A lawsuit was recently filed in US District Court by a former nurse charging that Omniscan was responsible for causing her to develop a serious skin and joint condition called Nephrogenic Systemic Fibrosis. This may be the first lawsuit filed against GE Healthcare, the manufacturer of Omniscan, as a result of adverse events related to the contrast agent. Omniscan, also known as Gadodiamide, is a Gadolinium based contrast agent used to enhance MRI images. The agent is injected into the patient immediately prior to an MRI or MRA procedure to help physicians distinguish blood vessels from tissue.
The lawsuit alleges that days after receiving an injection of Omniscan, the individual developed the signature symptoms of Nephrogenic Systemic Fibrosis which, in turn, developed into extensive fibrosis of the arms, legs, and associated joints. The advancement of the condition has caused numerous effects that may be permanent and could ultimately lead to her death. The individual is now wheelchair bound and is unable to move her legs, several fingers, and her elbows beyond a slight bending and extension. Because of her condition, the individual is no longer able to work as a registered nurse.
The US Food and Drug Administration has received numerous reports of individuals developing Nephrogenic Systemic Fibrosis in recent years. In 2006, the number of reports received and confirmed prompted the US Food and Drug Administration to issue a Public Health Advisory Alert detailing the facts behind patients developing this serious, life-threatening condition after exposure to Gadolinium based contrast agents, such as Omniscan. Since then, much information has been released publicly detailing the link between Gadolinium based contrast agents and the development of Nephrogenic Systemic Fibrosis.
Nephrogenic Systemic Fibrosis has been found to only affect patients with moderate to end stage kidney disease and kidney failure who receive an injection of a Gadolinium based contrast agent prior to an MRI. The condition is considered a fibrosing disorder and can affect the skin, heart, lungs, diaphragm, liver, and skeletal muscles. The skin of the patient’s extremities begins to develop dark or reddened patches that start to tighten and harden, causing the patient extreme discomfort. The tightened skin restricts the movement of the joints and eventually causes the patient to lose their mobility.
Nephrogenic Systemic Fibrosis is considered a debilitating condition and may ultimately be fatal to the affected patient. The Centers For Disease Control concluded in its report that the use of Gadolinium based contrast agents should be avoided in patients with advanced renal failure. Other health agencies have also released reports saying that the use of Gadolinium based contrast agents for MRI imaging should be avoided if the patient has moderate to end-stage kidney disease.