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NSF / NFD Associated with Gadolinium Based Contrast Agents More Common and Deadly than Previously Thought
Oct 17, 2007 | Parker Waichman Alonso LLP
Nephrogenic Systemic Fibrosis / Nephrogenic Fibrosing Dermopathy (NSF/NFD), a painful conditions that has been linked to the use of gadolinium based contrast agents used in Magnetic Resonance Imaging (MRI), could be more prevalent than once thought. A recently released study also found that kidney patients with NSF/NFD are far more likely to die than those without the disorder.NSF/NFD, a disease that affects people with pre-existing kidney disease, 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/NFD can progress to the point of causing severe stiffness in joints, and it can lead to death.
A new study conducted by researchers at Massachusetts General Hospital has confirmed suspicions that the onset of NSF/NFD is strongly associated with gadolinium based contrast agents. The study, which was published in the October issue of the Journal of Arthritis & Rheumatism, found that kidney patients who had undergone MRIs with gadolinium based contrast agents were 10 times more likely to develop NSF/NFD than patient who had not been exposed to such agents. The investigators also found that 48% percent of the NSF/NFD patients in the study died only two years after being examined by researchers at Massachusetts General Hospital. Among the study participants without NSF/NFD, only 20% died during the same period.
For several years now, gadolinium based contrast agents have been a prime suspect in the sudden appearance of NSF/NFD. The first case of NSF/NFD was not even reported in 1997, and it wasn’t mentioned in medical literature until 2000. In 2006, Dutch researchers first linked gadolinium contrast agents to the onset of NSF/NFD. That same year, the FDA warned health care professionals about the link between gadolinium contrast agents and the occurrence of NSF/NFD. Then in 2007, the FDA requested that that the manufacturers of gadolinium based contrast agents update their products’ labels to include a black box warning regarding the risk of NSF/NFD in patients with kidney problems. The FDA also started a monitoring program to track the frequency of NSF/NFD related to gadolinium contrast agents.
The research done at Massachusetts General Hospital only serves to underscore the danger that gadolinium based contrast agents pose to people with kidney problems. The investigators who conducted this study noted that patients who are scheduled for MRIs that involve the use of gadolinium based contrast agents should always be screened for underlying kidney problems, and those with pre-existing kidney disease should never be exposed to gadolinium.
Gadolinium MRI/MRA Contrast Dye
