Gadolinium contrast dyes are used to enhance images during MRI, and sometimes MRA, procedures. NSF is a rare, debilitating and often fatal disease that appears to only affect people with severe kidney disease who have been exposed to these products. In the U.S., Omniscan and all other Gadolinium dyes currently in use have been required to bear a black box warning regarding the potential for NSF since 2007, and the Food & Drug Administration (FDA) is currently considering even tougher labeling requirements for the drugs.
Thomsen began speaking out about NSF and its association with Gadolinium dyes in 2007, after about 30 patients at Copenhagen University Hospital developed the condition. According to The Guardian, the UK libel suit alleges that Thomsen claimed GE Healthcare marketed Omniscan despite knowing about its adverse side-effects; suppressed the information and concealed it from radiologists; and exposed patients who were administered Omniscan to the danger of NSF. According to The Guardian, GE Healthcare says the alleged defamation occurred during a 15-minute presentation Thomas made to fellow radiologists in 2007 at Oxford University, and in statements made in an article published in Thomsen's name in the journal Imaging Management.
GE Healthcare has already spent Ł380,000, or $614,000 USD, to sue Thomsen in the UK. According to The Guardian, if the drug giant wins, Thomsen will have to pay its costs. The case is not expected to reach court for another 18 months.
According to The Guardian, Thomsen's lawyers are using a concept known as "qualified privilege" to defend him. As a doctor, Thomsen claims he had a duty to report his experience with Omniscan, and his audience had a legitimate interest in receiving it. For its part, GE Healthcare asserts that qualified privilege doesn't protect Thomsen because he acted "maliciously".
For now, because of the libel claim against him, The Guardian says Thomsen has stopped lecturing in the UK. He also claims patients in England are being put at serious risk because he and other scientists are prevented from sharing their knowledge as a result of the way the libel courts in the country operate.
The recommendation came after the advisory panel reviewed data that indicated Omniscan, OptiMark and Bayer's Magnevist carried a higher risk of NSF than other Gadolinium dyes currently on the market. Though some panel members pushed for similar labeling changes for Magnevist, the members were unable to reach consensus on that issue. The panel did not take a formal vote, but an FDA official said its recommendation on Omniscan and OptiMark represented a "preponderance" of opinion among the members.
Dr. Dr. Sidney Wolfe, a panel member and head of Public Citizen’s Health Research Group, was among those pushing for stronger warnings on Omniscan and OptiMark. According to Reuters, Dr. Wolfe expressed concerns that leaving the same warning on all the drugs “may cause more problems than if you distinguish between the drugs as best as you can."
According to ProPublica, following the daylong advisory panel meeting, officials from the FDA said they would take the recommendations under consideration when deciding on what, if any, steps to take in regards to Omniscan, OptiMark and other Gadolinium agents used in MRI and MRA procedures.
Since 2007, all Gadolinium agents have carried the same black box warning - the FDA's strongest safety notice - regarding the risk of NSF. But earlier this fall, the agency released a risk assessment that indicated that Omniscan, OptiMark and Magnevist carried a higher risk of the debilitating, and often fatal, disease. The assessment cited 382 cases in which Omniscan was named as the single imaging agent in an NSF report. Magnevist was named in 195 reports and OptiMark in 35. The FDA put Omniscan's market share from 2005 through 2007 at only 32%, compared with 49% for Magnevist and 10% for OptiMark.
According to ProPublica, one particular riveting portion of last week's advisory panel meeting involved testimony from SF patient from North Carolina. She described in detail the "torture" she has experienced since contracting NSF after undergoing an MRI in 2006. The disease initially presented as swelling in her ankles migrated up through her organs and body. The woman, who is confined to a wheelchair, told the panel that today, her bones now feel as though they are "in a vise," ProPublica said.
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. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death. While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a Gadolinium contrast dye.
Last month, following the release of the FDA risk assessment, Covidien announced it would be changing the OptiMark label to contraindicate its use in patients with severe kidney disease.
Omniscan, OptiMark and Magnevist have already been named in over 500 lawsuits filed by people who claim they or their loved ones developed NSF following exposure to one or more of the Gadolinium-based MRI contrast dyes. Most NSF lawsuits filed around the country have been consolidated in federal court in the Northern District of Ohio.
Bayer's Magnevist, as well other Gadolinium contrast dyes, including General Electric's Omniscan and Covidien's OptiMark, have been named in over 500 lawsuits filed by people who claim they or their loved ones developed NSF following exposure to one or more of the Gadolinium-based MRI contrast dyes.
NSF is an often-fatal 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.
There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death. While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a Gadolinium contrast dye.
In 2007, the U.S. Food & Drug Administration (FDA) mandated a black box warning about the risk of NSF for all Gadolinium agents. The agency is now considering tougher warnings that could restrict the use of some Gadolinium agents to only patients without severe kidney disease, following a risk assessment that found Omniscan, OptiMark and Magnevist appeared to carry a higher risk of NSF than other Gadolinium products on the market.
Most NSF lawsuits filed around the country have been consolidated in federal court in the Northern District of Ohio. However, according to Law.com, the Magnevist lawsuit scheduled for trial in January is one of 20 to 30 California NSF lawsuits that have been consolidated before San Francisco Superior Court Judge Richard Kramer. While this suit only names Bayer as a defendant, General Electric is also a major defendant in the California litigation.
Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. A mountain of evidence indicates that NSF only affects people with severe kidney disease who have been exposed to Gadolinium agents.
This horrific and often deadly disease leads 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 are currently no effective treatments for NSF.
At yesterday's meeting, the FDA advisory panel recommended a stronger NSF warning for both Covidien Inc.'s OptiMark and General Electric's Omniscan that contraindicates the use of these agents in people with severe kidney disease, according to a Reuters report. Reuters also said that some on the FDA panel also pushed for a similar warning on Bayer's Magnevist, but the advisers were not able to reach a consensus on that issue.
As we've reported previously, all Gadolinium contrast dyes already bear a black box warning - the FDA's strongest safety warning - about the risk of NSF. That black box was mandated in 2007.
According to Reuters, Dr. Dr. Sidney Wolfe, a panel member and head of Public Citizen's Health Research Group, was among those pushing for stronger warnings on Omniscan and Optimark. Leaving the same warning on all the drugs "may cause more problems than if you distinguish between the drugs as best as you can," Dr. Wolfe said.
Members of the FDA advisory panel said labeling for the products needs to keep pace with how the drugs are being used in the real world. According to a Dow Jones report, radiologists speaking at yesterday's meeting told the FDA that clinicians have essentially stopped using Gadolinium products in patients with severe kidney disease. The panel was also told that the number of NSF reports have dropped significantly since the FDA mandated the black box.
The panel was not asked by the FDA to actually vote on the issue of a new warning for any of the Gadolinium products, but the recommendation on OptiMark and Omniscan did represent a "preponderance" of opinion on the issue, Reuters said.
The FDA will make the final decision on any label changes. The agency does not have to follow recommendations of advisory panels, but it usually does so.
Reuters is reporting that the panel supported new warnings for General Electric's Omniscan and Covidien Inc.'s OptiMark that say they should not be used in patients with severe kidney disease. The panel felt that Omniscan and OptiMark. along with Bayer's Magnevist appeared to carry a higher NSF risk than similar products. The recommendations represented a "preponderance of opinion" on the panel, and not a formal vote, Reuters said.
Meanwhile, Dow Jones News Service is reporting that the same FDA panel also recommended restricting the use of Magnevist to patients without kidney severe kidney disease. However, according to Reuters, there was less consensus on the panel in regards to Magnevist.
The FDA is not required to follow the recommendations of its advisory panels, but it usually does so.
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. It appears that NSF only develops in people with pre-existing kidney disease. In 2007, the FDA asked the manufacturers of all Gadolinium contrast dyes to add a black box warning to the product labels about their association with NSF. Since the warning, the FDA and the makers of Gadolinium contrast dyes have continued to collect data about their association with NSF.
According to documents released last month by the FDA in advance of today's meeting, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMark. The lowest risk was associated with Prohance and Multihance, both marketed by Bracco Diagnotics. However, the FDA was unable to rule out a risk for any of the agents.
FDA staff said it was too early to reach conclusions about Bayer's Eovist and Lantheus Medical Imaging's Ablavar, two recently approved Gadolinium agents.
According to Dow Jones, at today's FDA advisory panel meeting, radiologists said that clinicians have essentially stopped using Gadolinium agents in patients with severe kidney disease. The panel was also told that reports of NSF have dropped significantly since the black box warning was mandated.
Last month, Europe's health regulatory agency said Omniscan, Magnevist and OptiMark shouldn't be used in patients with severe kidney problems.
As we previously reported, Covidien has already decided to modify the label of OptiMark to contraindicate its use in patients with severe kidney impairment because of its association with NSF.
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. They are: OptiMARK, by Covidien Inc., 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.
Since the 2007 black box warning, the FDA has continued to collect data on Gadolinium contrast dyes and NSF. According to documents released last month 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.
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.
That issue will be addressed at the December 8 advisory panel meeting. However, as we previously reported, Covidien has already decided to modify the label of OptiMark to contraindicate its use in patients with severe kidney impairment because of its association with NSF. At the time, 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.
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. 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
According to the St. Luke's Hospital lawsuit, the plaintiff, who suffered from kidney disease, was administered a contrast dye in January 2005 in conjunction with an MRI. The plaintiff was administered a contrast agent and underwent magnetic resonance angiography (MRA) on Oct. 10, 2007, at St. Luke’s. On Nov. 6, 2007, MRA, again requiring the use of a contrast agent, was performed on the plaintiff at the hospital.
Following these procedures, the plaintiff began to suffer symptoms typical of NSF, and was diagnosed with the disorder in early 2007.
The lawsuit alleges that the hospital was negligent when it administered Gadolinium contrast dyes to a patient with renal failure. The suit also asserts that the unknown makers of the dyes are strictly liable for the patient’s injury because they defectively designed the contrast agents and knowingly failed to warn consumers about the health risks. Finally, the suit alleges, the products were negligently designed and that the companies negligently and fraudulently represented to patients that they were safe.
This lawsuit is just one of hundreds filed in the past couple of years by victims of NSF. Since the FDA mandated the black box warning for all Gadolinium contrast dyes in 2007, evidence of a link between the products and NSF has only grown stronger.
Earlier this month, we reported that the FDA is still looking into the association between Gadolinium agents and NSF. 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.
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. They are: 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.
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.
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.
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.
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.
Since the 2007 warning, hundreds of NSF victims have sued the makers of Gadolinium contrast dyes over their injuries. Of 400 lawsuits currently pending in a Multidistrict Litigation, ProPublica says all but about 100 involve Omniscan. Of the 300 that name Omniscan, 70 percent do so exclusively. That's strange when you consider that Omniscan is just the second biggest player in the market. According to ProPublica, Bayer HealthCare has some 50 percent of the U.S. market, while GE is next, with about 30 percent.
According to ProPublica, the FDA and GE knew in 2007 that Omniscan was involved in a disproportionate number of NSF reports. But The FDA added the same warning to all Gadolinium contrast dies, even though two of its staff doctors had determined that Omniscan is riskier than its rivals. One of the doctors told ProPublica that she had found that medical and sales data indicated Omniscan "had most of the cases and less of a share of the market, so I believed Omniscan was the worst player." In April 2006, the second doctor told the FDA that "a contraindication for Omniscan is warranted" for patients with severe kidney disease. According to ProPublica, a contraindication would have basically banned the use of Omniscan in those patients. According to ProPublica, the FDA issued the 2007 warning after GE had urged it to treat all of the Gadolinium dyes as equally risky.
Considering the strong correlation between Omniscan and NSF, some have criticized the FDA's stance. Dr. Emanuel Kanal, a professor at the University of Pittsburgh Medical Center, told ProPublica that the FDA's decision was "inappropriate and indefensible," and "endangers American citizens". ProPublica was also quick to point out that Kanal was not working for any parties involved in NSF lawsuits.
Kanal also criticized GE for actions it took after the 2007 blanket warning was issued. At that time, the company reinstated requirements that customers purchase certain minimum amounts of Omniscan in order to receive financial incentives. According to ProPublica, Kanal confronted GE managers over what he considered their "inappropriate" decision to induce customers to buy Omniscan.
According to ProPublica, the FDA has defended its decision on the 2007 Gadolinium contrast warning. However, the agency said it would meet with Kanal to look at new data.
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
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.
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.
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 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.
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 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.
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."
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.
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 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 the lawsuit, the plaintiff received an injection of Magnevist Gadolinium contrast dye on March 23, 2001. The Brooklyn Center, Minn. woman was diagnosed with NSF in February 2007. The lawsuit, which names Bayer-Schering and its subsidiary Berlex Laboratories as defendants, says that the plaintiff continues to suffer from the severe, debilitating and progressive fibrotic changes associated with NSF. This has permanently disabled, disfigured and severely impaired the plaintiff.
The lawsuit alleges that Magnevist is defective, and that the defendants failed to adequately test Magnevist and failed to warn patients about its potential to cause NSF. The lawsuit further alleges that the chemical make-up of Magnevist 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.
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.
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.
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.