Kidney Patients Should be Aware of Nsf, Dangers of Gadolinium Contrast Dyes
November 3rd, 2008 | by admin |
Laurie Villanueva asked:
Since it was first identified in 1997, Nephrogenic Systemic Fibrosis (NSF) has devastated the lives of hundreds of people with pre-existing kidney disease who were exposed to gadolinium contrast dyes used in MRI and MRA scans. People with kidney problems need to beware that exposure to gadolinium contrast dyes could cause them to develop this disabling, and possibly fatal disorder.
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. Patients with kidney problems who are scheduled for an MRI or MRA scan should speak with their healthcare professional beforehand, to find out if he or she plans to prescribe one of the gadolinium contrast dyes.
According to various studies, Omniscan is the gadolinium contrast dye associated with the majority of reported NSF cases. Most of the many NSF lawsuits filed in the U.S. involve Omniscan and name GE Healthcare as a defendant. However, all brands of gadolinium contrast dyes have the potential to cause NSF.
Because of its rarity, NSF often proves difficult to identify. Early on, many NSF victims - and often their doctors - may believe that they are suffering from a minor skin condition or a standard case of high blood pressure. Many NSF victims have reported that it took many visits to several specialists before they finally received a proper diagnoses. In many cases, it is only after more severe symptoms appear that NSF is finally diagnosed.
Patients with NSF develop a skin thickening and fibrosis which is usually symmetrical, and typically of the upper and lower extremities. In some cases the progression is rapid leading to joint contractures confining the patient to a wheelchair. The disorder can affect the internal organs, leading to cardiomyopathy, pulmonary fibrosis, pulmonary hypertension, diaphragmatic paralysis and in severe cases death.
Unfortunately, there is no cure for NSF. However, some treatments can alleviate symptoms and slow its progression. Initially, a physician might prescribe physical therapy to reduce or limit the stiffness associated with NSF. Exercise, particularly swimming, may also help slow the progression of joint problems.
Photopheresis, a treatment where blood is temporarily removed from the body and exposed to ultraviolet light before being re-injected into the patient, has shown some encouraging results. Unfortunately, this expensive treatment (costing around $8000 every two weeks) is considered experimental, and is not always covered by insurance. Kidney transplants have also been known to halt the progression of NSF.
Other treatments that have been known to help NSF patients include oral steroids such as prednisone, topical Dovanoex, Plaquenil, Minocycline or similar antibiotics, and Pentoxyfilline. However, many of these treatments present a risk of serious side effects, so their usefulness is limited.
Because NSF is a relatively new and rare disease, it remains something of a mystery. However, all of the NSF research conducted up to this point has shown a convincing connection between this disease and gadolinium contrast dyes. The first study to make this connection was done by Dutch researchers in 2006, when they reported that of 9 NSF patients, 5 had been exposed to gadolinium contrast dyes.
Several other studies soon followed. One of the largest, conducted by Scottish researchers, looked at 1,826 patients who underwent dialysis at two Glasgow hospitals between January 1, 2000 and July 1, 2006. Of the 421 who underwent an MRI that involved the use of a gadolinium based contrast agent, 14 were diagnosed with NSF. 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.
Since 2006, the Food & Drug Administration (FDA) has issued three separate warnings regarding gadolinium contrast dyes and their association with NSF. The final warning, issued in May 2007, included an announcement that the makers of gadolinium contrast dyes were now including a black box warning - the FDA’s strongest safety warning - on the labels of these products.
Because there is no cure, doctors have been advised to avoid gadolinium exposure in people with kidney disease. However, as there are no alternatives to gadolinium contrast dyes, this is not always possible. In such cases, the contrast agents should be used at the lowest dose possible. The FDA has also said that doctors might want to consider immediate dialysis following exposure to gadolinium in patients already undergoing such treatment. Theoretically, dialysis might help eliminate gadolinium from the body.
Since the association between gadolinium contrast dyes and NSF has become known, the manufacturers of these products have been named in hundreds of lawsuits filed by NSF sufferers and their families. At last count, 391 such cases were pending in both state and federal court. Of those, 287 have been filed in a Multidistrict Litigation in the U.S. District Court for the Northern District of Ohio. In state courts, 53 are pending New Jersey, 14 in Pennsylvania, 25 in California, 3 in Alabama, 6 in Illinois, and 1 each in Missouri, Delaware, and New York. It is expected that more NSF lawsuits will be filed in the future.
Alex
Since it was first identified in 1997, Nephrogenic Systemic Fibrosis (NSF) has devastated the lives of hundreds of people with pre-existing kidney disease who were exposed to gadolinium contrast dyes used in MRI and MRA scans. People with kidney problems need to beware that exposure to gadolinium contrast dyes could cause them to develop this disabling, and possibly fatal disorder.
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. Patients with kidney problems who are scheduled for an MRI or MRA scan should speak with their healthcare professional beforehand, to find out if he or she plans to prescribe one of the gadolinium contrast dyes.
According to various studies, Omniscan is the gadolinium contrast dye associated with the majority of reported NSF cases. Most of the many NSF lawsuits filed in the U.S. involve Omniscan and name GE Healthcare as a defendant. However, all brands of gadolinium contrast dyes have the potential to cause NSF.
Because of its rarity, NSF often proves difficult to identify. Early on, many NSF victims - and often their doctors - may believe that they are suffering from a minor skin condition or a standard case of high blood pressure. Many NSF victims have reported that it took many visits to several specialists before they finally received a proper diagnoses. In many cases, it is only after more severe symptoms appear that NSF is finally diagnosed.
Patients with NSF develop a skin thickening and fibrosis which is usually symmetrical, and typically of the upper and lower extremities. In some cases the progression is rapid leading to joint contractures confining the patient to a wheelchair. The disorder can affect the internal organs, leading to cardiomyopathy, pulmonary fibrosis, pulmonary hypertension, diaphragmatic paralysis and in severe cases death.
Unfortunately, there is no cure for NSF. However, some treatments can alleviate symptoms and slow its progression. Initially, a physician might prescribe physical therapy to reduce or limit the stiffness associated with NSF. Exercise, particularly swimming, may also help slow the progression of joint problems.
Photopheresis, a treatment where blood is temporarily removed from the body and exposed to ultraviolet light before being re-injected into the patient, has shown some encouraging results. Unfortunately, this expensive treatment (costing around $8000 every two weeks) is considered experimental, and is not always covered by insurance. Kidney transplants have also been known to halt the progression of NSF.
Other treatments that have been known to help NSF patients include oral steroids such as prednisone, topical Dovanoex, Plaquenil, Minocycline or similar antibiotics, and Pentoxyfilline. However, many of these treatments present a risk of serious side effects, so their usefulness is limited.
Because NSF is a relatively new and rare disease, it remains something of a mystery. However, all of the NSF research conducted up to this point has shown a convincing connection between this disease and gadolinium contrast dyes. The first study to make this connection was done by Dutch researchers in 2006, when they reported that of 9 NSF patients, 5 had been exposed to gadolinium contrast dyes.
Several other studies soon followed. One of the largest, conducted by Scottish researchers, looked at 1,826 patients who underwent dialysis at two Glasgow hospitals between January 1, 2000 and July 1, 2006. Of the 421 who underwent an MRI that involved the use of a gadolinium based contrast agent, 14 were diagnosed with NSF. 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.
Since 2006, the Food & Drug Administration (FDA) has issued three separate warnings regarding gadolinium contrast dyes and their association with NSF. The final warning, issued in May 2007, included an announcement that the makers of gadolinium contrast dyes were now including a black box warning - the FDA’s strongest safety warning - on the labels of these products.
Because there is no cure, doctors have been advised to avoid gadolinium exposure in people with kidney disease. However, as there are no alternatives to gadolinium contrast dyes, this is not always possible. In such cases, the contrast agents should be used at the lowest dose possible. The FDA has also said that doctors might want to consider immediate dialysis following exposure to gadolinium in patients already undergoing such treatment. Theoretically, dialysis might help eliminate gadolinium from the body.
Since the association between gadolinium contrast dyes and NSF has become known, the manufacturers of these products have been named in hundreds of lawsuits filed by NSF sufferers and their families. At last count, 391 such cases were pending in both state and federal court. Of those, 287 have been filed in a Multidistrict Litigation in the U.S. District Court for the Northern District of Ohio. In state courts, 53 are pending New Jersey, 14 in Pennsylvania, 25 in California, 3 in Alabama, 6 in Illinois, and 1 each in Missouri, Delaware, and New York. It is expected that more NSF lawsuits will be filed in the future.
Alex
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