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