Gadolinium is a heavy metal that is often used in contrast agents administered intravenously to patients who are undergoing an MRI. The use of gadolinium-based contrast agents enhances visibility of soft tissues, abnormalities, and diseases including cancer in MRIs. The gadolinium in these contrast agents is meant to be filtered out of the body through the kidneys after the MRI.
Gadolinium based contrast agents were first introduced to the medical industry in the US in 1987. Since their introduction, over 30 million doses of gadolinium based contrast agents have been administered worldwide. There are currently 2 types of gadolinium based contrast agents: linear agents and macrocyclic agents. Research has shown that the levels of gadolinium remaining in the body are higher with the linear gadolinium based contrast agents.
Research shows that in some patients, gadolinium can remain in the body after undergoing MRIs. This accumulation contradicts the prior belief that gadolinium would filter out of the body naturally through the kidneys leaving only trace amounts. More recent studies, however, show that gadolinium can accumulate and deposit in the brain, skin and bone. The reason for the accumulation is still unknown at this point.
The accumulation of gadolinium in the body can lead to a number of medical conditions including gadolinium storage condition, gadolinium deposition disease, and nephrogenic systemic fibrosis. Research is still ongoing to more completely understand the adverse effects of gadolinium deposits in the brain and other parts of the body.
As mentioned above, potential side effects from the use of gadolinium based contrast agents can include gadolinium storage condition, in which a patient has normal renal function and has excess gadolinium in the body but is not exhibiting any symptoms, and nephrogenic systemic fibrosis, in which the gadolinium retention can trigger a renal insufficiency. Additionally, the use of gadolinium based contrast agents can lead to Gadolinium deposition disease, which occurs in patients with normal kidney function, is caused by an accumulation of gadolinium in the body. Symptoms can occur within the hours or months after undergoing an MRI and can include the following:
In 2006, the FDA required a label change to warn of the risk of nephrogenic systemic fibrosis. After this label change, gadolinium based contrast agents were still considered safe for patients except for those with preexisting kidney issues.
On July 27, 2015 the FDA issued a safety announcements regarding gadolinium retention following MRIs with gadolinium based contrast agents. This safety announcement states that the FDA is investigating the risk of brain deposits following repeated MRIs with gadolinium based contrast agents. The announcement also cautioned health care professionals to reassess the necessity of repeated MRIs with gadolinium based contrast agents in established treatment protocols.
On May 27, 2017 the FDA announced that gadolinium is retained in the brain, but there had not been any identification of adverse health effects related to such gadolinium deposits at the time. On December 19, 2017 the FDA issued another announcement warning of gadolinium retention following MRIs with gadolinium-based contrast agents. This announcement also demanded additional label changes and more studies into the health effects of gadolinium accumulation.
Health authorities in other countries, including Japan, Singapore, Europe and the UK, have restricted or issued safety updates regarding the use of certain gadolinium-based contrast agents.
At this time, there have been gadolinium deposition disease lawsuits filed against the manufacturers of gadolinium based contrast agents in both state and federal courts. If you or a loved one had an MRI and are experiencing symptoms consistent with gadolinium deposition disease, you might have legal options. Please give us a call at (619) 237-3490 to discuss your potential options. Our gadolinium attorneys are reviewing potential cases involving gadolinium and gadolinium deposition disease.
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