Omniscan is the brand name of a gadolinium based MRI contrast agent manufactured by GE Healthcare. It is one of five MRI contrast agents using gadolinium that are approved for use in the United States. Omniscan was introduced in 1993 and is used by doctors in order to enhance MRI images of tissue abnormalities, such as tumors. In most patients, gadolinium passes through the body in a relatively short time. However, patients with kidney conditions may be unable to eliminate the gadolinium, which puts them at risk for developing a serious and potentially fatal health condition.
No warnings were given that Omniscan put kidney patients in danger until June 6, 2006, when GE Healthcare issued a safety advisory for Omniscan. This safety advisory warned physicians that the use of the Omniscan contrast agent in an MRI or MRA on a patient with pre-existing renal (kidney) issues may lead to that patient developing Nephrogenic Systemic Fibrosis (NSF) / Nephrogenic Fibrosing Dermopathy (NFD). NSF / NFD is a serious condition that may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.
GE Healthcare has been advised of 96 cases of NSF / NFD following use of MRI contrast agents such as Omniscan in the United States, Europe and Asia. In addition, several gadolinium lawsuits have been directed at GE Healthcare as a result of NSF caused by gadolinium. In one case, Greta Carolus filed a suit in the U.S. District Court against General Electric Company, GE Healthcare, Inc., and GE Healthcare Bio-Sciences Corporation alleging that she developed NSF just days after getting an MRI that used Omniscan as a contrast agent. The FDA has issued its strongest warning for gadolinium MRI injections because of the serious symptoms linked to the drug.
Gadolinium contrast dyes, such as Omniscan, put kidney patients at an even higher risk of developing NSF when used during an MRA. An MRA is a type of MRI that is used to provide pictures of the body's blood vessels. Gadolinium based MRI contrast agents are often used to enhance MRA images. The use of gadolinium based MRI contrast agents for MRAs is an off-label use that has never been approved by the FDA. For Omniscan to be effective in an MRA, it must be administered at three times the approved dose. If a person's kidneys are not functioning properly, it is extremely unlikely that so much gadolinium will be eliminated from the body. As a result, the chances that the patient will develop NSF are increased.
If you or a loved one underwent an MRI or MRA and the gadolinium contrast dye Omniscan was used, you may be at risk for developing NSF or NFD. A number of lawsuits due to gadolinium exposure have already been filed to recover for damages. Contact Morgan and Morgan's Gadolinium Lawyers today for a free consultation and information about your legal rights.
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