All gadolinium contrast dye labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration, the FDA said.

Gadolinium-based contrast dyes are intravenous drugs approved by the FDA for use with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) to help detect abnormalities of body organs, blood vessels, and other tissues. Since 2007, all gadolinium agents sold in the U.S. have carried the same black box warning – the FDA’s strongest safety notice – regarding the risk of NSF.

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 is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes

In a statement, the FDA said the label changes announced today are intended to help ensure gadolinium dyes are used appropriately, and that patients at risk for NSF who receive these agents are actively monitored for the development of the disease.

For now, because of the libel claim against him, The Guardian says Henrick Thomsen has stopped lecturing in the UK. The doctor 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.

Thomsen was one of the first doctors to speak out about a potential link between Omniscan and NSF in  2007, after about 30 patients at Copenhagen University Hospital  where he worked developed the condition.  According to The Guardian,  the UK libel suit alleges that Thomsen defamed GE Healthcare, and that his claims regarding Omniscan were malicious.

GE Healthcare has already spent £380,000, 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.

NSF is a rare, debilitating and often fatal disease that appears to  only affect people with severe kidney disease who have been exposed to gadolinium contrast dyes, like Omniscan.  In the U.S. where the drugs have been required to bear a black box warning regarding the potential for NSF since 2007, the Food & Drug Administration (FDA) is currently considering tougher labeling requirements for the Omniscan and other gadolinium dyes.

The California Magnevist lawsuit is scheduled for trial in January, and  is one of  20 to 30 NSF lawsuits in the state that have been consolidated before San Francisco Superior Court Judge Richard Kramer.  While this suit only names Bayer as a defendant, General Electric, the maker of Omniscan gadolinium contrast dye, is also a major defendant in the California litigation.

According to  Law.com, the outcome of the California Magnevist trial could be a good indicator of how  NSF plaintiffs in similar lawsuits will fare.

Most NSF lawsuits filed around the country have been consolidated in federal court in the Northern District of Ohio.  These products 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. 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.

According to the lawsuit,  the plaintiff was administered a gadolinium agent at St. Luke’s Hospital in Chesterfield, Mo. 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, another MRA, again requiring the use of a contrast agent, was performed on the plaintiff at the hospital.

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.

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

Earlier this month, 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.

The 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%.  This means that  dialysis patients had a 77-fold higher risk of NSF, while kidney transplant patients had a 69-fold higher risk of the disease.

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 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.

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.

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.  By November, attorneys for both sides must also choose 10 cases each  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, lawyers for plaintiffs must also submit expert reports limited to any generic experts they may call in the initial trials.

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.   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.

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.

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.

Like all people with NSF,  Jeannie Deason was a kidney patient who developed the condition after she was exposed to gadolinium contrast dyes that are used in MRI procedures. Deason’s NSF has progressed to the point where her legs and right arm have become frozen in a bent position. During the fight with TennCare her condition deteriorated to the point where she needs someone to stay with her 24 hours a day. Now she spends her days in bed, limbs throbbing, only getting up when her parents help her go to the bathroom. She even had to miss her daughter’s graduation.

The treatment that Deason hopes will restore some normalcy to her life is called extracorporeal photopheresis. It involves removing blood from a patient’s body, exposing it to ultraviolet light and then re-infusing the blood into the body. It’s believed that the treated blood alters the body’s immune system so it can better fight the disease. It can cost around $8000 for one treatment.

Deason’s physician, Dr. John Zic, an assistant professor of dermatology at Vanderbilt University who has treated four patients in this way, told the Tennessean he has seen dramatic results. One patient who was initially unable to close her hand could use a pen to sign documents after three months of treatment. Another patient had significant joint stiffness and difficulty walking. After about seven months, the patient was walking without a significant limp. In all, three of Zic’s patients improved and one died because of issues with dialysis treatment, not because the treatment was ineffective

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.

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.

The lawsuit, which also  names Bayer-Schering subsidiary Berlex Laboratories as a defendant, 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. 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.

The plaintiff in the Magnevist lawsuit is represented by the law firm of Parker Waichman Alonso LLP.

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 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 growing. 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.

The Food & Drug Administration (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.

The 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.

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.