The Food and Drug Administration is requiring the manufacturers of gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI) scans to issue a warning about the potential safety hazards of these products. According to the FDA, when GBCAs are used during an MRI, gadolinium can remain in a patient’s body – including the brain – for months or even years after the scan.
The FDA says that so far, it has not identified any adverse health risks associated with gadolinium retention in patients with normal kidney function. However, in light of concerns about gadolinium retention and previous warnings about the long-term dangers of gadolinium brain deposits, the FDA is requiring doctors to provide patients with a new Medication Guide about the health risks of gadolinium before they are treated with GBCAs.
Gadolinium is a heavy metal that can help to identify cancers, infections, bleeding, or other abnormalities during an MRL. The GBCAs that have been approved by the FDA for use in an MRI include Ablavar (gadofosveset trisodium), Dotarem (gadoterate meglumine), Eovist (gadoxetate disodium), Gadavist (gadobutrol), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine), Omniscan (gadodiamide), OptiMARK (gadoversetamide), and ProHance (gadoteridol).
Gadolinium is highly toxic, but usually the contrast agent is eliminated from the body by the kidneys, posing no long term health risks. However, patients with abnormal kidney function may have problems eliminating gadolinium from their body, putting them at risk of a rare and serious condition known as nephrogenic systemic fibrosis (NSF). In 2007, the FDA ordered manufacturers of gadolinium to issue a black box warning about the risk of NSF.
Patients who developed NSF or other complications from gadolinium after undergoing an MRI with GBCAs have filed lawsuits against the manufacturers of these products. In 2013, a jury awarded $5 million in damages to a 61 year-old man who was diagnosed with NSF after receiving just one dose of the GBCA Omniscan.
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Patients who have suffered complications from dangerous drugs or medical products may be eligible to take legal action. The first step in filing a product liability claim is to speak with an attorney who can advise you regarding your legal rights and guide you through the first steps of filing a claim.
The lawyers at Heygood, Orr & Pearson have resolved hundreds of claims involving defective medical products, dangerous drugs, and medical malpractice on the part of doctors, hospitals, and medical products manufacturers. Our firm believes that when drug and medical device manufacturers fail to ensure that their products meet basic health and safety standards, they should be held accountable for the injuries caused by their products in a court of law.
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