Contact A Lawyer
Have A Potential Case Reviewed By An Attorney
Canadian researchers indicate that gadolinium deposits left in the brain by MRI contrast agents, such as Omniscan and Magnevist, may cause bright spots in later, non-enhanced MRI scans, adding to the growing evidence that toxic metal from the contrast dye may remain in the body long after it is administered.
In a study published in the August edition of the American Journal of Neuroradiology, researchers indicate that gadolinium deposition from previous injections can cause areas of hypersensitivity that show up on later scans, even when those scans do not involve the use of gadolinium-based contrast agents (GBCA). Researchers indicate that the findings suggest a dose-dependent relationship, which is a strong indicator of a causal link.
The research comes amid growing concern that gadolinium can build up in the brain and other organs, resulting in later health problems, now increasingly referred to as gadolinium deposition disease (GDD).
The study involved more than 200 subjects with secondary-progressive multiple sclerosis (MS) who were enrolled in a multicenter clinical trial. Researchers looked at data on 80 subjects who received nine linear gadolinium-based contrast agent injections over about a two year period, and 115 who received only three over the same time span.
According to the findings, the subjects in the high exposure group showed increased MRI signal intensity in all regions of the deep brain structures. Those in the low exposure group only showed increased signal intensity in the dentate nucleus.
“Hyperintensity in deep brain structures from gadolinium deposition is related to the number of doses and the type of linear gadolinium-based contrast agent (nonionic greater than ionic) administration,” the researchers concluded.
Concerns about the safety of MRI gadolinium contrast agents first emerged about a decade ago, when they were linked to the development of nephrogenic systemic fibrosis (NSF), a rare and life-threatening condition which was found to occur among patients with impaired kidney function, causing their skin to thicken and harden, severely restricting movement.
Sometimes referred to as gadolinium associated systemic fibrosis, NSF is a painful disorder that has no known cure and often results in confinement to a wheelchair and then death.
In 2007, the FDA limited gadolinium contrast doses in most kidney patients and contraindicated it for others, which limited the risk of NSF. In September 2010, the FDA went even further and banned the use of Bayer’s Magnevist on patients with kidney problems, due to the heightened risk of NSF.
The agency also required label changes for all gadolinium agents, warning healthcare professionals to screen patients before injecting gadolinium to identify those suffering from acute kidney injury or chronic, severe kidney disease.
However, manufacturers of the MRI contrast dye now face a new batch of gadolinium deposition lawsuits being pursued by individuals without any kidney problems, who developed severe and debilitating health problems they claim are linked to retention of metal in the brain and body, including bone and joint pain, cognitive problems, headaches, skin thickening and other complications.
In September 2017, the FDA’s Medical Imaging Drugs Advisory Committee voted to recommend the FDA require new MRI contrast agent warnings about the risk of gadolinium build up in the brain. However, in May the FDA concluded that gadolinium in the brain appeared to carry no threat of health effects.
In December 2017, the FDA issued a drug safety communication for gadolinium-based contrast agents, including Omniscan, OptiMark, Magnevist, Gadavist and others, providing new information about the risk of gadolinium retention and potential side effects.
The FDA recommended 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.