Ohio Medical Device Attorney: Studies Indicate MRI Scan Agents May Cause Gadolinium Toxicity and MRI scan injury
Gadolinium-containing contrast agents may increase the risk of a rare but serious disease called nephrogenic systemic fibrosis (NSF) in people with severe kidney failure. Nephrogenic systemic fibrosis triggers serious health conditions like the thickening of the skin, organs and other tissues. Researchers at the Mayo Clinic have found direct evidence of gadolinium deposition in neuronal tissues in patients undergoing MRI scans with gadolinium-based contrast agents. Gadolinium exposure can affect the kidneys and lead to nephrogenic systemic fibrosis (NSF), and lawyers claim the MRI scan contrast agents have led to problems in other organ systems as well.
In May 2007, an FDA kidney specialist issued a report of an “undeniable and strong association” existing between contrast agents containing Gadolinium and NSF. Patients facing a significant risk of developing NSF include those suffering from kidney malfunction, advanced renal failure, liver transplantation patients, and people suffering from chronic liver diseases.
More recently, the FDA announced a new class warning requirement and other safety measures for all companies distributing gadolinium-based contrast agents (GBCAs) for MRI imaging. Gadolinium retention has not been linked to adverse health effects in patients with normal kidney function, though other risks may exist for patients. The FDA announced it is requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, including a patient Medication Guide that every patient will be asked to read before receiving a GBCA. The FDA is also requiring GBCA manufacturers to conduct further studies to assess the safety of these agents.
MRI scans are important diagnostic medical tests used to produce images of the body to detect problems such as cancer, infections or bleeding. GBCAs are the intravenous drugs that contain gadolinium, used to help improve visualization of internal organs, blood vessels and tissues. GBCAs are injected into a vein during an MRI, and are thought to be mostly eliminated from the body through the kidneys. Studies show, however, that trace amounts of gadolinium may stay in the body long-term, making it an imperative for health care professionals in Ohio to consider the retention characteristics of each agent.
Known adverse health conditions related to gadolinium retention are rare conditions called nephrogenic systemic fibrosis (NSF) and Gadolinium Deposition Disease (GDD) occurring in a small group of patients with pre-existing kidney issues. The FDA has received reports of adverse GDD events involving multiple organ systems in patients with normal kidney function. Ohio product liability attorneys claim Gadolinium is to blame.
The FDA is requiring a new class warning for all GBCAs about gadolinium remaining in the body for months or years after receiving the drug. Manufacturers of GBCAs are now tasked with conducting human studies to further assess the safety of their contrast agents. The FDA is also requiring a patient medication guide providing educational information.
The U.S. Food and Drug Administration (FDA) has suggested that health care professionals consider potential retention characteristics of imaging agents when choosing a GBCA for patients at higher risk for gadolinium retention. Such patients include those requiring multiple doses, pregnant women, children, and patients with inflammatory conditions. Ohio doctors are urged to minimize repeated GBCA MRI imaging tests when possible.
If you or a loved one suffered an MRI scan injury related to Gadolinium toxicity, and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions regarding MRI scan injury lawsuits.