Recent research has raised serious concern about the safety of Omniscan and other gadolinium-based MRI contrast dyes. This research suggests that the agents may leave behind toxic gadolinium deposits in the brain, which could potentially result in a significant decline in cognition or thought processes.
If you underwent an MRI with Omniscan or another gadolinium-based contrast dye and believe that the agent caused you harm, contact RLG immediately for a free, confidential Omniscan lawsuit consultation. We will evaluate your case for free and do all that is necessary to help you obtain fair compensation for the harm you’ve suffered.
What is Omniscan and What is it Used For?
Omniscan and other gadolinium-based contrast dyes are used in magnetic resonance imaging (MRI) to help doctors view the brain, spine, chest, stomach, hip area, and other parts of the body. Omniscan was approved by the U.S. Food & Drug Administration (FDA) in January 1993, and is marketed by GE Healthcare. Other gadolinium MRI contrast dyes currently on the market include:
It is estimated that gadolinium-based dyes like Omniscan are used in 30% of all MRIs, making these products the most frequently utilized MRI agents.
Gadolinium is a rare-metal earth that is classified as a paramagnetic metal ion. Paramagnetic metal ions move differently within a magnetic field, which makes gadolinium useful in an MRI. The first gadolinium contrast agent was approved for use in MRI by the FDA in 1988.Gadolinum-based contrast agents are also used for magnetic resonance angiography (MRA), an imaging procedure used to evaluate blood vessels. However, the FDA has not approved gadolinium dyes for use in MRA.
Gadolinium-based contrast dyes are mostly eliminated from the body through the kidneys, though trace amounts of the material can remain for the long-term. In 2006, the FDA warned that these products had been associated with a debilitating disease called nephrogenic systemic fibrosis (NSF) when administered to patients with acute or chronic severe renal (kidney) insufficiency. In 2007, the agency ordered the manufacturers of gadolinium-based contrast dyes to include a boxed warning regarding the potential for NSF on their product labels. The agency has cautioned that patients with reduced renal function or chronic or acute kidney failure should not be exposed to gadolinium-based MRI agents.
Omniscan May Harm the Brain
In July 2015, the FDA issued a Drug Safety Communication announcing that it was again reviewing the safety of gadolinium contrast dyes, after a number of studies reported gadolinium deposits in the brains of patients who had undergone four or more MRIs with these agents. Among other things, the studies confirmed that gadolinium can remain in the brain even in individuals with normal kidney function
The FDA is currently working with the National Center for Toxicological Research (NCTR) to determine whether these gadolinium deposits are harmful or can lead to adverse health effects. While it completes its review, the FDA has advised health care providers to consider limiting the use of Omniscan and other gadolinium-based contrast agents to clinical circumstances in which the additional information provided by the contrast is necessary. They have also been urged to reassess the necessity of repetitive gadolinium MRIs. The FDA did not announce an Omniscan recall or a recall of any other gadolinium-based MRI contrast agent dye. So far, the agency has not required manufacturers to make any related changes to the labeling of their gadolinium contrast agent products.
RLG’s Lawyers Will Make Things Easier
Taking GE Healthcare or any other pharmaceutical company to court to obtain compensation for the harm you’ve suffered is a complicated and intimidating process. The Omniscan lawyers at the Rottenstein Law Group believe that the victims of dangerous medical products shouldn’t have to endure more hardship in order to be made whole again. That’s why we do everything we can to simplify the legal process, including filing an Omniscan lawsuit on your behalf if necessary.
If you believe that Omniscan or another gadolinium-based contrast agent caused you harm, contact RLG today 1 (888) 976-8529.