But the use of gadolinium in a procedure call Magnetic Resonance Angiography (MRA) could put these patients at an even greater risk of developing NSF/NSD, because these procedures often use far more gadolinium than a typical MRI. The use of gadolinium contrast agents in MRAs is a growing practice, even though the Food Drug Administration (FDA) never approved gadolinium for MRAs.

An MRA is a variation of a traditional MRI that is used to provide pictures of blood vessels inside the body. In many cases, an MRA can provide information that cannot be obtained from an X-ray, ultrasound, or computed tomography (CT) scan. An MRA is often used to detect aneurysms, blood clots or narrowing caused by plaque buildup in the blood vessels leading to the brain, and it is also used to find similar narrowing in the vessels leading to the lungs, kidneys and legs.

Currently, five gadolinium based contrast agents are approved for use by the FDA. These are Omniscan, Optimark, Magnevist, Multihance and Prohance. Gadolinium contrast agents are used during MRAs for the same reason they are used in MRIs, to help differentiate between normal and abnormal tissue. The gadolinium based contrast agent is injected into the bloodstream right before an individual undergoes an MRA. However, in order to be effective in an MRA, the gadolinium contrast agent must be administered at three times the approved dose. What’s more, this constitutes an off-label use of gadolinium based contrast agents – that is these agents were never approved by the FDA to be used with MRAs.

In 2006, evidence began to emerge that gadolinium based MRI contrast agents were linked to the development of NSF/NSD. NSF/NSD is a debilitating disease that affects people with pre-existing kidney disease. The first case of NSF/NSD was reported in 1997, and it wasn’t mentioned in medical literature until 2000.

NSF/NSD 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/NSD can progress to the point of causing severe stiffness in joints, and it can lead to death. Unfortunately, for many patients with NSF/NSD, the only way to improve kidney function is with a transplant.

October 31st, 2007

SOURCE: Gadolinium and NSF › Gadolinium contrast agents used off-label in MRAs pose even greater risk

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

There are five different types of gadolinium based contrast agents, and the FDA has evidence enough to suggest a causal connection between the agents and a skin condition called nephrogenic systemic fibrosis (NSF) in patients with impaired kidney function.

NSF normally begins from days to several months after the exposure to the contrast agents, and results in the thickening and tightening of the skin. Skin may become spotted and may be accompanied by a burning/itching sensation. Joint stiffness is also part of NSF, which leads to trouble moving the arms and legs.

Reports of reactions to gadolinium based contrast agents first surfaced in 2006 when cases of nephrogenic systemic fibrosis developed in patients with renal insufficiency.

The rate of treated patients with impaired kidney function developing NSF was found to be 4% of the population.

October 18th, 2007

SOURCE: Gadolinium and NSF › MRI Gadolinium contrast agents get black box warning