UV-A1. The skin on all four softened, and for two, their hand and leg mobility improved.
The study was conducted by the Dermatology Department of the University of Texas Southwestern Medical Center, in Dallas. All four patients had NSF and were undergoing hemodialysis. They were treated with a UV-A1 bed with varying levels of radiation depending on their complexion. UVA radiation has a long wavelength that enables it to reach the subcutis (the connective tissue beneath the skin).
After treatment, the effected areas of the skin on all four of the patients became less hard, and had decreased pain and itching. Two had increased joint mobility, resulting in an enhanced quality of life. Significantly, their improvements appeared to last. The patients were tracked for varying lengths of time after treatment (six months to one year), and their improved skin condition and mobility lasted during those periods. This is very promising, since the improvements from other experimental treatments appear far more temporary.
You may obtain a complete copy of this study HERE. Tran, et al., “UV-A1 Therapy for Nephrogenic Systemic Fibrosis,” Archives of Dermatology, Vol. 145, No. 10, Oct. 2009, pp. 1170-1182.
Nephrogenic systemic fibrosis (NSF) is a disease characterized by hardening of the skin and other tissue caused by exposure to a gadolinium-based contrast agent. Dialysis patients and others with renal failure (kidney failure) are at greatest risk for this MRI side effect. If you have been diagnosed with NSF or are experiencing symptoms of NSF (hardening of the skin, joint pain), you may have a legal claim against the manufacturer of the contrast agent used in your treatment. Contact the MRI lawyers/NSF attorneys at DeCarli Law for a free consultation.
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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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| September 28, 2009 |
| Lower Leg Skin Symptoms Can Distinguish Nephrogenic Systemic Fibrosis (NSF) From Other Fibrosing Disorders |
| Posted By DeCarli Law |
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Nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD), can be difficult to distinguish from other fibrosing skin disorders. However, according to a recent study, a prevalence of skin symptoms on the lower legs, at least in late stages of the disease, can set NSF/NFD apart.
A Danish study looked at 17 patients with NSF late in the disease. All but one of them had skin symptoms of various sorts, and all of those had skin symptoms on their lower legs. Six had symptoms only on their lower legs, while 3 others had symptoms on both their lower legs and thighs. The remaining 7 had skin symptoms on their arms or fingers in addition to their lower legs. Additionally, all 16 had some loss of hair on the affected areas of their skin.
The study observed that the prevalence of skin symptoms on the lower legs tends to distinguish NSF/NFD from other disorders that involve fibrosing of the skin, such as scleromyxedema and morphea/scleroderma. Morphea/scleroderma usually begins on the trunk and then spreads to all limbs. Scleromyxedema usually involves the head and neck, which was not the case for any of the participants in the Danish study. The entire article reporting the results of this study was reprinted in the February 2009 issue of Archives of Dermatology, an American Medical Association publication, and may be obtained HERE.
While this study indicates a prevalence of skin symptoms on the lower legs, it is important to note that the participants in the study all had late stages of NSF. Skin symptoms have been known to appear first on the hands, wrists and forearms rather than on the lower legs. Skin symptoms include swelling, thickening and tightening of the skin. The skin often feels hard, "woody" or "leathery," and can have an orange peel consistency.
The only people who have contracted NSF/NFD are those who have been injected with a gadolinium-based contrast agent in conjunction with an MRI or other medical scan. Those most at risk are dialysis patients, and patients with partial or total renal (kidney) failure, liver disease, diabetes, or high blood pressure.
If you have NSF/NFD, you may have a legal claim against the manufacturer of the gadolinium-based contrast agent that caused your injury. You may contact DeCarli Law for a free consultation to learn more about your rights and options. You also can learn more about gadolinium-based contrast agents HERE, and about nephrogenic systemic fibrosis (NSF) HERE.
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| September 22, 2009 |
| Nephrogenic Systemic Fibrosis: A Frequently Undiagnosed and Misdiagnosed Disease |
| Posted By Bob DeCarli |
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Because nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD), is a new disease, it is often misdiagnosed or goes undiagnosed. Even worse, dialysis patients and others with impaired kidney function -- those most at risk of developing NSF -- are still receiving MRIs with gadolinium-based contrast agents.
Debra DeCarli was interviewed about this problem for a recent article:
“A lot of people are unaware of this disease,” says DeCarli. “As well, many doctors don't recognize it and don't do a biopsy that is necessary to make the diagnosis.” However, DeCarli says there has been an increase in the last 18 months on continuing education programs for the medical community that addresses NSF. Still, she believes NSF is a widely underreported disease for several reasons.
“People on dialysis have problems anyway and people who get MRIs already have health issues,” DeCarli explains. “As well, I am finding that a lot of people in their 40s or 50s who see a doctor for leathery skin and joint pain [classic symptoms of NSF] and the doctor attributes their problems to simply growing old. Quite often, they are misdiagnosed with rheumatism or arthritis: in fact, one of the foremost NSF experts in the country is a rheumatologist.”
You can read the complete article here. You may also read more about NSF on our website.
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