Gadolinium, a contrast agent used in MRI scans, is the target of a new health warning issued for patients and healthcare providers.
The warnings are being added to the medication guide and patient materials for certain MRI, or magnetic resonance imaging tests. Top officials at Bayer, GE, Bracco Diagnostics and Guerbet signed off on the warning. All four companies manufacture MRI machines that use gadolinium.
Experts are concerned about possible metal poisoning from gadolinium, which is used as a contrast agent in thousands of MRIs every year. A growing number of lawsuits — including one filed on behalf of the wife of martial arts star Chuck Norris — claim the chemical can lead to severe pain, burning, loss of balance and other signs of metal toxicity.
Gadolinium Lawsuit Claims
McKesson Corp. is one of several defendants in the gadolinium lawsuits. Gena Norris, the wife of actor Chuck Norris, alleges the chemical was injected in her body as part of MRI scans. Her lawsuit claims gadolinium settled in her tissue and bones, causing harm from metal toxicity. Investigators at the U.S. Food and Drug Administration are looking into the possible link between gadolinium-based contrast agents and injuries to MRI patients.
New Warning Details
The new warning issued in May 2018 includes the following details:
“Pathologic and clinical consequences of GBCA (gadolinium based contrast agent) administration and retention in skin and other organs have been established in patients with impaired renal function. There are rare reports of pathologic skin changes in patients with normal renal function. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.”
“While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible.”
MRI tests that may use gadolinium include Eovist, Gadavist, Magnevist, MultiHance, ProHance, Omniscan, Dotarem, and Optimark. The lawyers at Jones Ward PLC offer a free, no-obligation evaluation of your potential lawsuit. Our team handles a wide variety of drug and product liability cases. Fill out the form located here, or call us toll-free at 888-595-2922 for a free evaluation of your potential lawsuit.