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Nephrogenic Systemic Fibrosis (NSF) Associated with Gadolinium-based Contrast Agents

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Nephrogenic Systemic Fibrosis (NSF / NFD) and Gadolinium Contrast Dyes

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NSF Injury Lawyers

The lawyers and attorneys at our firm are offering free case evaluations to people suffering from Nephrogenic Systemic Fibrosis (NSF).  NSF has only been seen in people   with pre-existing kidney disease who have been exposed to gadolinium contrast dyes used in magnetic resonance imaging (MRI) procedures.  If you or a loved one has been diagnosed with this devastating disease, we urge to contact one of our NSF injury lawyers as soon as possible to protect your legal rights.

NSF is a relatively new disease.  In fact, The first known diagnosis of NSF occurred in 1997, but it wasn't until September 2000 that details of the disease were published in the medical journal Lancet.  The NSF injury lawyers at our firm have accrued a great deal of knowledge about this disease, as well as the gadolinium contrast dyes that cause it.  We will use this expertise to make sure our clients receive the compensation they are entitled to under the law.

NSF Symptoms

NSF 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.  The symptoms of NSF include:
 

• Unstable or high blood pressure
• Tightening and swelling of the skin, typically starting with the legs, moving to the arms, and sometimes the trunk
• Thickening of the skin around the joints, restricting movement
• Skin which feels “woody” and has a texture similar to that of an orange peel
• Red or dark patches of skin
• Burning, itching, and/or sharp pains in affected areas
• Symmetrical skin lesions, commonly on the ankles and thighs and between the wrists and upper arms
• Muscle weakness
• Deep bone pain in the hips and ribs
• Calcification of soft tissues
• Yellow plaques near the eyes

NSF leads to excessive formation of connective tissue in the skin and internal organs. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.  Our NSF injury lawyers know how debilitating and frightening this disease can be, and we are committed to representing our clients with the compassion they deserve.

Evidence Linking NSF to Gadolinium Contrast Dyes

Because it is rare, not much is known about NSF, but what studies have been done have consistently shown an association between NSF and gadolinium contrast dyes  used in MRI procedures. The NSF injury lawyers at our firm have determined that the makers  of gadolinium contrast dyes did not adequately test these products for safety.  Our firm intends to hold these manufacturers accountable for their negligence.

In 2006, Dutch researchers where the first to link NSF with the use of gadolinium contrast dyes.  In a small study, they discovered that 5 of 9 patients diagnosed with NSF had received a MRI involving use of Omniscan Contrast Dye, a gadolinium based contrast agent manufactured by General Electric.

In May 2006, nephrologists at a St. Louis, Missouri hospital reported a cluster of NSF among patients treated in their dialysis units.  The U.S. Centers for Disease Control (CDC) conducted an investigation to determine the number of affected patients and identify risk factors for NSF.  Of the 19 patients eventually included in the study, only five had no identified gadolinium exposure within 1 year preceding NSF 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 NSF.   The CDC cautioned that clinicians should be aware of the potential for NSF, and when possible, should avoid use of gadolinium-containing contrast agents in patients with advanced kidney disease.

A Scottish NSF study published in October 2007 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, and of those, 13 had been exposed to gadolinium during an MRI. The researchers also found that the patients with NSF had received far higher doses of gadolinium than those patients who were exposed to gadolinium but did not develop the disorder.

In 2007 researchers at Yale University 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.  Around the same time, researchers at Massachusetts General Hospital 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 that NSF study, the time between gadolinium-based contrast dye exposure and presentation with NSF ranged between 2 days and 6 years (median time, 76 days). Five patients developed NSF more than 90 days after exposure to gadolinium contrast agents. Of these, three had a time to onset of more than 1 year. Six patients in the NSF group had undergone previous gadolinium-enhanced MRI without apparent complication, and eight went on to undergo further exposure after presentation with NSF.

 FDA Warnings

Since 2006, the Food & Drug Administration (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. Currently, there are five gadolinium contrast dyes approved for use in the US: Omniscan by GE Healthcare; OptiMARK by Mallinckrodt/Tyco Healthcare; Magnevist by Bayer/Schering AG/Berlex; ProHance by Bracco Diagnostics and MultiHance by Bracco Diagnostics. 

Following the publication of the Dutch NSF study in 2006, the FDA issued an alert to healthcare providers 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, Magnevist and OptiMark. At that time the FDA warned physicians to screen patients for kidney problems prior to using gadolinium based contrast agents during MRIs.

 In December of 2006, the FDA issued its second public health advisory regarding gadolinium based contrast dyes.  At that time, the FDA said it had received  90 reports of patients with moderate to end-stage kidney disease who developed NSF after being exposed to gadolinium based contrast agents. At the time of this alert, the FDA said about 215 patients worldwide were known to have NSF. Of those whose medical history were known, all had been exposed to gadolinium contrast agents prior to diagnosis.

In May 2007, the FDA requested that the manufacturers of the five gadolinium based contrast agents used in MRIs include a boxed warning – the FDA’s strongest possible safety 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 NSF caused by gadolinium based contrast agents.

NSF Treatment

There is currently no cure for NSF. Photopheresis, a treatment where blood is temporarily removed from the body and exposed to ultraviolet light before being re-injected into the patient, has been shown to help in some cases of NSF.  However, the treatment is expensive - costing about $8000 every two weeks.

Kidney transplants have also been shown to slow the progression of NSF.  Other treatments for NSF include:

• Oral steroids (prednisone): These medications have helped some patients, but due to their side effects, their use is largely discouraged.
• Topical Dovonex: Some patients report improvement from this treatment in early stages of NFD.
• Thalidomide: Some patients improve while taking this drug, but its long-term side effects may be an issue.
• Plaquenil: Some patients benefit from this drug, but side effects can affect the eyes and it must be closely monitored.
• Minocycline (or similar antibiotics): Some patients have reported benefit from this medication, but it can affect the intestinal tract and lead to fungal infections and sun sensitivity.
• Pentoxyfilline: There are some reports of success with this medication which theoretically decrease the viscosity of blood and aids circulation and can have anti-oxidant effects.
• Physical therapy: Physical therapy, particularly swimming, may help slow the progression of joint problems.

Legal Help for NSF Sufferers and Their Families

Our NSF lawyers are already actively involved in lawsuits against the makers of gadolinium contrast dyes.  If you or a loved one are suffering from NSF, and were exposed to a gadolinium contrast dyes prior to diagnoses, you have valuable legal rights.  Please fill out our online form or call us at 1-800-LAW-INFO (1-800-529-4636) for a free evaluation of our case.