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MRI-NSF Association Should Have Been Disclosed Sooner
(March 15, 2008)
Gadolinium contrast agents have been linked to the development of nephrogenic systemic fibrosis (NSF) in individuals with kidney disease. If the manufacturers of these contrast agents had properly conducted studies of their product or analyzed reports or other clinical data, they could have warned earlier about the potential problems. Earlier warnings may have prevented the disabling and painful condition experienced by hundreds, or potentially thousands, of individuals.
Gadolinium is highly toxic and is used as a contrast agent because it is drawn to magnetic fields. When injected before an MRI or MRA, the contrast allows the physician to differentiate blood vessels from nearby tissue when interpreting the exam.
The contrast agent is administered as a chelate, which is supposed to protect the body from the toxic gadolinium. However, individuals with kidney disease may not eliminate the contrast from their body, and defects in the design of some of the contrast agents could allow the gadolinium to separate from its chelate, causing NSF.
WARNINGS ABOUT MRI PROBLEMS
The first written accounts of individuals with kidney problems experiencing a hardening and thickening of their skin following a MRI were published in medical literature in 2000. However, reports indicate that the condition was observed by some doctors as early as 1997.
It was not until 2006 that the first warnings were issued about problems with the MRI contrast agents. In 2006, the FDA warned that physicians should carefully assess the need for gadolinium contrast in patients with moderate to end stage renal disease due to the risk of NSF. In May 2007, a prominent black box warning was added to the contrast agents, indicating that NSF could result for those with kidney disease.
Since the information about potential problems was released, independent researchers and physicians have been able to evaluate the risk and come up with steps to reduce the chances of NSF developing. In July 2007, the American College of Radiology added information to their guidelines on MRI safety about the problems and recommended steps that could be taken to reduce the risk of nephrogenic systemic fibrosis if MRI is needed for someone with kidney problems.
The companies which make the MRI contrast agents should have designed their products to ensure that the toxic gadolinium is not released into the patient’s body. In addition, they should have conducted research on the impact their product would have on those with kidney insufficiencies and warn about the potential problems.
MRI CONTRAST LAWYERS
The lawyers at Davis & Crump are pursuing NSF claims and filing lawsuits throughout the United States. Symptoms of NSF could include dark patches, burning, itching, swelling, hardening or tightening of the skin, which usually develops on the arms, hands, legs or feet. If you or a loved one feel you may have NSF, contact the attorneys at Davis & Crump at 1-800-277-0300.
Contact Us
Davis & Crump is now handling claims for individuals who have been diagnosed with Nephrogenic Systemic Fibrosis (NSF) or Nephronic Fibrosing Dermopathy (NFD). Davis & Crump is experienced in pharmaceutical product liability cases and settlements. If you or a loved one has suffered Nephrogenic Systemic Fibrosis (NSF) or Nephronic Fibrosing Dermopathy (NFD), please contact us at 1-800-277-0300, or send us an email at info@daviscrump.com.
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