Gadolinium is a rare-earth metal used in the medical field because it is effective in X-ray, magnetic resonance imaging (MRI), computed tomography (CT), angiography, and ultrasound imaging.
The chemical helps to produce detailed images of internal organs to detect disease or abnormalities in the body. Gadolinium contrast agents were originally approved for MRI scan use in 1988, and now the most commonly used MRI medium.
But the use of products using the substance have raised concerns as the use has resulted in severe and debilitating injuries. Gadolinium-based contrast agents (GBCAs) may remain in the body and cause permanent injuries and conditions like Gadolinium Deposition Disease (GDD) and nephrogenic systemic fibrosis (NSF).
The U.S. Food and Drug Administration (FDA) recently issued a “Drug Safety Communication” warning that noted Gadolinium-based contrast agents (GBCAs) may be retained in the body, and new class warnings are required for manufacturers of contrast agents. The FDA aims to minimize the risk of contrast dye retention.
Even if Gadolinium Deposition Disease (GDD) and nephrogenic systemic fibrosis (NSF) are very rare complications, they are serious enough to warrant an investigation into the safety of the medical product. The FDA acknowledged that NSF in particular is associated with the use of GBCAs in certain patients with kidney dysfunction.
Joe Lyon is a highly-rated medical device attorney actively involved in product liability litigation nationwide.
FDA Gadolinium Warnings
The FDA announced a 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.
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.