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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 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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| 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 21, 2009 |
| FDA Considered Recommending that GE Gadolinium Contrast Agent Omniscan Never Be Used on Patients with Renal Failure |
| Posted By DeCarli Law |
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In May 2007, the FDA ordered all manufacturers of gadolinium-based contrast agents to warn of the risk of Nephrogenic Systemic Fibrosis (NSF) for people with kidney disease. However, the FDA considered specifically targeting General Electric product Omniscan and recommending that it never be used on people with kidney failure.
The current warning required for gadolinium-based contrast agents applies to all brands of gadolinium-based contrast agents. The warning does not state that gadolinium-based contrast agents should never be used for patients with renal failure, just that they only should be used if the diagnostic benefits outweigh the risk of developing NSF.
However, one FDA staff member recommended more. In a recently released FDA document, FDA staff member Dr. Louis Marzella stated that “a contraindication for Omniscan is warranted in patients with severe renal insufficiency.” The term “contraindication” means a recommendation against using a specific medical treatment under certain circumstances.
In the United States, GE’s product Omniscan has an approximately 30% market share of gadolinium-based contrast agents. Bayer HealthCare’s product, Magnevist, is the market leader, with a 50% market share. But despite Omniscan’s smaller market share, in the data reviewed by the FDA in 2007, there were nearly twice as many incidents of NSF among people treated with Omniscan as there were for people treated with Magnevist.
A recent ProPublica article details how the FDA decided not to single out Omniscan, and also discusses strong-arm tactics used by GE to force hospitals to use their product instead of safer alternatives. See Jeff Gerth, “Specter of MRI Disease Haunts GE,” ProPublica, Oct. 15, 2009.
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| October 07, 2009 |
| Mayo Clinic Study Ignores Risk of Nephrogenic Systemic Fibrosis (NSF) From Gadolinium-Based Contrast Agents |
| Posted By DeCarli Law |
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The optimistic sounding conclusion of a recent study on the safety of gadolinium-based contrast agents is misleading to the extent it fails to address the risk of Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD). The study, published by members of the Department of Radiology at the Mayo Clinic, concludes that “gadolinium contrast agents are associated with a very low rate of adverse effects.” Hunt, et al., Frequency and Severity of Adverse Effects of Iodinated and Gadolinium Contrast Materials: Retrospective Review of 456,930 Doses, AJR: 193, October 2009.
This conclusion masks the fact that occurrences of NSF were not counted as part of the study. Incidents of NSF were not counted because the study defined “adverse effects” to only include side effects that occurred during or immediately after administration of the gadolinium-based contrast agent.
The study reports that of 158,439 doses of gadolinium contrast agents between 2002 and 2006, there were only 64 “cases of adverse effects” for gadolinium. But the devil is in the details, in this case the study’s definition of “adverse effect”: “Adverse effect was defined as a reaction occurring in the radiology suite during contrast administration or within 30 minutes of administration.” (Emphasis added)
This definition means that cases of NFS were not even considered in the study. Why? Because the symptoms of NSF appear later than 30 minutes after the administration of the gadolinium-based contrast agent. Generally, NSF symptoms appear between several days and several months after injection of a gadolinium-based contrast agent. Indeed, symptoms have been documented as appearing as long as 18 months later.
Even the cause of NSF does not occur within 30 minutes after administration of the gadolinium-based contrast agent. This is because for a person with normal functioning kidneys, the contrast agent flushes out in approximately 90 minutes. On the other hand, the people who contract NSF are those who still have the contrast agent in their system several hours later, when the gadolinium-based contrast agent begins breaking down. It is only at this point, well after the 30 minute post-administration period considered in the study, that the toxic gadolinium is dispersed throughout the body.
So if someone tells you gadolinium-based contrast agents are safe based on this Mayo Clinic study, you are now warned of the weak basis for such a claim. The study, by its own terms, did not address incidents of Nephrogenic Systemic Fibrosis (NSF) and other serious long-term side effects related to gadolinium-based contrast agents.
To learn more about Nephrogenic Systemic Fibrosis (NSF), and your legal rights if you have contracted this disease, click HERE. You also may contact the MRI lawyers (gadolinium lawyers) at DeCarli Law for a free, no-obligation consultation.
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| Continue reading "Mayo Clinic Study Ignores Risk of Nephrogenic Systemic Fibrosis (NSF) From Gadolinium-Based Contrast Agents" » |
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| October 01, 2009 |
| The Term "MRI Lawsuit" is Misleading |
| Posted By Bob DeCarli |
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An internet search for the phrase “MRI lawsuit” will pull up various law-firm and attorney-sponsored websites. The term “MRI lawsuit,” however, is misleading. Magnetic resonance imaging (MRI) itself does not cause nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD).
The real culprits are gadolinium-based contrast agents. An injection of a gadolinium-based contrast agent -- even just one -- can cause NSF/NFD. These contrast agents are used in some, but not all, MRIs. If nothing was injected into you for your MRI, you did not receive a gadolinium-based contrast agent and therefore are not at risk of developing NSF. Further, gadolinium-based contrast agents are also used in medical scans other than MRIs, despite the fact that the FDA has not approved their use in these treatments. These unapproved uses include the following: MRA, angiogram/angioplasty, CT scan (CAT scan), fistulogram, and venogram.
So you cannot bring a lawsuit merely because you had an MRI. You may, however, have a strong legal claim if you have developed nephrogenic systemic fibrosis (NSF) after receiving an injection of a gadolinium-based contrast agent for an MRI or other medical scan. No matter what you call them -- MRI lawsuits, NSF lawsuits, or gadolinium lawsuits -- the attorneys at DeCarli Law can handle them. Call for a free consultation.
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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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