MRI Contrast Dye Lawsuits | Howard L. Nations National Pharmaceutical Law Firm

Last updated September 12, 2007

GADOLINIUM RESEARCH & WARNINGS

Research shows that gadolinium can trigger NSF or NFD in people with kidney impairment
In June of 2006, the FDA issued their first public warning about the risks of gadolinium
In May of 2007, the FDA ordered a black box warning for all gadolinium dye labels
The black box warning recommends avoiding gadolinium dyes unless absolutely necessary

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People are going in for MRI or MRA procedures and ending up with nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD), a debilitating and potentially fatal disease for which there is no cure. Certain people are at risk for developing NSF if they are exposed to gadolinium. Gadolinium is the active ingredient in contrast dyes often injected into the bloodstream during MRI and MRA exams. Until recently, doctors and patients were not warned about this life-threatening risk.

GADOLINIUM RESEARCH

Many studies have linked gadolinium-based contrast agents (GBCAs) to the development of NSF among some patients. Following is an excerpt from the FDA's Questions & Answers and a list of some of the recently published research:

Together, accumulating data indicate that GBCAs increase the risk for the development of NSF among patients with severe renal insufficiency or renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period.

April 2006: Case report published in Nephrology Dialysis Transplantation medical journal regarding a possible link between GBCAs and NSF. Advance Access - January 23, 2006. (Grobner et al, Nephrol Dial Transplant 2006; Vol 21 (4):1104 1108. Erratum 2006 Jun;21(6):1745.)

May 29, 2006: Press release from the Danish Medicines Agency (DMA) about 25 reported cases of NSF among patients who had been exposed to Omniscan, a gadolinium contrast dye.

August 2, 2006: Study results published in the Journal of American Society of Nephrology found that gadolinium dye Omniscan triggers NSF. Retrospective study of about 370 patients with severe renal insufficiency using Omniscan estimated the risk of NSF to be 4%. (Marckmann et al, J Am Soc Nephrol 2006; 17: 2359 2362.)

November 13, 2006 (online) & January 2007 (print): Case study published in the Journal of the American Academy of Dermatology finds gadolinium in the tissue of NSF patients. (High et al, J Am Acad Dermatol 2007; 56 (1): 21 26.)

February 7, 2007: Study results published in the Clinical Journal of the American Society of Nephrology showed that exposure to GBCAs created a "highly significant" risk for NSF in patients with end-stage renal disease. (Deo et al, Clin J Am Soc Nephrol 2: 264 267, 2007.)

February 12, 2007 (online) & April 2007 (print): Research Letter published in the Journal of the American Academy of Dermatology shares study results linking gadolinium to NSF. (High et al, J Am Acad Dermatol 2007; 56 (4): 710-712.)

February 23, 2007: Study results published in the Morbidity and Mortality Weekly Report of the Center for Disease Control (CDC) showed that exposure to GBCAs was independently associated with nephrogenic fibrosing dermopathy (NFD). (MMWR 2007; 56(07):137 141.)

This is only a small sampling of the published research showing a clear link between gadolinium dyes and NSF or NFD. If you or someone you know has developed NSF or NFD symptoms after being exposed to an MRI or MRA contrast dye, contact our offices for a free case evaluation by one of our pharmaceutical attorneys.

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FDA WARNINGS

June 8, 2006: First Public Health Advisory issued by the FDA about the risk of NSF from gadolinium dyes. This was after they received reports of 25 patients with NSF from the Danish health authority.

December 22, 2006: Second Public Health Advisory issued by the FDA with updated information.

The FDA released information that patients with moderate renal insufficiency were at risk of developing NSF. It turns out that this was a mistake. These patients only appear to be at risk if they also have liver transplantation or chronic liver disease. There have been no reports of NSF in patients with normal renal functioning.

May 23, 2007: The FDA ordered that a black box warning and other warnings be added to all GBCA labels about the life-threatening risks associated with GBCA use. Detailed information was provided to healthcare providers in the Information for Healthcare Professionals. Following are excerpts from the FDA Press Release:

The requested warning would state that patients with severe kidney insufficiency who receive gadolinium based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity. ...

Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. ... Omniscan was the most commonly reported agent, when a specific agent was identified, followed by Magnevist and OptiMARK.

...Because reports incompletely 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.

Text of Black Box Warning:

Exposure to GBCAs increases the risk for NSF in patients with:
acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m2), or

acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

NSF is a debilitating and sometimes fatal disease affecting the skin, muscle, and internal organs.

Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI).

Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests.

When administering a GBCA, do not exceed the dose recommended in product labeling. Allow sufficient time for elimination of the GBCA prior to any readministration.

For many people, these warnings came too late. If you or someone you know has developed NSF or NFD symptoms after having an MRI or MRA, contact our firm for a free case evaluation by one of our experienced pharmaceutical attorneys.

Our firm represents people across the country who have been injured by gadolinium contrast dyes. We have the experience, the resources, and the dedication to fight for the rights of patients unjustly injured by dangerous drugs.

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