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New research suggests that most radiologists do not report problems with gadolinium from MRI contrast dyes that have built up in patients’ brain, raising concerns that issues may be much more prevalent that previously believed.
In a study published last week in the medical journal Current Problems in Diagnostic Radiology, researchers from the U.S. and Australia examined how often radiologists report on the gadolinium build up in the brain. The findings suggest that the doctors frequently do not feel the need to do so, despite rising concerns over the potential side effects and risks of gadolinium toxicity.
The report comes amid growing concerns that use of MRI dyes to enhance imaging tests have left users with a condition known as gadolinium deposition disease (GDD), which involves various symptoms, including reduced cognitive function, headaches, bone and joint pain, tendon and ligament pain, thickening of soft tissues and other problems. The condition is considered incurable and progressive, meaning that it worsens over time, raising concerns about the safety of gadolinium contrast agents.
The study involved an electronic survey of radiologists’ practices on gadolinium deposition from November 2015 through December 2015 and received responses from 94 subjects from 30 different countries. According to the findings, 62% of the radiologists reported seeing gadolinium brain deposition on MRI scans.
“Among respondents, 58% (52 of 89) do not or would not include the finding in the radiology report; only 12 (13%) report the finding in the impression of their reports,” the researchers found. “The most common reason for not reporting gadolinium deposition was the risk of provoking unnecessary patient anxiety (29%, 20 of 70).”
Researchers noted that the recent concerns over gadolinium deposition led to changes in the practices of 28% of the respondents. However, they concluded that recognition and attitudes toward brain gadolinium deposition were inconsistent and that fear of causing anxiety among patients and doctors, and an incomplete understanding of the potential risks, contributed to those inconsistencies.
The findings come about three months after the FDA issued new label requirements for gadolinium contrast agents such as OptiMark, Magnevist, Gadavist, Omniscan and other similar products, which provided new warnings that alert patients and medical professionals to the risk of gadolinium retention and side effects. The agency is also planning to require all gadolinium-based contrast agent manufacturers to conduct new human and animal studies to determine their safety.
The FDA is also recommending that health care professionals consider the fact that the body retains gadolinium when deciding whether to give it to patients that may be at higher risk of health problems. These include women who are pregnant or think they may be pregnant, patients with kidney problems, children, and patients when inflammatory conditions. The recommendations also suggest that repeated use of the contrast agents be minimized where possible, particularly when MRIs are scheduled closely together.
Patients are urged to tell their health care professionals whether they are pregnant or may be pregnant, whether they have kidney problems, and the date of their last MRI with gadolinium, or whether they have had repeated MRI scans that involved the use of gadolinium contrast agents.
MRI contrast agent manufacturers face a growing number of gadolinium disposition disease lawsuits filed in recent months, each raising similar indications that manufacturers failed to warn about the effects of exposure to the MRI contrast dyes used to enhance imaging tests.