Gadolinium Lawsuit
People that have been injected with Gadolinium based contrast agents used in MRI and MRA procedures have filed lawsuits claiming that it causes NSF or NSD and that the defendants’ warnings were inadequate.
Starting in June of 2006, the Food and Drug Administration started to notify healthcare professionals and the public about the possible risk of developing NSF following exposure to Gadolinium based contrast agents after it received reports from the Danish Health Authority of 25 patients who had developed the disease.
Since then, the FDA has requested the manufactuers of these contrast agents to revise their product labels and include new boxed warnings describing the risk of NSF and NSD.
The following is an excerpt from the FDA’s website showing the boxed warning and additional new warnings:
Boxed Warning
Exposure to GBCAs increases the risk for NSF in patients with:
• acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
• acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
NSF is a debilitating and sometimes fatal disease affecting the skin, muscle, and internal organs.
Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI).
Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests.
When administering a GBCA, do not exceed the dose recommended in product labeling. Allow sufficient time for elimination of the GBCA prior to any readministration.
Additional New Warnings:
Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA.
For patients receiving hemodialysis, healthcare professionals may consider prompt hemodialysis following GBCA administration in order to enhance the contrast agent’s elimination. However, it is unknown if hemodialysis prevents NSF.
Determine the renal function of patients by obtaining a medical history or conducting laboratory tests that measure renal function prior to using a GBCA.
The risk, if any, for developing NSF among patients with mild to moderate renal insufficiency or normal renal function is unknown.
Post-marketing reports have identified the development of NSF following single and multiple administrations of GBCAs. These reports have not always identified a specific agent. Where a specific agent was identified, the most commonly reported agent was Omniscan, followed by Magnevist and OptiMARK. NSF has also developed following the sequential administration of Omniscan and MultiHance and Omniscan and ProHance. The distribution of the number of reports for the individual GBCAs may relate to multiple factors, including more limited use of some GBCAs, under-reporting of NSF, characteristics of the agent and a lack of patients’ complete GBCA exposure history.
Our law firm is helping people who are suffering side effects associated with Gadolinium based contrast agents. We represent clients nationwide on a contingency fee basis, which means there are no legal fees unless we make a recovery for you. Call us today for a free, no obligation consultation. 1-866-777-2557, or use our online contact form and an MRI Side Effects Attorney will contact you.