Gadolinium Lawyer

Gadolinium blamed for illness

admin — Wed, 31 Oct 2007 21:59:19 +0000

An elderly man in Northern California has sued various health companies after he contracted an incurable disease due to the dyes used in an MRI.

Around 215 cases of gadolinium causing nephrogenic systemic fibrosis or nephrogenic fibrosing demopathy have been reported worldwide. No cures have been found but some patients see improvement in their condition after treatments.

The FDA issued an warning to kidney disease patients, advising them to avoid medical scans that use gadolinium based contrast agents.

Peter Gerber, the man suing the health companies, calims to have never been informed of the potential dangers of gadolinium. Other similar lawsuits have been filed in Florida and Ohio.

To learn more contact the Gadolinium Lawyers at Williams Kherkher by calling 1-800-220-9341.

Gadolinium Based Agents pose even greater risk when used in MRA

admin — Wed, 31 Oct 2007 21:43:45 +0000

Gadolinium based contrast agents that are used in MRIs have been linked with Nephrogenic Systemic Fibrosis(NSF)/Nephrogenic Fibrosing Dermopathy (NFD) in patients with kidney disease. Recently, the FDA released information that suggests MRAs, a variation of MRIs, that use gadolinium based contrast agents may pose more of a risk of causing NSF than they do in traditional MRIs.

MRAs provide information that isn’t given in an ultrasound, X-ray or CT scan. Although this infomation is important in detecting aneurysms, blood clots, and plaquw buildup in blood, the dangers of gadolinium based contrast agents can’t be ignored.

In order to be effective in an MRA, three times the approved amount of gadolinium must be injected before the MRA takes place. This amount of gadolinium can easily cause cases of NSF and NSD.

For more information contact the Gadolinium Lawyers at Williams Kherkher by calling 1-800-220-9341.

FDA Warning on Gadolinium-based Agents

admin — Mon, 29 Oct 2007 14:58:02 +0000

As of May 23, 2007 the U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).Warnings would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition.

Patients should be screened for kidney problems prior to receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again. There have been no reports of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency.

Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. The reports have not always identified a specific agent however; Omniscan was the most commonly reported agent.

To learn more, please contact Gadolinium Lawsuit Lawyers at Williams Kherkher by calling 1.800.220.9341.

Warning Letter from Manufacturer

admin — Tue, 16 Oct 2007 19:57:27 +0000

Manufacturers of Gadolinium-based contrast agents issued a Dear Healthcare Professional letter to inform healthcare professionals of the addition of a BOXED WARNING and revisions to the WARNING section of the prescribing information for Gadolinium-based contrast agents used in Magnetic Resonance Imaging (MRI).The text of the letter is as follows:Dear Healthcare Professional,
The manufacturers of gadolinium-based contrast agents would like to inform you of important revisions to the prescribing information for the products listed in alphabetical order above. Gadolinium-based contrast agents are approved by the U.S. Food and Drug Administration (FDA) for use in magnetic resonance imaging (MRI).Post-marketing reports show that the use of these agents increases the risk of the development of a serious medical condition called Nephrogenic Systemic Fibrosis (NSF), in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2) and patients with renal dysfunction due to the hepatorenal syndrome or in the perioperative liver transplantation period.NSF leads to excessive formation of connective tissue in the skin and internal organs. NSF is progressive and may be debilitating or fatal. As of today, the FDA has received reports of over 250 cases of NSF after administration of gadolinium-based contrast agents.As a result of these NSF cases, the package inserts of all gadolinium-based contrast agents have been revised to include the following Boxed Warning and update to the WARNINGS section.

Call 1-800-FDA-1088 (1-800-332-1088)

For more information, contact Gadolinium Lawyers at Williams Kherkher by calling 1.800.220.9341.

History of Gadolinium

admin — Tue, 16 Oct 2007 19:54:01 +0000

Gadolinium (chemical symbol “Gd”) is a chemical element listed on the Periodic Table. It was named after the Finnish chemist John Gadolin (1760-1852) to honor his research in rare earth metals. Gadolinium is a silvery-white rare metal which occurs naturally on Earth and is relatively stable in dry air unlike other s of that classification. It is not found in nature in its free form, but is contained in rare minerals and must be chemically extracted. It cost $130.00 per kilogram in 2005.In addition to its use as an intravenous radiocontrast agent given to patients undergoing an MRI, it is used to manufacture or produce components used in mircrowave applications, TV tubes, compact discs, computer memory and as a burnable poison in nuclear marine propulsion systems.

Its paramagnetic properties make it useful for other imaging besides MRI’s, such as X-rays ,PET scans and a bone density gauge for osteoporosis screening, although Gadolinium is ingested only for MRI applications. Gadolinium compounds, as with other chemical elements in its class of “lanthanides,” are of low to moderate toxicity. Nephrogenic Systemic Fibrosis (NSF) was first described in medical literature in 2000 in patients with purportedly moderate renal insufficiency. The association between NSF and Gadolinium-based contrast agents was first reported in Danish Medicines Press release issued on May 29, 2006.

For more information, contact Gadolinium Lawyers at Williams Kherkher at 1.800.220.9341.

admin — Mon, 15 Oct 2007 20:51:45 +0000

How will my doctor know if I am suseptible to NSF before using gadolinium in an MRI?

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Unless you to your physician, he or she will not know so it’s important to communicate if you have any kidney problems before having an MRI. To learn more, contact a Gadolinium Lawyer at Williams Kherkher.

admin — Mon, 15 Oct 2007 20:50:05 +0000

Is there a safer alternative contrast agent that can be used in MRI studies?

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No, at present, Gadolinium is the agent being used. To learn more, call the Gadolinium Lawyers at Williams Kherkher.

Research on NSF

admin — Mon, 15 Oct 2007 19:11:34 +0000

Reporting in the October issue of the American Journal of Dermatopathology, Researchers at Wake Forest University, Baptist Medical Center 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). a rare tightening and swelling of the skin and other organs, including the lungs and heart

The researchers tested the hypothesis that TG2, an enzyme known as transglutaminase-2, 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.”

“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.”

To learn more, contact a Gadolinium Attorney at Williams Kherkher by calling 1.800.220.9341.

Gadolinium-based Contrast Agents

admin — Mon, 15 Oct 2007 14:45:19 +0000

The U.S. Food and Drug Administration (FDA) first notified health care professionals and the public about the gadolinium-related risks for NSF in June 2006 and updated the information in December.When patients undergo an MRI, gadolinium-based contrast agents are commonly used to improve the visibility of internal structures. Five gadolinium-based contrast agents have been approved for use in the

United States: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol).

According to reports, the development of NSF can follow a single and or multiple administrations of the gadolinium-based contrast agents. The reports have not always identified a specific agent. The most commonly reported agent was Omniscan, when a specific agent was identified, followed by Magnevist and OptiMARK. NSF has also developed after the sequential administration of Omniscan and MultiHance and Omniscan and ProHance. Because reports do not completely describe exposure to gadolinium-based contrast agents, it is not possible to know if the extent of risks for developing NSF is the same for all agents. Patients should be screened for kidney problems prior to receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again.No cases have been reported of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency. To learn more, please contact a Gadolinium Lawyer at Williams Kherkher by calling 1.800.220.9341.

Gadolinium link to NSF

admin — Mon, 15 Oct 2007 14:42:38 +0000

The U.S. Food and Drug Administration (FDA) have asked manufacturers of all gadolinium-based contrast agents to include a new boxed warning on the product labeling. These agents are used to enhance the quality of magnetic resonance imaging (MRI).The warning states that patients with severe kidney insufficiency are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF) if they receive gadolinium-based agents. In addition, the warning would also state that another group of patients at risk for developing NSF as those patients with chronic liver disease and patients just before or just after liver transplantation. “FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease,” said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. “This latest action demonstrates FDA’s continuing vigilance about ensuring the safety of drug products once they enter the marketplace.” Patients with NSF develop thickening of the connective tissues and skin and that inhibits their ability to move and may result in broken bones. Other organs are also at risk of thickening. The cause of NSF is not known and there is no consistently effective treatment for this condition.

To learn more, contact the Gadolinium lawyers at Williams Kherkher by calling 1.800.220.9341.