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. (more…)

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. (more…)

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…)

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…)

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. (more…)

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. (more…)

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…)

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…)

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…)

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…)