The 38-year-old Santa Barbara resident said what happened to her is “devastating.”

The issue involves magnetic resonance imaging scans that include the use of a contrast dye containing gadolinium.

For people with healthy, functioning kidneys, the risk of using the element gadolinium to pinpoint potential health problems in MRI scans is zero.

“Gadolinium is extremely safe,” said neuroradiologist David Seidenwurm at Radiological Associates of Sacramento.

But, for people with kidney disease, the use of gadolinium poses a significant health risk. The risk is so significant that the Food and Drug Administration issued a warning for gadolinium this year.

Dr. Philip LeBoit of the University of California, San Francisco first discovered this problem. The disease is called nefrogenic systemic fibrosis, or NSF.

“It can have severe toxic effects,” LeBoit said.

The concern is that the chemicals that surround the gadolinium and make it safe for use in the human body are in some cases breaking down. For those patients with weakened kidneys, they cannot sufficiently rid the body of the gadolinium. That has led to toxic effects for an estimated 500 to 1000 people so far.

Dr. Shawn Cowper of Yale University estimates the risk of contracting the disease at 5 percent for kidney patients.

To date, there is no known treatment for NSF. The disease can lead to a debilitating hardening of the skin.

For Sarah Fracella, the skin on her hands has hardened so much that she cannot open a bottle on her own. She also has trouble sitting and walking. In more extreme cases, NSF has attacked internal organs. NSF has also proven fatal.

KCRA3 has learned that the Burg Simpson law firm in Denver, Colo., is already investigating dozens of potential lawsuits.

Attorney Peter Burg alleges that GE Healthcare, the manufacturer of OMNISCAN, one of the most widely used gadolinium-based dyes, “knew or should have known that this product was inherently dangerous and ultrahazardous to humans.”

When contacted, GE Healthcare said it does not comment on pending litigation.

As for Fracella, she said she is telling her story as a warning to others. She wants to make sure anyone with weakened kidneys is aware of the risk of this disease before they accept the use of a gadolinium-based dye in their body.

“It’s been the hardest thing I’ve ever had to deal with in my life,” she said.

November 26th, 2007

SOURCE: Gadolinium and NSF › Some kidney patients suffer MRI poisoning

Fracella is one of as many as 1,000 people worldwide who have contracted a debilitating, incurable and sometimes fatal disease called nephrogenic systemic fibrosis, or NSF, from the dye that is used in millions of magnetic resonance imaging scans every year.

For most people, dyes based on gadolinium – the magnetic ion blamed for the condition – are safe, said David Seidenwurm, a neuroradiologist with Radiological Associates of Sacramento. But for people with severe kidney problems, the ion can poison the patient by causing collagen to build up in tissues.

The Food and Drug Administration asked manufacturers in May to include a so-called black-box warning on gadolinium-based products, saying patients with kidney problems could develop NSF after a single exposure. In addition to severe thickening of the skin, leading to immobility, the disease is also known to affect the liver, the lungs and the heart.

Few alternatives to dye for MRIs

The specific cause of NSF is not yet understood, but researchers at Yale University reported that in more than 95 percent of the cases they had surveyed, patients were exposed to a gadolinium-based dye two to three months before the onset of the disease.

Shawn E. Cowper, a dermatologic pathologist at Yale who first identified the condition with Philip LeBoit of the University of California-San Francisco, said as many as 1 in 20 kidney patients could be at risk of contracting NSF after undergoing an MRI using gadolinium.

Gadolinium-based dyes latch into specific tissue types in the body, making them easy to contrast from other tissues on an MRI. The tests can be administered without a contrasting agent, but they are considered to be significantly less useful.

Complicating the problem is that gadolinium is the only contrasting agent approved for use in most MRIs. Two others, Feridex I.V. and Teslascan, are limited to use only in examinations of specific liver problems.

NSF has been confirmed in children and the elderly, but it tends to affect the middle-aged most commonly, according to the International Center for Nephrogenic Fibrosing Dermopathy Research. It affects men and women equally.

The FDA recommended that all patients with serious kidney problems ask their doctors not to use contrasting agents in MRI exams, unless there is no alternative.

‘Hardest thing I’ve ever had to deal with’

Numerous lawsuits have been filed against GE Healthcare, a division of General Electric Co., which manufactures gadodiamide, the type of gadolinium implicated in a large majority of the cases known to date. GE Healthcare said that the company does not comment on pending litigation but that in general, it believes it has “a number of meritorious defenses.”

For Fracella, the skin on her hands has hardened so much that she cannot open a bottle on her own. She also has trouble sitting and walking.

“It’s been the hardest thing I’ve ever had to deal with in my life,” she said.

Fracella’s mother, Susan, said her daughter’s condition was “terrifying.”

“It’s agonizing to watch your child suffer,” she said. “… I mean, knowing this now, would you want any of your children to have an MRI?”

November 8th, 2007

SOURCE: Gadolinium and NSF › Common MRI poisoning some kidney patients

Only about 215 cases have been reported worldwide, all involving people with kidney disease. No cures have been reported but some patients have seen improvement after treatment to improve their kidney function, according to the International Center for Nephrogenic Fibrosing Dermopathy Research.

Gerber’s lawsuit claims that people with impaired kidney function can’t properly eliminate the gadolinium from their system.

Last year, the U.S. Food and Drug Administration issued an advisory that patients with moderate to “end-stage” kidney disease should avoid having medical scans that use gadolinium-based contrast dyes, such as magnetic resonance images and magnetic resonance angiographies. If the imaging is done, “prompt dialysis” following the procedure should be considered, the FDA said.

Gerber had such imaging before he underwent a kidney transplant.

His lawsuit, filed Friday in San Francisco Superior Court, names medical centers and companies involve in making, distributing and using the dyes, including Bayer Healthcare Pharmaceuticals Inc. and GE Healthcare Inc.

Both companies have added warning labels to their dyes.

“Mr. Gerber was never warned that there was any kind of risk associated with gadolinium, let alone NSF,” Gerber’s attorney, Lawrence J. Gornick, told the Los Angeles Daily Journal. “Because of that, he developed a life-threatening disease that will most likely take his life in a horrible way.”

“There is only one identified cause of NSF, and that’s gadolinium,” Gornick said. “And there is only one way gadolinium gets into the human body, and that’s through these contrasting agents.”

Gornick said he expected to seek millions of dollars in damages.

Bayer spokeswoman Marcy Funk said Tuesday that the company could not comment on pending litigation.

“There are warning labels on the product,” she said. “Patient safety is always the No. 1 priority of the company and we’re working with the health authorities … on this particular issue.”

GE Healthcare spokesman Brian McKaig said in a written statement that a “definitive causal relationship” between NSF and the use of gadolium-based dyes has not been established.

“GE Healthcare does not comment about ongoing lawsuits but the company is concerned for patients diagnosed with NSF “and continue to emphasize our commitment to patient care and safety,” he wrote..

Gerber’s is one of only a handful of lawsuits filed by people with the rare disease.

October 30th, 2007

SOURCE: Gadolinium and NSF › NorCal man blames MRI dyes for illness

The FDA’s move on Friday finalizes its announcement in May that it would add the labeling warning to the MRI contrast agents.

The final warning notes that the agent boosts the risk of a potentially fatal side effect in patients with certain kidney and liver conditions. The skin disease called nephrogenic systemic fibrosis, or NSF, can occur in some patients, the companies said in a joint letter to health-care professionals, posted on the FDA’s Web site on Friday.

Such gadolinium-based imaging agents are made by Bayer AG’s Bayer Schering Pharma, General Electric Co’s GE Healthcare, Tyco International Ltd.’s Mallinckrodt unit, and Bracco Diagnostics Inc.

The FDA has said there have been no reports of nephrogenic systemic fibrosis among patients with normal kidney function or those with mild-to-moderate kidney insufficiency.

Agency officials first alerted doctors to the potential risk in 2006, following reports that patients who received the injectable agents developed NSF.

Although the risk of NSF from any one agent is unknown, the letter cited a study that found an estimated risk in patients with severe renal insufficiency at 4 percent.

The condition triggers thickening of the skin, organs and other tissues that makes it difficult to move and can lead to broken bones. There is no effective treatment.

Patients should be screened for kidney problems before use of such agents, the letter said, adding that the recommended dose should not be exceeded.

October 18th, 2007

SOURCE: Gadolinium and NSF › MRI contrast agents get strong kidney-risk warning

Reporting in the October issue of the American Journal of Dermatopathology, the authors suggest a possible explanation for why some patients on kidney dialysis who are injected with a “contrast agent” during a magnetic resonance imaging (MRI) develop nephrogenic systemic fibrosis (NSF).

The U.S. Food and Drug Administration now requires a warning about the potential risk on the products’ labels. NSF leads to thickened, rough or hard skin usually on the arms, legs or trunk. In some cases, the limbs can become difficult or even impossible to move.

“The cause of this syndrome has been unclear,” said David C. Sane, M.D., senior researcher on the project. “Our research suggests both a potential cause and the possibility of preventing or treating NSF.”

Sane said the finding — that an enzyme known as transglutaminase-2 (TG2) may be involved — is the first to suggest how exposure to contrast agents may lead to NSF.

It has not been known what causes NSF, but a risk factor is exposure to gadolinium, an agent injected into patient’s veins during some MRI procedures to help improve the visibility of internal organs during the test. The condition is relatively rare — it occurs in about 2 percent to 4 percent of kidney patients on dialysis who are exposed to gadolinium.

The researchers tested the hypothesis that TG2 may be involved in the response. The enzyme is found throughout the body and is involved in blood clotting and wound healing. They hypothesized that gadolinium may activate the enzyme and cause NSF.

The group obtained skin biopsies from five people with NSF and three healthy people. All NSF patients had renal failure and had previously had imaging procedures using gadolinium. The researchers tested for the presence of TG2 in the skin samples.

“Compared to the healthy subjects, there was a marked increase in TG2 in the subjects with NSF,” said Sane. “This suggests that activation of TG2 can produce the syndrome. TG2 is expressed in virtually all tissues and may explain why the fibrosis can occur in the heart and lungs, as well as the skin.”

Sane said the results also suggest a strategy for preventing or treating NSF — drugs such as cysteamine that inhibit the activation of TG-2.

“Our research is a pilot study, but we believe the results warrant further research into the use of TG-2 inhibitors in the treatment and prevention of NSF,” said Gil Yosipovitch, M.D., co-senior researcher, and a dermatologist. “Solving this puzzle might allow dialysis patients to take full advantage of the diagnostic capabilities of MRI.”

“This could be a general mechanism for a broad range of disorders that involve fibrosis, or tissue thickening,” said Sane.

Other researchers were lead investigator Amy Parsons, M.D., Daniel Sheehan, M.D., and Omar P. Sangueza, M.D., all from Wake Forest’s Department of Pathology, and Charles S. Greenberg, M.D., with Duke University.

October 17th, 2007

SOURCE: Gadolinium and NSF › Cause of debilitating skin condition suggested