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

A ProPublica investigation has found that a disproportionate number of Nephrogenic Systemic Fibrosis (NSF) cases have been associated with the use of General Electric’s (GE) Omniscan gadolinium contrast dye. Yet, according to the investigation, published in Business Week, the Food & Drug Administration (FDA) has refused to characterize Omniscan as more problematic than its competitors.

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. More FDA Decision to Treat Omniscan, Other Gadolinium Contrast Dyes Equally Questioned

Bayer AG has settled some lawsuits involving its gadolinium contrast dye, Magnevist. Plaintiffs in the lawsuits claimed that Magnevist had caused Nephrogenic Systemic Fibrosis (NSF), a potentially fatal condition that develops in people with pre-existing kidney disease.

Gadolinium contrast dyes like Magnevist 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 Bayer’s Magnevist, these dyes include: Omniscan by GE Healthcare; OptiMARK by Mallinckrodt/Tyco Healthcare; 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.

According to Bloomberg.com, as of February Bayer faced 241 lawsuits over Magnevist. The company confirmed that it had entered into settlement discussions for about 40 of those.

“We can confirm that we have reached agreements in principle with several of the plaintiffs in the U.S. to settle without admission of liability”, a Bayer spokesperson told Bloomberg.com

An attorney for NSF plaintiffs told Bloomberg.com that the settlements at this time were tentative, and that dollar amounts could not be disclosed. A second plaintiffs’ attorney said that for now, Bayer was settling cases in which a biopsy confirmed a diagnosis of NSF, and Magnevist was the only contrast agent used.Bad Boys II movie

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 Gabriel movie full (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 meta-analysis concluded that their findings suggest a “potent and significant” association between gadolinium contrast dyes and NSF among patients with advanced chronic kidney disease.

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.  More Gadolinium Contrast Dye Risks Can be Reduced Through Screening

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.   More Vasovist Approved for MRA Procedures

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.   More Another Study Links NSF to Gadolinium Contrast Dyes

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. More NSF Lawsuits Moving Ahead in Multidistrict Litigation

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

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. More After 2 Years, NSF Sufferer Wins Fight with Insurer