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Amid recent concerns about gadolinium toxicity symptoms linked to linear MRI contrast agents, such as Omniscan, Magnevist, Multihance and others, the findings of a new study suggests that no link was seen with use of Dotarem, a gadolinium-based MRI dye that has a non-linear structure, known as a macrocyclic.
Gadolinium is a toxic metal contained in MRI and MRA contrast agents, which is designed to help enhance the exam results. The gadolinium dyes have two structural categories, including linear and macrocyclic, which involve ways the metal is contained or chelated.
Although consumers are told the dye is safely processed out of the body before the chelation breaks down, concerns have emerged in recent months about toxicity symptoms from the MRI contrast agents, as some individuals are left with deposits of gadolinium that may accumulate in their brain or other parts of the body. This may result in bone and joint pain, skin discoloration or thickening, persistent headaches, nerve damage or other problems.
Macrocyclic gadolinium is considered to have a more stable structure, which means that it is less likely to lose chelation and thus more likely to be passed through the body without being deposited in organs than linear ionic gadolinium contrast dyes.
In research published earlier this month in the medical journal European Radiology, researchers from the U.K. used electronic health records to evaluate the incidence of toxicity among individuals with renal impairment who received the macrocyclic gadolinium contrast agent Dotarem.
Researchers collected data on patients who underwent contrast-enhanced MRI scans using Dotarem and looked for hypersensitivity reactions, diagnoses of nephrogenic systemic fibrosis (NSF), reports of chronic pain and post-contrast acute kidney injury, and other symptoms commonly linked to gadolinium deposition disease.
According to the findings, from a review of nearly 23,000 gadolinium-enhanced MRI scans from 2004 through 2016, 14% of those were performed on patients with poor kidney functions, known as renal insufficiency (RI). However, the researchers found no cases of NSF and only two cases of hypersensitivity. They also failed to find higher rates of chronic pain in that group compared to those in controls.
NSF is a more severe and debilitating form of gadolinium toxicity that has been identified by health officials as a risk of individuals with kidney impairment. However, recent concerns have also extended to individuals without any kidney problems, who may be left with gadolinium in their body following use of linear contrast agents.
In December 2017, the FDA issued a drug safety communication for MRI contrast agents, providing new information about the risk of gadolinium retention and potential side effects for individuals with normal kidney function.
Manufacturers of linear gadolinium contrast agents now face a growing number of MRI toxicity lawsuits brought by individuals who claim the dye caused them to develop severe and debilitating health problems, after gadolinium was retained in their body.