In 2006, a report was released detailing a rare condition affecting a small number of individuals suffering from kidney damage and kidney failure. The condition was called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) and was considered potentially life threatening. All of the patients detailed in the report had received a Gadolinium based contrast agent during an MRI procedure in the weeks and months before the onset of the condition. The condition affects patients with significant renal failure and is considered extremely rare, with less than 300 cases confirmed worldwide.
The first reports of NSF/NFD found in medical literature were written in 2000. The relative newness of the condition means that very little is known about the condition. NSF/NFD is characterized areas of skin that thicken and tighten while the connective tissue underneath begins to calcify. The condition can be extremely painful and results in very limited movement and joint pain. Some patients suffering from NSF/NFD lose the ability to walk. The thickening of the skin restricts joint movement and can eventually become so tight that the attempt to move portions of the body affected by the condition can result in broken bones. The condition can also cause the thickening and scarring of the internal organs of the patient.
NSF/NFD is considered a progressive disease and could be fatal for the patient afflicted. There is no known cure for NSF/NFD. There are many treatment options available to alleviate the symptoms of the condition, but their success is limited. The best treatment for NSF/NFD is to arrest or improve the renal function of the patient, which has been shown to slowly reverse the effects of the condition. Topical medications can reduce the redness and inflammation of the condition and oral steroids may be prescribed as an anti-inflammatory agent.
Whether the Gadolinium based contrast agent administered during the MRI was the cause of the cases of NSF/NFD is unknown, but the information available was enough for the US Food and Drug Administration (FDA) to issue a warning to the healthcare community advising of a possible link. Typically, the patients who develop a case of NSF/NFD have complicated medical histories and it is difficult for researchers to determine conclusively that a Gadolinium based contrast agent was responsible for the development of NSF/NFD. The FDA’s investigation continues as more information is discovered.
There are five Gadolinium based contrast agents that are approved by the FDA for use in MRI procedures. The most common severe side effect associated with the solutions is allergic reaction, which can become life-threatening very quickly. Although over 3000 individuals participated in the clinical studies prior to the release of the Gadolinium based contrast agents, very few of these patients had renal failure or advanced kidney disease. Because the solution is removed from the body by the kidneys, it is reasonable to believe that if the kidneys are not working properly, then the Gadolinium based contrast agent is not being removed from the body efficiently and that can cause serious problems.