When a doctor orders a magnetic resonance imaging (MRI) of the liver, he usually also requests "contrast," which means the injection of certain chemical agents that will improve the image created by the procedure. Several of these agents contain gadolinium, a toxic rare-earth element that is rendered temporarily safe for use through chelation (binding with safe ingredients). Gadolinium contrast agents are administered through injection. They were first approved for use by the Food and Drug Administration in 1988. As of 2009, there are five gadolinium-based contrast agents approved for use, all of which carry some safety risks for certain patients.
MRIs are performed for the diagnosis of conditions and disease.
FDA Warning
In 2007, the Food and Drug Administration recommended that gadolinium-based contrast agent manufacturers add a risk warning to their packaging. The statement must include the information that the use of the agent causes a risk of NSF, "nephrogenic systemic fibrosis" or "nephrogenic fibrosing dermopathy" (NFD). The first cases were diagnosed in 1997.
Risk Factors
The body eliminates gadolinium through the kidneys. For this reason, the use of gadolinium in an MRI procedure poses a risk of NSF or NFD for those already undergoing dialysis for the treatment of kidney disease of for those already undergoing liver transplants or who are suffering from chronic liver disease.
Symptoms
Signs and symptoms of NSF include swelling in the legs, abdomen and extremities; a burning or itching sensation; yellowing of the eyes; discoloration and thickening or tightening of the skin; and/or pain in the joints, hips and ribs. The symptoms may begin to appear anywhere from several days to several months following the procedure. They may result in limited, painful movement as well as muscle weakness and scarring of the body's internal organs.
Prevalence
There have been more than 200 cases of NSF or NFD attributed to the use of gadolinium over the past ten years. Some cases may not have been properly diagnosed. The risk of contracting these diseases in those with kidney or liver problems and undergoing an MRI with gadolinium contrast are about 4 in 100. The disease can result in permanent disability and/or death.
Screening
Patients undergoing an MRI with contrast should be screened for kidney or liver problems before the procedure. MRI technicians should never exceed the recommended dosage of the contrast agent, and ensure that it has been completely eliminated from the body before being used again.
Litigation
In May 2010, the case of Bullock v. GE will be heard in federal district court in Cleveland. This is a multi-district class-action lawsuit on the subject of product liability for gadolinium-based MRI contrast agents. There have been many other civil lawsuits filed against manufacturers who allegedly distributed these agents knowing of the health risks.
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