Yourlawyer.com (NSF News)

Dialysis, Kidney Transplant Patients Face Higher Risk of NSF from Gadolinium Agents

Fri, 20 Nov 2009 00:00:00 -0800

A study of patients exposed to gadolinium contrast dyes at the Mayo Clinic has revealed that hemodialysis patients had a 77-fold higher risk of developing nephrogenic systemic fibrosis (NSF), while kidney transplant patients had a 69-fold higher risk of the disease. The NSF study was published in the October issue of the Archives of Dermatology.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. There are currently five such agents sold in the U.S.: Covidien's OptiMARK; Prohance and Multihance, both by Bracco Diagnostics; Bayer Healthcare’s Magnevist; and GE Healthcare’s Omniscan.

It appears that NSF only develops in people with pre-existing kidney disease who are exposed to the gadolinium agents. In September 2007, the U.S. Food & Drug Administration (FDA) asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.

The Mayo Clinic study involved 94,917 patients exposed to gadolinium agents at the Mayo Clinic between January 1, 1999 and December 31, 2006. Of that group, 3,779 patients were on hemodialysis, 1,694 patients had undergone a kidney transplant, and 717 patients had liver transplants. A total of 61 patients had a clinical diagnosis of NSF.

The study found that 1% of patients undergoing hemodialysis, and 0.8% of patients who have undergone kidney transplant were at risk of developing NSF. The risk for liver transplant patients was 0%.

The study authors advocated for the development of new guidelines for the administration of gadolinium agents.

We reported previously this week that the FDA is still looking into the association between gadolinium agents and NSF. On Wednesday, we reported that an FDA review had found that OptiMARK, Magnevist and Omniscan carried a higher risk of NSF than other gadolinium agents on the market. Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

Following the news from the FDA, Covidien announced it would be modifying the label on OptiMARK to contraindicate its use in patients with severe kidney impairment. Mallinckrodt Inc., a Covidien company, has submitted this label change to the FDA and says it is implementing the new label in the U.S. effective immediately. Covidien also will update its educational materials to help physicians make informed decisions regarding the appropriate use of OptiMARK.

OptiMARK Gadolinium Contrast Agent Label Changed Over NSF Risk

Thu, 19 Nov 2009 00:00:00 -0800

The maker of OptiMARK gadolinium contrast agent is modifying the product's label to contraindicate its use in patients with severe kidney impairment because of its association with nephrogenic systemic fibrosis (NSF). Mallinckrodt Inc., a Covidien company, has submitted this label change to the U.S. Food and Drug Administration (FDA) and says it is implementing the new label in the U.S. effective immediately.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition OptiMARK, other agents on the market include Prohance and Multihance, both by Bracco Diagnostics, Bayer Healthcare's Magnevist and GE Healthcare's Omniscan.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

It appears that NSF only develops in people with pre-existing kidney disease. In September 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.

Yesterday, we reported that an FDA review had found that OptiMARK, Magnevist and Omniscan carried a higher risk of NSF than other gadolinium agents on the market. Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

In a statement released by Covidien yesterday, the company said it is implementing its OptiMARK label change in all countries where OptiMARK contrast agent has been approved for sale, in accordance with local regulatory requirements. Covidien also will update its educational materials to help physicians make informed decisions regarding the appropriate use of OptiMARK

“For the small percentage of the U.S. population – less than 0.5 percent – with severe renal impairment, we believe it is prudent to act now, rather than wait for a causal link between GBCAs (gadolinium based contrast agents) and NSF to be established. Although the label already advises caution when using GBCAs with these patients, we are voluntarily taking this next step to help ensure this small, at-risk population does not receive administration of a contrast agent that could pose a risk of NSF.” said Dr. Herbert Neuman, Vice President, Medical Affairs and Chief Medical Officer, Pharmaceuticals, Covidien.

Magnevist, Omniscan and OptiMARK Have Highest Risk of NSF, FDA Says

Wed, 18 Nov 2009 00:00:00 -0800

Three gadolinium contrast dyes - Bayer Healthcare's Magnevist, GE Healthcare's Omniscan, and Covidien 's OptiMARK -carry a higher risk of nephrogenic systemic fibrosis (NSF) than other agents on the market, according to the U.S. Food & Drug Administration (FDA). Though the agency's drug safety unit said the risk associated with the gadolinium contrast dyes "does not compel removal of specific (imaging agents) from the U.S. market", it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition to Omniscan, Magnevist and OptiMARK, other agents on the market include Prohance and Multihance, both by Bracco Diagnotics.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. NSF is a relatively new disease. In fact, the first known diagnosis of NSF only occurred in 1997, but it wasn’t until September 2000 that details of the disease were published in the medical journal Lancet.

It appears that NSF only develops in people with pre-existing kidney disease. In 2006, Dutch researchers were the first to link NSF with the use of gadolinium contrast dyes. In September 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.

According to documents released yesterday by the FDA, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMARK. The lowest risk was associated with Prohance and Multihance. However, the agency said "the data do not appear to rule out an NSF risk for each of the agents." FDA reviewers said the extent of risk from any of the agents was unknown. One study of Omniscan estimated the chances of developing NSF was 4 percent among patients with severe kidney impairment.

According to a Reuters report, Covidien has already decided to modify the labeling of OptiMARK. A spokesperson for the company told Reuters that "it was prudent to act now, rather than wait for a causal link... to be established" between the imaging drugs and NSF.

Study Suggests "Potent" Link Between NSF, Gadolinium Contrast Dyes

Fri, 03 Apr 2009 00:00:00 -0700

Another study has found a strong link between the use of gadolinium contrast dyes and the development of Nephrogenic Systemic Fibrosis (NSF). According to researchers at the University of Pennsylvania in Philadelphia, patients with advanced chronic kidney disease were 27 percent more likely to develop NSF if they were exposed to a gadolinium contrast dye than those who were not.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. These dyes include: Omniscan by GE Healthcare; OptiMARK by Mallinckrodt/Tyco Healthcare; Magnevist by Bayer/Schering AG/Berlex; ProHance by Bracco Diagnostics and MultiHance by Bracco Diagnostics.

In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the products' labels regarding their association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

NSF is a relatively new disease. In fact, the first known diagnosis of NSF only occurred in 1997, but it wasn't until September 2000 that details of the disease were published in the medical journal Lancet. It appears that it only develops in people with pre-existing kidney disease.

Several studies have strongly suggested a link between NSF and gadolinium contrast dyes. This latest study, published in the journal Nephrology Dialysis Transplantation, consisted of a systemic review and meta-analysis of seven controlled studies that have examined the association between gadolinium contrast dyes and NSF.

The meta-analysis found very strong evidence of a causal relationship between NSF and gadolinium contrast dyes. According to a press release detailing the University of Pennsylvania study, that evidence included:

consistently similar results and large magnitude of effect shown in all studies analyzed;
a clear temporal relationship found in all but one study;
a dose-response relationship shown in three studies. Two studies did not find this relationship and the other studies did not examine the relationship.

In addition, gadodiamide is excreted renally, so it is biologically plausible for it to cause NSF, the investigators observed. Furthermore, gadodiamide is both detectable and quantifiable in the tissues of patients with NSF. Finally, the researchers cited a case in which a patient who had clinical resolution of NSF developed the condition again when re-exposed to a gadolinium contrast dye.

The authors of the met-analysis concluded that their findings suggest a "potent and significant" association between gadolinium contrast dyes and NSF among patients with advanced chronic kidney disease.

Gadolinium Contrast Dye Lawsuit Trials Will Start in January

Wed, 25 Mar 2009 00:00:00 -0700

The first civil trials involving gadolinium MRI contrast dyes are scheduled to begin early next year. Hundreds of lawsuits have been filed against the makers of gadolinium MRI contrast dyes by people who claim the agents caused them or a loved one to develop Nephrogenic Systemic Fibrosis (NSF). Gadolinium dye makers Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt have all been named as defendants in the cases.

In February 2008, the U. S. Judicial Panel on Multidistrict Litigation designated the U.S. District Court for the Northern District of Ohio as the venue for NSF lawsuits pending in federal courts. The Judicial Panel on Multidistrict Litigation of the United States Courts was created in 1968. Since then, it has consolidated hundreds of thousands of lawsuits that involved high numbers of plaintiffs, including litigation over asbestos, breast implants and other matters.

Currently, there are just over 400 lawsuits pending in the Multidistrict Litigation. At a status conference held on March 6, Judge Dan Aaron Polster announced that the first trials will begin next January. The parties involved in the litigation have each selected 10 cases, known as Eligible Trial Pool Cases, which are currently undergoing early discovery in preparation for the first trials. Those 20 will be narrowed down to 10, with 5 chosen by the plaintiffs and 5 chosen by the defendants for the first trials. Defendants and plaintiffs will then select two from each sides' list for the first four trials.

NSF is a devastating condition that affects people with pre-existing kidney problems. There is currently no cure for NSF and no one understands its specific cause. The disorder is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

A growing mountain of evidence has linked NSF to gadolinium contrast dyes, and it is theorized that people with kidney problems may not be able to quickly eliminate gadolinium from their body. In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents if they must undergo an MRI or MRA procedure.

Gadolinium Contrast Dye Risks Can be Reduced Through Screening

Thu, 05 Feb 2009 00:00:00 -0800

A new study has found that clinicians can reduce the chances that kidney patients exposed to gadolinium contrast dyes will develop Nephrogenic Systemic Fibrosis (NSF) if they screen patients for risk factors of the disease. The study, which was conducted at the Johns Hopkins University School of Medicine in Baltimore, found that the implementation of policies regarding the use of gadolinium contrast dyes in patients with severe renal dysfunction resulted in reducing the incidence of NSF.

NSF is a devastating condition that affects people with pre-existing kidney problems. There is currently no cure for NSF and no one understands its specific cause. The disorder is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

A growing mountain of evidence has linked NSF to gadolinium contrast dyes used in MRI and MRA studies, and it is theorized that people with kidney problems may not be able to quickly eliminate gadolinium from their body. In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents. Since then, hundreds of NSF victims and their families have filed lawsuits in state and federal courts against the makers of gadolinium contrast dyes for their injuries.

The Johns Hopkins study, which is published in the February issue of the journal Radiology, involved 33 patients diagnosed with NSF from 2003 to 2008. All had previously undergone MRI or an angiographic procedure using a gadolinium contrast dye, and all had severe kidney failure at the time of exposure.

According to the study, the mean time between gadolinium injection and onset of the disease was 29 days. Between 2003 and 2006, the overall incidence of NSF was 36.5 cases per 100,000 gadolinium-enhanced MRI procedures.

After the FDA issued its 2006 gadolinium warning, Johns Hopkins implemented new policies regarding the administration of the contrast dyes in patients with kidney failure. According to the researchers, the rate of NSF fell in 2007 and 2008 to four cases per 100,000 procedures.

The researchers concluded that common risk factors for developing NSF after gadolinium exposure were acute and severe chronic kidney failure and liver or kidney transplantation. The also found that screening procedures performed before exposure to gadolinium to determine which patients were at risk of developing NSF appear to reduce the incidence of NSF. Finally, the study authors wrote that their findings further support the belief that NSF is associated with the administration of gadolinium contrast dyes.

Vasovist Approved for MRA Procedures

Mon, 29 Dec 2008 00:00:00 -0800

Federal health regulators have approved a new gadolinium contrast agent for use in magnetic resonance angiography, or MRA. The Food & Drug Administration (FDA) chose to approve Epix Pharmaceutical's Vasovist Injection despite the known association between gadolinium contrast dyes and a disorder called Nephrogenic Systemic Fibrosis (NSF). The FDA said a boxed warning about the risk of NSF will be included on the labeling of Vasovist.

Vasovist is the first contrast imaging agent for use in patients undergoing MRA, a minimally invasive test for examining blood vessels. Although MRA can be performed without the use of a contrast imaging agent, the FDA said Vasovist administration provides a clearer image in patients who are suspected of having blockages or other problems with the blood vessels in their abdomen or limbs. The MRA is performed using magnetic resonance imaging (MRI), which relies on magnetic fields to create highly detailed images of the inside the body.

When blood vessels are scanned using MRA without any contrast, radiologists are unable to interpret the images about 10 percent to 30 percent of the time, the FDA said. As a result, radiologists have typically used X-rays to detect blood vessel abnormalities. But this is a lengthy procedure and requires sticking a needle into an artery to inject the X-ray dye, a procedure that may result in injury to vessel walls, blood clots, allergic reactions and potential kidney damage. According to the FDA, Vasovist is injected into a peripheral vein and no artery is punctured, thus the potential risks are fewer.

However, like any gadolinium agent, Vasovist can expose people with pre-existing kidney disease to the risk of NSF. This disease first presents as a skin condition, and often patients and their doctors don't even realize they are dealing with something extremely serious. In most people the legs are affected first, then the feet, arms and hands. In some NSF patients the trunk of the body is also affected. NSF leads to excessive formation of connective tissue in the skin and internal organs. This disease can progress to the point of causing severe stiffness in joints, and it can lead to death.

NSF has only been seen in people with pre-existing kidney disease who have been exposed to gadolinium contrast dyes. Since 2006, the FDA has issued three separate warnings about gadolinium contrast agents and their link to NSF. The agency has also required the makers of the dyes to include a black box warning on their products' labels. The same warning will also appear on Vasovist.

Prior to the approval of Vasovist, other gadolinium contrast agents were sometimes used off-label in MRA procedures. For those gadolinium contrast dyes to be effective in an MRA, they had to be administered at three times the approved dose. If a person’s kidneys are not functioning properly, it is extremely unlikely that so much gadolinium will be eliminated from the body. That made it far more likely that a patient with pre-existing kidney disease would develop NSF if exposed to one of these agents in an MRA procedure. In fact, some of the first reports of NSF actually occurred in patients who were exposed to gadolinium during MRA.

Another Study Links NSF to Gadolinium Contrast Dyes

Tue, 14 Oct 2008 00:00:00 -0700

A new study of people with Nephrogenic Systemic Fibrosis (NSF) has again found a strong link between the condition and the use of gadolinium contrast dyes. The study, conducted by researchers at Vanderbilt University, concludes that gadolinium contrast dyes should be used "judiciously" in patients with pre-existing kidney disease, and their benefits should be carefully weighed against their risks.

NSF is a devastating condition that affects people with pre-existing kidney problems. There is currently no cure for NSF and no one understands its specific cause. The disorder is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

A growing mountain of evidence has linked NSF to gadolinium contrast dyes used in MRI and MRA studies, and it is theorized that people with kidney problems may not be able to quickly eliminate gadolinium from their body. In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents.

Since then, hundreds of NSF victims and their families have filed lawsuits in state and federal courts against the makers of gadolinium contrast dyes for their injuries. As of September 24, there were 287 NSF lawsuits pending in the Multidistrict Litigation. Another 104 lawsuits have been filed in various state courts throughout the U.S. Gadolinium dye makers Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt have all been named as defendants in the cases.

For their study, researchers at Vanderbilt analyzed data from case series reports, NSF patient databases, NSF case reports submitted to the FDA after gadolinium contrast agent exposure and retrospective case control studies. According to the study abstract, there was a strong association between the use of gadolinium contrast dyes used in MRI procedures, and the subsequent development of NSF in patients with kidney disease.

The study abstract said that occurrence of NSF after gadolinium contrast agent exposure varied from negligible up to 2% to 5% in select high risk clinical situations. The study also found that the risk of NSF depends on the degree of renal dysfunction, dose of contrast agent, gadolinium contrast agent stability and severity a patient's kidney disease.

NSF Lawsuits Moving Ahead in Multidistrict Litigation

Wed, 01 Oct 2008 00:00:00 -0700

Lawsuits filed by people claiming that gadolinium contrast agents caused them to develop Nephrogenic Systemic Fibrosis (NSF) are moving forward in the Multidistrict Litigation in the U.S. District Court for the Northern District of Ohio. Last week, the judge overseeing the litigation established a series of ground rules for the consolidated discovery phase of hundreds of cases.

NSF is a devastating condition that affects people with pre-existing kidney problems. There is currently no cure for NSF and no one understands its specific cause. The disorder is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

A growing mountain of evidence has linked NSF to gadolinium contrast dyes, and it is theorized that people with kidney problems may not be able to quickly eliminate gadolinium from their body. Dutch scientists made the first connection between NSF and gadolinium in 2006. Researchers at Yale University have reported that 95-percent of those with NSF had undergone a Magnetic Imaging Resonance (MRI) procedure that involved a gadolinium contrast dye two to three months before their symptoms appeared. Since then, several other studies have made similar connections. Another study at Massachusetts General Hospital also found that kidney patients who had undergone MRIs with gadolinium contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents.

Since then, hundreds of NSF victims and their families have filed lawsuits in state and federal against the makers of gadolinium contrast dyes for their injuries. In February 2008, the U. S. Judicial Panel on Multidistrict Litigation designated the U.S. District Court for the Northern District of Ohio as the venue for NSF lawsuits pending in federal courts. The Judicial Panel on Multidistrict Litigation of the United States Courts was created in 1968. Since then, it has consolidated hundreds of thousands of lawsuits that involved high numbers of plaintiffs, including litigation over asbestos, breast implants and other matters.

Multidistrict Litigation is not the same as a class action lawsuit. Each case in a Multidistrict Litigation retains its own identity. If the Multidistrict Litigation process does not resolve the cases, they are transferred back to the court where they originated for trial.

As of September 24, there were 287 NSF lawsuits pending in the Multidistrict Litigation. Another 104 lawsuits have been filed in various state courts throughout the U.S. Gadolinium dye makers Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt have all been named as defendants in the cases.

For the next Multidistrict Litigation conference, lawyers must provide product identification in approximately 75% of the cases where a plaintiff fact sheet has been exchanged prior to October 1 before the case can be designated for an early trial pool. Attorneys for both sides must also choose 10 cases each by November to undergo discovery. The 20 cases will be reduced to 10 by May 2009 for the court to begin case-specific expert discovery. By January 23, plaintiffs must also submit expert reports limited to any generic experts they may call in the initial trials.

Hemodialysis After MRI with Gadolinium Could Prevent NSF in Some Kidney Patients

Thu, 21 Aug 2008 00:00:00 -0700

A new study indicates that some kidney patients who undergo hemodialysis following exposure to gadolinium contrast dyes during an MRI may be at less risk of developing nephrogenic systemic fibrosis (NSF). The study, conducted by researchers at Weill Medical College of Cornell University and Columbia University's College of Physicians and Surgeons in New York, was recently published in the journal "Radiology".

NSF is debilitating, and sometimes fatal disease, that affects people with pre-existing kidney diseases who have undergone MRI studies that involve gadolinium contrast dyes. There is currently no cure for NSF and no one understands its specific cause. The disorder is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

The evidence that gadolinium contrast agents play a role in the development of NSF is fast becoming irrefutable. Dutch scientists made the first connection between NSF and gadolinium in 2006. Since then, researchers at Yale University have reported that 95-percent of those with NSF had undergone a Magnetic Imaging Resonance (MRI) procedure that involved a gadolinium contrast dye two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with gadolinium contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

In 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents.

For the study detailed in Radiology, researcher analyzed cases of biopsy-confirmed NSF among all patients who received a gadolinium-based contrast agent between January 1, 1997, and June 30, 2007. In total, there were 31 biopsy-confirmed cases of NSF in 10 men and 21 women. The patients ranged in age from 13 to 82 years.

The researchers found that hemodialysis helped prevent NSF in patients with an estimated glomerular filtration rate (eGFR)- a measure of kidney function - of less than 15 mL/min. Increased risk of NSF was associated with patients with an eGFR of less than 30 mL/min who received a higher dose of gadolinium contrast dye, and who also experienced acute renal failure, delayed hemodialysis after contrast agent injection, proinflammatory events, and hyperphosphatemia, a condition where there is abnormally elevated level of phosphate in the blood.

The study also found that the dosage level of the gadolinium agent played a role in the development of NSF. The occurrence NSF after gadolinium-based contrast agent administration without screening for renal function were 0 of 74,124 patients with a standard gadolinium dose and 15 (0.17%) of 8,997 patients with the high dose. The incidence associated with the high dose increased to 0.4% in the patients who received hemodialysis and increased to 8.8% in patients who had an eGFR less than 15 mL/min but had not received hemodialysis treatment.

Eleven of 69 patients with acute renal failure who received a high dose when their creatinine level was increasing developed NSF when hemodialysis was delayed for more than two days.

The authors of the study concluded that the chances of a patient developing NSF could be lessened by first identifying those with eGFR in the range of 30 mL/min or less. Those patients should receive a lower dose (no more than 0.1 mmol/kg). Finally, the authors wrote that patients "who have acute renal failure with increasing serum creatinine levels or who are in a dialysis regimen at the time of gadolinium-based contrast agent administration should undergo hemodialysis shortly after the gadolinium-enhanced MR examination."

After 2 Years, NSF Sufferer Wins Fight with Insurer

Thu, 17 Jul 2008 00:00:00 -0700

A Tennesee woman with Nephrogenic Systemic Fibrosis (NSF) has won a battle with her insurance company. After two years of litigation, a judge has ordered TennCare to pay for a treatment that might save her life. TennCare is Tennessee’s Medicaid managed care program that provides health coverage for low-income children, pregnant women and disabled Tennesseans. TennCare had previously refused to cover the treatment - known as extracorporeal photopheresis - for Jeanie Deason because it was considered experimental.

NSF is a devastating condition that affects people with pre-existing kidney problems who have been exposed to gadolinium contrast dyes that are used in MRI procedures. There is currently no cure for NSF and no one understands its specific cause. The disorder is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

The evidence that gadolinium contrast agents play a role in the development of NSF is fast becoming irrefutable. Dutch scientists made the first connection between NSF and gadolinium in 2006. Since then, researchers at Yale University have reported that 95-percent of those with NSF had undergone a Magnetic Imaging Resonance (MRI) procedure that involved a gadolinium contrast dye two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with gadolinium contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

In 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents.

Deason's NSF has progressed to the point where her legs and right arm have become frozen in a bent position. During the fight with TennCare her condition deteriorated to the point where she needs someone to stay with her 24 hours a day. Now she spends her days in bed, limbs throbbing, only getting up when her parents help her go to the bathroom. She even had to miss her daughter's graduation.

The treatment that Deason hopes will restore some normalcy to her life is called extracorporeal photopheresis. It involves removing blood from a patient's body, exposing it to ultraviolet light and then re-infusing the blood into the body. It's believed that the treated blood alters the body's immune system so it can better fight the disease. It can cost around $8000 for one treatment.

Deason's physician, Dr. John Zic, an assistant professor of dermatology at Vanderbilt University who has treated four patients in this way, told the Tennessean he has seen dramatic results. One patient who was initially unable to close her hand could use a pen to sign documents after three months of treatment. Another patient had significant joint stiffness and difficulty walking. After about seven months, the patient was walking without a significant limp. In all, three of Zic's patients improved and one died because of issues with dialysis treatment, not because the treatment was ineffective

But despite the hope it holds for Deason, TennCare refused to pay or the treatment because it was experimental. Deason was forced to take the insurer to court, and in April, a judge in Davidson County Chancery Court overruled TennCare's decision, saying even though it's experimental it's medically necessary. Recently, TennCare indicated it would not fight the judge's ruling.

While Deason is pleased with the decision, she hopes it has not come too late. She hopes the treatment will eventually walk again, but she also knows her chances would have been better if she had started it two years ago.

Information: What Is Nephrogenic Systemic Fibrosis (NSF) / Nephrogenic Fibrosing Dermopathy (NFD)

Mon, 07 Apr 2008 00:00:00 -0700

Keywords: Nephrogenic Systemic Fibrosis (NSF) | Side Effects | Information | Help | Nephrogenic Fibrosing Dermopathy (NFD)

NSF (Nephrogenic Systemic Fibrosis), also known as NFD (Nephrogenic Fibrosing Dermopathy) has been linked to the use of Gadolinium MRI contrast dye in people with pre-existing kidney problems. NSF or NFD first appeared in 1997. Because of it sudden appearance, some researchers speculated that NSF or NFD resulted from exposure to a new type of toxin that people with poor kidney function could not eliminate from their blood stream. Since 2006, research has been able to directly link the use of Gadolinium MRI contrast dye in kidney patients to this serious Gadolinium side effect. The Gadolinium MRI contrast dye side effect attorneys at Parker Waichman Alonso LLP are currently evaluating Gadolinium MRI Contrast dye injury cases where victims have been afflicted with NSF and NFD.

While it only appears in patients with pre-existing kidney problems, according to The International Center for Nephrogenic Fibrosing Dermopathy Research, there is no evidence that NSF/NSD is caused by kidney disease, medications, microorganism or dialysis. But in 2006, NSF/NSD researchers made an intriguing discovery. It was at that time that researchers linked the use of gadolinium based contrast agents used in MRIs with the development of NSF/NSD. Following the 2006 discovery, the Food and Drug Administration (FDA) warned healthcare professionals that gadolinium based agents had been tied to multiple cases of NSF/NSD. Then, in 2007, the FDA went even further and requested that the manufacturers of the five gadolinium based contrast agents used in MRIs include a boxed warning on product labels highlighting the risk they posed to patients with kidney problems.

Nephrogenic Systemic Fibrosis (NSF) / Nephrogenic Fibrosing Dermopathy (NFD) Symptoms

Symptoms of NSF/NSD can appear anywhere from a few days to 18 months after a patient has been exposed to a gadolinium based contrast agent. Most patients eventually diagnosed with NSF/NSD are first found to have high blood pressure. That is followed by other symptoms, including:

Tightening and swelling of the skin
Thickening of the skin around the joints, restricting movement
Extremely hard or rough skin has the texture of an orange peel
Red or dark patches of skin
Burning, itching, and/or sharp pains in affected areas
Symmetrical skin lesions
Muscle weakness
Deep bone pain in the hips and ribs
Calcification of soft tissues
Yellow plaques near the eyes

NSF/NSD can progress to the point of causing severe stiffness in joints, and it can lead to death. The progression of the disease can be slow, and it can take several years for all of the symptoms associated with NSF/NSD to appear. However, some patients have a form of NSF/NSD that progresses so quickly that they often die of complications brought on by the disease.

Treatment for Nephrogenic Systemic Fibrosis (NSF) / Nephrogenic Fibrosing Dermopathy (NFD) Symptoms

There are no consistently successful treatments for NSF/NSD but symptoms can be improved with several methods. Physical therapy, oral steroids and some other drug therapies have shown promise in treating NSF/NSD. Improved kidney function can ease symptoms, and in some NSF/NSD patients this seems to reverse the disease overtime. Some NSF/NSD patients who have received kidney transplants have improved dramatically, but there is no guarantee that all patients will see such results.

Lawsuit Claims GE Omniscan Caused Nephrogenic Systemic Fibrosis

Thu, 06 Mar 2008 00:00:00 -0800

General Electric Company has been named in a lawsuit over its Omniscan gadolinium contrast dye. The lawsuit alleges that Omniscan caused a Philadelphia man to develop Nephrogenic Systemic Fibrosis (NSF), a debilitating and often fatal disease. The plaintiff in the Omniscan lawsuit is represented by the law firm of Parker Waichman Alonso LLP.

NSF is a devastating condition that affects people with pre-existing kidney problems. There is currently no cure for NSF and no one understands its specific cause. However, the evidence that gadolinium contrast agents play a role in its development is fast becoming irrefutable. Dutch scientists made the first connection between NSF and gadolinium in 2006. Since then, researchers at Yale University have reported that 95-percent of those with NSF had undergone a Magnetic Imaging Resonance (MRI) procedure that involved a gadolinium contrast dye two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with gadolinium contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents.

According to his lawsuit, Zbigniew Marcinczyk received two injections of Omniscan contrast dye in September and December 2005. Shortly after the administration of Omniscan, Marcinczyk developed NSF. The complaint states that Marcinczyk continues to suffer from the severe, debilitating and progressive fibrotic changes associated with NSF. NSF is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

The Omniscan lawsuit, which was filed in US District Court for the Eastern District of Pennsylvania, alleges that the chemical make-up of Omniscan makes it more likely that gadolinium will become free within the bodies of recipients, thereby making it more likely that kidney patients will develop NSF. The lawsuit further alleges that Omniscan is defective, and that the defendants, including General Electric, failed to adequately test Omniscan and failed to warn patients about its potential to cause NSF.

So far, around 68 lawsuits have been filed against the makers of gadolinium contrast dyes by victims of NSF and their families. Last month, the U. S. Judicial Panel on Multidistrict Litigation designated the U.S. District Court for the Northern District of Ohio as the venue for the many lawsuits that have been filed against the makers of gadolinium contrast dyes.

Gadolinium MRI NSF Injuries are a Risk Kidney Patients Need to Know About

Tue, 05 Feb 2008 00:00:00 -0800

Keywords: Injury | Gadolinium | Kidney | NSF | Dye | Contrast

Kidney patients need to know that MRI procedures that involve the use of gadolinium contrast dyes could put them at risk of developing Nephrogenic Systemic Fibrosis (NSF). Unfortunately, there are no alternatives for gadolinium contrast dyes available at this time, and sometime such an MRI is truly necessary. For that reason, doctors must take added precautions to lessen the chance that kidney patients undergoing MRI with gadolinium contrast dyes develop NSF

NSF is a debilitating disease that was first seen in patients in 1997, and it wasn’t mentioned in medical literature until 2000. NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

There is currently no cure for NSF and no one understands its specific cause. However, the evidence that gadolinium contrast agents play a role in its development is fast becoming irrefutable. Dutch scientists made the first connection between NSF and gadolinium in 2006. Since then, researchers at Yale University have reported that 95-percent of those with NSF had an MRI that involved a gadolinium MRI contrast dye two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with gadolinium MRI contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

The Food & Drug Administration (FDA) asked the manufactures of gadolinium contrast dyes to add a black box warning to the product labels about NSF risks in 2007. The FDA also warned that people with kidney disease should avoid gadolinium contrast agents. However, this is not always possible. If an MRI with a gadolinium contrast dye is required, the FDA has warned that the dose of the gadolinium contrast agent should not exceed that recommended in the product's label and that a repeat administration of the gadolinium contrast agent should not be performed until enough time has passed to allow for the gadolinium contrast agent from the first MRI to be eliminated from the body. The FDA recommends that patients already undergoing dialysis receive a dialysis treatment shortly following administration of a gadolinium contrast dye. Dialysis may help eliminate the gadolinium from the body, however it is not known if this will actually prevent NSF.

The FDA has also warned that the use of gadolinium contrast dyes in a procedure call Magnetic Resonance Angiography (MRA) could put kidney patients at an even greater risk of developing NSF because these procedures often use far more gadolinium than a typical MRI. The FDA has not approved the use of gadolinium contrast dyes for use in MRA.

Nephrogenic Systemic Fibrosis (NSF) Study Finds Link Between Gadolinium Used in MRI and Debilitating Disease

Thu, 31 Jan 2008 00:00:00 -0800

Keywords: NSF | Lawyer | Side Effects | Information | Nephrogenic Systemic Fibrosis | NFD | MRI | MRA

Another Nephrogenic Systemic Fibrosis (NSF) study has tied the debilitating condition to Gadolinium contrast agents used in Magnetic Resonance Imaging (MRI). This latest NSF research was conducted by the Centers for Disease Control (CDC), which examined a cluster of NSF patients at one unidentified St. Louis Missouri Hospital. The CDC found that the exposure to Gadolinium contrast dyes during MRI was independently associated with the development of NSF.

NSF (sometimes called Nephrogenic Fibrosing Dermopathy or NFD) was first seen in patients in 1997, and it wasn’t mentioned in medical literature until 2000. NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

There is currently no cure for NSF and no one understands its specific cause. However, the evidence that Gadolinium MRI contrast agents play a role in its development is fast becoming irrefutable. Researchers at Yale University have reported that 95-percent of those with NSF had an MRI that involved a Gadolinium MRI contrast dye two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with Gadolinium MRI contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

Gadolinium contrast dyes are used in MRI because they make it far easier for a diagnostician to differentiate between normal and abnormal tissue. While the tests can be done without the Gadolinium based contrast agent, they are nowhere near as effective. The FDA has warned that patients with kidney problems not be given Gadolinium based MRI contrast dyes unless it is absolutely necessary because of their association with NSF. Unfortunately, there are not yet any alternatives to gadolinium based MRI contrast agents.

The CDC study of the St. Louis NSF cases only reinforces the link between NSF and Gadolinium. According to the CDC, in May 2006, nephrologists at the St. Louis hospital reported a cluster of NFS among patients treated in their dialysis units. The CDC conducted an investigation to determine the number of affected patients and identify risk factors for NFS. Of the 19 patients eventually included in the study, only five had no identified gadolinium exposure within 1 year preceding NFS diagnosis. However, of these, four had gadolinium exposure from 16 to 68 months preceding diagnosis. Thirteen patients had multiple gadolinium-containing contrast exposures during the preceding year.

According to the CDC, the study indicated that exposure to Gadolinium-containing contrast agents during MRI studies was linked with the development of NFS. The CDC cautioned that clinicians should be aware of the potential for NFS, and when possible, should avoid use of Gadolinium-containing contrast agents in patients with advanced kidney disease.

Evidence of Gadolinium MRI Contrast Dye Link to NSF Stronger than Ever

Fri, 21 Dec 2007 00:00:00 -0800

NSF (Nephrogenic Systemic Fibrosis), sometimes called NFD (Nephrogenic Fibrosing Dermopathy) is a rare disease that so far has affected only people with pre-existing kidney problems. In 2006, researchers discovered a direct association between NSF and the use of Gadolinium MRI contrast dyes. Since that initial discovery, several other studies have reinforced the link between NSF and Gadolinium MRI contrast dyes. In 2006, the Food & Drug Administration (FDA) first warned doctors of this Gadolinium side effect. Then, in 2007 the FDA ordered the manufactures of Gadolinium contrast dyes to add a black box warning – the strictest type of FDA warning -- to their product labels advising of the risk of NSF to people with kidney problems.

NSF was first seen in patients in 1997, and it wasn’t mentioned in medical literature until 2000. NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

There is currently no cure for NSF and no one understands its specific cause. However, the evidence that Gadolinium MRI contrast agents play a role in its development is fast becoming irrefutable. Researchers at Yale University have reported that 95-percent of those with NSF had an MRI that involved a Gadolinium MRI contrast dye two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with Gadolinium MRI contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

For patients with NSF, life can become a living hell. Their skin can become so hardened that it resembles marble, while joints stiffen to the point that movement becomes impossible. The disease can also affect the heart, lungs and liver, and NSF can lead to death. Unfortunately, there are no effective treatments for NSF, although some patients have improved following a kidney transplant.

Gadolinium MRI contrast dyes are used in MRIs because they make it far easier for a diagnostician to differentiate between normal and abnormal tissue. While the tests can be done without the gadolinium based contrast agent, they are nowhere near as effective. The FDA has warned that patients with kidney problems not be given Gadolinium based MRI contrast dyes unless it is absolutely necessary. Unfortunately, there are not yet any alternatives to gadolinium based MRI contrast agents.

Gadolinium Based MRI Contrast Agents Put Kidney Patients at Risk for NSF/NSD

Fri, 09 Nov 2007 00:00:00 -0800

Gadolinium based MRI contrast agents have been implicated in at least 1,000 cases of a debilitating disorder called Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NSD) around the world. This horrible disease causes a buildup of collagen in tissues, leading to a severe thickening and hardening of the skin.   NSF/NSD can completely immobilize patients, and in severe cases it can lead to death.

NSF/NSD is a rare disease that so far has affected only people with pre-existing kidney problems. The first case of NSF/NSD was reported in 1997, and it wasn’t mentioned in medical literature until 2000.   NSF/NSD leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF/NSD can progress to the point of causing severe stiffness in joints, and it can lead to death.

There is currently no cure for NSF/NSD, and no one understands its specific cause. However, it is widely believed that gadolinium based MRI contrast agents play a role in the development of this devastating disorder.   Researchers at Yale University have reported that 95-percent of those with NSF/NSD had an MRI that involved a gadolinium based contrast agent two to three months before their symptoms appeared.   Several other studies have also found a link between NSF/NSD and gadolinium based MRI contrast agents. The connection between gadolinium and NSF/NSD is so strong that earlier this year, the Food & Drug Administration (FDA) requested that that the manufacturers of gadolinium based contrast agents update their products’ labels to include a black box warning regarding the risk of NSF/NSD in patients with kidney problems. The FDA also started a monitoring program to track the frequency of NSF/NSD related to gadolinium contrast agents.

Gadolinium based MRI contrast agents are used in MRIs because they make it far easier for a diagnostician to differentiate between normal and abnormal tissue. While the tests can be done without the gadolinium based contrast agent, they are nowhere near as effective. The FDA has warned that patients with kidney problems not be given gadolinium based MRI contrast agents unless it is absolutely necessary. Unfortunately, there are not yet any alternatives to gadolinium based MRI contrast agents.

For patients with NSF/NSD, life can become a living hell.   Their skin can become so hardened that it resembles marble, while joints stiffen to the point that movement becomes impossible. The disease can also affect the heart, lungs and liver, and NSF/NSD can lead to death. Unfortunately, there are no effective treatments for NSF/NSD, although some patients have improved following a kidney transplant.

Gadolinium Based Contrast Agents Used Off-Label in MRAs Pose Even Greater Risk of Causing NSF than if Used in MRIs

Tue, 30 Oct 2007 00:00:00 -0700

Gadolinium based contrast agents used during MRIs, are known to be associated with the onset of Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NSD) in patients with pre-existing kidney disease.   But the use of gadolinium in a procedure call Magnetic Resonance Angiography (MRA) could put these patients at an even greater risk of developing NSF/NSD, because these procedures often use far more gadolinium than a typical MRI. The use of gadolinium contrast agents in MRAs is a growing practice, even though the Food Drug Administration (FDA) never approved gadolinium for MRAs.

An MRA is a variation of a traditional MRI that is used to provide pictures of blood vessels inside the body. In many cases, an MRA can provide information that cannot be obtained from an X-ray, ultrasound, or computed tomography (CT) scan. An MRA is often used to detect aneurysms, blood clots or narrowing caused by plaque buildup in the blood vessels leading to the brain, and it is also used to find similar narrowing in the vessels leading to the lungs, kidneys and legs.

Currently, five gadolinium based contrast agents are approved for use by the FDA. These are Omniscan, Optimark, Magnevist, Multihance and Prohance. Gadolinium contrast agents are used during MRAs for the same reason they are used in MRIs, to help differentiate between normal and abnormal tissue. The gadolinium based contrast agent is injected into the bloodstream right before an individual undergoes an MRA. However, in order to be effective in an MRA, the gadolinium contrast agent must be administered at three times the approved dose. What’s more, this constitutes an off-label use of gadolinium based contrast agents – that is these agents were never approved by the FDA to be used with MRAs.

In 2006, evidence began to emerge that gadolinium based MRI contrast agents were linked to the development of NSF/NSD.   NSF/NSD is a debilitating disease that affects people with pre-existing kidney disease.   The first case of NSF/NSD was reported in 1997, and it wasn’t mentioned in medical literature until 2000.   NSF/NSD leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF/NSD can progress to the point of causing severe stiffness in joints, and it can lead to death. Unfortunately, for many patients with NSF/NSD, the only way to improve kidney function is with a transplant.

In 2006, Dutch researchers discovered that the use of gadolinium based contrast agents had a direct correlation to the development of NSF/NSD in patients with pre-existing kidney problems. Following the 2006 discovery, the FDA warned healthcare professionals that gadolinium based agents had been tied to multiple cases of NSF/NSD. As more studies reinforced the theory that gadolinium based contrast agents were linked to NSF/NSD, the FDA decided to add a black box warning to the labels of these agents in 2007. The FDA also reiterated that gadolinium based contrast agents were not approved for use with MRAs, and the high doses of gadolinium based contrast agents needed in these procedures were also well above the levels approved by the agency.

Off-label use is not illegal, as doctors are free to prescribed approved medications in anyway they see fit. However, off-label marketing of a drug by its manufacturer is illegal.   So far, the FDA has not investigated the five manufacturers of gadolinium based contrast MRI agents to see if they are actively marketing these products for use in MRAs.

NSF / NFD Associated with Gadolinium Based Contrast Agents More Common and Deadly than Previously Thought

Wed, 17 Oct 2007 00:00:00 -0700

Nephrogenic Systemic Fibrosis / Nephrogenic Fibrosing Dermopathy (NSF/NFD), a painful conditions that has been linked to the use of gadolinium based contrast agents used in Magnetic Resonance Imaging (MRI), could be more prevalent than once thought. A recently released study also found that kidney patients with NSF/NFD are far more likely to die than those without the disorder.

NSF/NFD, a disease that affects people with pre-existing kidney disease, leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF/NFD can progress to the point of causing severe stiffness in joints, and it can lead to death.

A new study conducted by researchers at Massachusetts General Hospital has confirmed suspicions that the onset of NSF/NFD is strongly associated with gadolinium based contrast agents. The study, which was published in the October issue of the Journal of Arthritis & Rheumatism, found that kidney patients who had undergone MRIs with gadolinium based contrast agents were 10 times more likely to develop NSF/NFD than patient who had not been exposed to such agents. The investigators also found that 48% percent of the NSF/NFD patients in the study died only two years after being examined by researchers at Massachusetts General Hospital. Among the study participants without NSF/NFD, only 20% died during the same period.

For several years now, gadolinium based contrast agents have been a prime suspect in the sudden appearance of NSF/NFD. The first case of NSF/NFD was not even reported in 1997, and it wasn’t mentioned in medical literature until 2000. In 2006, Dutch researchers first linked gadolinium contrast agents to the onset of NSF/NFD. That same year, the FDA warned health care professionals about the link between gadolinium contrast agents and the occurrence of NSF/NFD. Then in 2007, the FDA requested that that the manufacturers of gadolinium based contrast agents update their products’ labels to include a black box warning regarding the risk of NSF/NFD in patients with kidney problems. The FDA also started a monitoring program to track the frequency of NSF/NFD related to gadolinium contrast agents.

The research done at Massachusetts General Hospital only serves to underscore the danger that gadolinium based contrast agents pose to people with kidney problems. The investigators who conducted this study noted that patients who are scheduled for MRIs that involve the use of gadolinium based contrast agents should always be screened for underlying kidney problems, and those with pre-existing kidney disease should never be exposed to gadolinium.

Gadolinium Contrast Used in MRI / MRA Can Cause NSF & NFD

Wed, 08 Aug 2007 00:00:00 -0700

Gadolinium contrast agents have long been used in Magnetic Resonance Imagining (MRI) to enhance the quality of images. But in some patients, Gadolinium can have a toxic affect, causing a condition known of Nephrogenic Systemic Fibrosis (NSF)

Gadolinium contrast agents are injected into the bloodstream right before an individual undergoes an MRI. The Gadolinium helps the MRI computer to differentiate between normal and abnormal tissue. In 2006, researchers discovered that the use of Gadolinium based contrast agents had a direct correlation to the development of NSF in patients with pre-existing kidney problems. Following the 2006 discovery, the Food and Drug Administration (FDA) warned healthcare professionals that Gadolinium based agents had been tied to multiple cases of NSF. Although these cases were not limited to one Gadolinium based contrast agent, three were most often associated with the onset of NSF. Those three were Ominiscan made by GE Healthcare, Magnevist marketed by Bayer Shering Pharma, and OptiMark manufactured by Mallinckrodt, Inc. At that time the FDA warned physicians to screen patients for kidney problems prior to using a Gadolinium based contrast agents during MRIs.

NSF is a disorder characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. It can take some time after Gadolinium exposure for NSF symptoms to appear, and the disease often progresses very slowly. A July article in the New England Journal of Medicine highlighted one instance of a patient with kidney failure who received a Gadolinium based contrast agent, and whose NSF symptoms developed over a four year period. At this time, there is no treatment or cure for NSF. However, improved kidney function does seem to slow the development of the disease. Unfortunately, for many patients with NSF, the only way to improve their kidney function is with a transplant,

In May 2007, the FDA requested that the manufactures of the five Gadolinium based contrast agents used in MRIs include a boxed warning on product labels highlighting the risk they posed to patients with kidney problems. The FDA warned that patients who are at risk for NSF should be monitored by their doctors, and told to report any symptoms associated with the condition immediately. The FDA has also set up a reporting program so that healthcare providers can report instances of NFS caused by Gadolinium based contrast agents.

Gadolinium based contrast agents could potentially injure millions of people. According to the National Kidney Foundation, some 20 million people have chronic kidney disease. The foundation also estimates that 20 million more are at increased risk for developing chronic kidney problems. It is vital that patients who are about to undergo an MRI speak with their healthcare providers about the risks associated with Gadolinium based contrast agents.

Parker Waichman Alonso LLP, are Investigating Numerous Claims for Injuries Sustained as a Result of Gadolinium Based Contrast Agent Injections Used During MRI Scans

Wed, 23 May 2007 00:00:00 -0700

Parker Waichman Alonso LLP recently learned that the Federal Drug Administration (FDA) has notified healthcare professionals of the Agency’s request for the addition of boxed warnings and new warnings about the risk of Nephrogenic Systemic Fibrosis (NSF) for all Gadolinium based contrast agents. The new warnings require highlights, describing the risk for NSF following exposure to Gadolinium in patients with acute or chronic severe renal insufficiency. The FDA is also requesting the addition of a boxed warning about the risk for NSF.

If you or a loved one believes that you may have sustained Nephrogenic Systemic Fibrosis (NSF), also referred to as Nephrogenic Fibrosining Dermopathy (NFD), please contact our office by visiting www.yourlawyer.com/topics/overview/nsf . Free case evaluations are also available by calling Parker Waichman Alonso LLP at 1-800-LAW-INFO (1-800-529-4636).

In 2006, researchers found there is a direct connection between the development of Nephrogenic Systemic Fibrosis (NSF) and the use of Gadolinium contrast agents during Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA) for those kidney problems.

An MRI scan is performed to obtain a clear detailed image of a patient’s internal organs and tissues and an MRA is used to obtain a detailed image of a patient’s blood vessels. During some MRI and MRA scans, a Gadolinium based contrast agent is injected into the patient to highlight blood vessels so they can be distinguished from other nearby tissues.

Symptoms of Nephrogenic Systemic Fibrosis (NSF) are.

Burning
Itching
Swelling
Hardening and tightening of the skin
Red or dark patches on the skin
Yellow spots on the whites of the eyes
Stiffness in joints and trouble moving or straightening the arms, hands, legs, feet
Pain deep in the hip bones or ribs
Muscle weakness
Death

About Parker Waichman Alonso LLP:

Parker Waichman Alonso LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker Waichman Alonso LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective products, tainted foods, medications and medical devices.

NSF Gadolinium Lawyer MRI Kidney Nephrogenic Systemic Fibrosis Information Contrast Attorney

Wed, 23 May 2007 00:00:00 -0700

Nephrogenic Systemic Fibrosis (NSF) Associated with Gadolinium-based Contrast Agents

Keywords: NSF | Gadolinium | Lawyer | MRI | Kidney | Nephrogenic Systemic Fibrosis | Information | Contrast | Attorney

Nephrogenic Systemic Fibrosis (NSF / NFD) and Gadolinium Contrast Dyes

Recent News

Dying for an MRI - 7 News Investigation (WSVN 7 Fox News Miami/Fort Lauderdale)

NSF Injury Lawyers

The lawyers and attorneys at our firm are offering free case evaluations to people suffering from Nephrogenic Systemic Fibrosis (NSF). NSF has only been seen in people with pre-existing kidney disease who have been exposed to gadolinium contrast dyes used in magnetic resonance imaging (MRI) procedures. If you or a loved one has been diagnosed with this devastating disease, we urge to contact one of our NSF injury lawyers as soon as possible to protect your legal rights.

NSF is a relatively new disease. In fact, The first known diagnosis of NSF occurred in 1997, but it wasn't until September 2000 that details of the disease were published in the medical journal Lancet. The NSF injury lawyers at our firm have accrued a great deal of knowledge about this disease, as well as the gadolinium contrast dyes that cause it. We will use this expertise to make sure our clients receive the compensation they are entitled to under the law.

NSF Symptoms

NSF first presents as a skin condition, and often patients and their doctors don't even realize they are dealing with something extremely serious. In most people the legs are affected first, then the feet, arms and hands. In some NSF patients the trunk of the body is also affected. The symptoms of NSF include:

Unstable or high blood pressure
Tightening and swelling of the skin, typically starting with the legs, moving to the arms, and sometimes the trunk
Thickening of the skin around the joints, restricting movement
Skin which feels “woody” and has a texture similar to that of an orange peel
Red or dark patches of skin
Burning, itching, and/or sharp pains in affected areas
Symmetrical skin lesions, commonly on the ankles and thighs and between the wrists and upper arms
Muscle weakness
Deep bone pain in the hips and ribs
Calcification of soft tissues
Yellow plaques near the eyes

NSF leads to excessive formation of connective tissue in the skin and internal organs. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. Our NSF injury lawyers know how debilitating and frightening this disease can be, and we are committed to representing our clients with the compassion they deserve.

Evidence Linking NSF to Gadolinium Contrast Dyes

Because it is rare, not much is known about NSF, but what studies have been done have consistently shown an association between NSF and gadolinium contrast dyes used in MRI procedures. The NSF injury lawyers at our firm have determined that the makers of gadolinium contrast dyes did not adequately test these products for safety. Our firm intends to hold these manufacturers accountable for their negligence.

In 2006, Dutch researchers where the first to link NSF with the use of gadolinium contrast dyes. In a small study, they discovered that 5 of 9 patients diagnosed with NSF had received a MRI involving use of Omniscan Contrast Dye, a gadolinium based contrast agent manufactured by General Electric.

In May 2006, nephrologists at a St. Louis, Missouri hospital reported a cluster of NSF among patients treated in their dialysis units. The U.S. Centers for Disease Control (CDC) conducted an investigation to determine the number of affected patients and identify risk factors for NSF. Of the 19 patients eventually included in the study, only five had no identified gadolinium exposure within 1 year preceding NSF diagnosis. However, of these, four had gadolinium exposure from 16 to 68 months preceding diagnosis. Thirteen patients had multiple gadolinium-containing contrast exposures during the preceding year.

According to the CDC, the study indicated that exposure to gadolinium-containing contrast agents during MRI studies was linked with the development of NSF. The CDC cautioned that clinicians should be aware of the potential for NSF, and when possible, should avoid use of gadolinium-containing contrast agents in patients with advanced kidney disease.

A Scottish NSF study published in October 2007 looked at 1,826 patients who underwent renal replacement therapy at two Glasgow hospitals between January 1, 2000 and July 1, 2006. Of those patients, 421 underwent an MRI that involved the use of a gadolinium based contrast agent. Fourteen were diagnosed with NSF, and of those, 13 had been exposed to gadolinium during an MRI. The researchers also found that the patients with NSF had received far higher doses of gadolinium than those patients who were exposed to gadolinium but did not develop the disorder.

In 2007 researchers at Yale University reported that 95-percent of those with NSF had an MRI that involved a gadolinium MRI contrast dye two to three months before their symptoms appeared. Around the same time, researchers at Massachusetts General Hospital found that kidney patients who had undergone MRIs with gadolinium contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

In that NSF study, the time between gadolinium-based contrast dye exposure and presentation with NSF ranged between 2 days and 6 years (median time, 76 days). Five patients developed NSF more than 90 days after exposure to gadolinium contrast agents. Of these, three had a time to onset of more than 1 year. Six patients in the NSF group had undergone previous gadolinium-enhanced MRI without apparent complication, and eight went on to undergo further exposure after presentation with NSF.

FDA Warnings

Since 2006, the Food & Drug Administration (FDA) has issued three separate warnings about gadolinium contrast agents and their link to NSF. The agency has also required the makers of the dyes to include a black box warning on their products' labels. Currently, there are five gadolinium contrast dyes approved for use in the US: Omniscan by GE Healthcare; OptiMARK by Mallinckrodt/Tyco Healthcare; Magnevist by Bayer/Schering AG/Berlex; ProHance by Bracco Diagnostics and MultiHance by Bracco Diagnostics.

Following the publication of the Dutch NSF study in 2006, the FDA issued an alert to healthcare providers that gadolinium based agents had been tied to multiple cases of NSF. Although these cases were not limited to one gadolinium based contrast agent, three were most often associated with the onset of NSF. Those three were Ominiscan, Magnevist and OptiMark. At that time the FDA warned physicians to screen patients for kidney problems prior to using gadolinium based contrast agents during MRIs.

In December of 2006, the FDA issued its second public health advisory regarding gadolinium based contrast dyes. At that time, the FDA said it had received 90 reports of patients with moderate to end-stage kidney disease who developed NSF after being exposed to gadolinium based contrast agents. At the time of this alert, the FDA said about 215 patients worldwide were known to have NSF. Of those whose medical history were known, all had been exposed to gadolinium contrast agents prior to diagnosis.

In May 2007, the FDA requested that the manufacturers of the five gadolinium based contrast agents used in MRIs include a boxed warning – the FDA’s strongest possible safety warning – on product labels highlighting the risk they posed to patients with kidney problems. The FDA warned that patients who are at risk for NSF should be monitored by their doctors, and told to report any symptoms associated with the condition immediately. The FDA has also set up a reporting program so that healthcare providers can report instances of NSF caused by gadolinium based contrast agents.

NSF Treatment

There is currently no cure for NSF. Photopheresis, a treatment where blood is temporarily removed from the body and exposed to ultraviolet light before being re-injected into the patient, has been shown to help in some cases of NSF. However, the treatment is expensive - costing about $8000 every two weeks.

Kidney transplants have also been shown to slow the progression of NSF. Other treatments for NSF include:

Oral steroids (prednisone): These medications have helped some patients, but due to their side effects, their use is largely discouraged.
Topical Dovonex: Some patients report improvement from this treatment in early stages of NFD.
Thalidomide: Some patients improve while taking this drug, but its long-term side effects may be an issue.
Plaquenil: Some patients benefit from this drug, but side effects can affect the eyes and it must be closely monitored.
Minocycline (or similar antibiotics): Some patients have reported benefit from this medication, but it can affect the intestinal tract and lead to fungal infections and sun sensitivity.
Pentoxyfilline: There are some reports of success with this medication which theoretically decrease the viscosity of blood and aids circulation and can have anti-oxidant effects.
Physical therapy: Physical therapy, particularly swimming, may help slow the progression of joint problems.

Legal Help for NSF Sufferers and Their Families

Our NSF lawyers are already actively involved in lawsuits against the makers of gadolinium contrast dyes. If you or a loved one are suffering from NSF, and were exposed to a gadolinium contrast dyes prior to diagnoses, you have valuable legal rights. Please fill out our online form or call us at 1-800-LAW-INFO (1-800-529-4636) for a free evaluation of our case.