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.
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.
NSF/NFD 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/NFD 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.
There is currently no cure for NSF/NFD, 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/NFD 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/NFD 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/NFD, 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/NFD can lead to death. Unfortunately, there are no effective treatments for NSF/NFD, although some patients have improved following a kidney transplant.
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.
The Scottish Gadolinium MRI contrast agent study 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/NFD, and of those, 13 had been exposed to Gadolinium during an MRI. The researchers also found that the patients with NSF/NFD had received far higher doses of Gadolinium than those patients who were exposed to Gadolinium but did not develop the disorder.
The Scottish study was the second published this month that confirmed the link between NSF/NFD and Gadolinium based contrast agents. A study conducted by researchers at Massachusetts General Hospital, 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.
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 Food & Drug Administration (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 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.
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.
In their report, the Scottish researchers noted that the link between NSF/NFD and Gadolinium based contrast agents has been accepted by most of the worldwide medical establishment. They suggest that Gadolinium contrast agents be avoided altogether or at least in patients with pre-existing kidney problems. And in cases where Gadolinium is the only alternative, the lowest possible dose should be used.
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 & NSD 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.
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. It can take some time after Gadolinium exposure for NSF/NSD symptoms to appear, and the disease often progresses very slowly. At this time, there is no treatment or cure for NSF/NSD. However, improved kidney function does seem to slow the development of the disease. Unfortunately, for many patients with NSF/NSD, the only way to improve their kidney function is with a transplant.
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/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. Although these cases were not limited to one Gadolinium based contrast agent, three were most often associated with the onset of NSF/NSD. Those three were Omniscan 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
In May 2007, the FDA 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. People who are at risk for NSF/NSD 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/NSD caused by Gadolinium based contrast agents.
According to the “Dear Healthcare Professional” letter, as of today, the FDA says it is aware of 250 cases of NSF/NSD associated with the use of Gadolinium based contrast agents.
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.