Gadolinium MRI Side Effects
The product liability lawyers at Saiontz & Kirk, P.A. previously investigated cases for individuals who may be suffering from side effects of gadolinium used in MRI contrast agents, such as Omniscan, Optimark, Magnevist and others. The buildup of the MRI dye may result in the development of a painful and debilitating condition, known as Gadolinium Deposition Disease (GDD).
Within hours or weeks after an imaging exam, MRI contrast side effects may cause individuals with normal kidney functions to develop symptoms like:
- Persistent Headaches
- Bone and Joint Pain
- Reduced Cognitive Function
- Tendon and Ligament Pain
- Thickening Of Soft Tissues
- Nephrogenic Systemic Fibrosis
Gadolinium Deposition Disease is a progressive condition, which means that it gets worse over time. There is also no known cure, and the only cause of gadolinium in the body is an MRI contrast dye.
While new claims are no longer being accepted or reviewed, this page is provided for informational purposes to outline the claims previously investigated.
Gadolinium-Based Contrast Dye Risks
Gadolinium is a rare earth metal with unusual metallurgic properties, which make it useful in enhancing magnetic resonance imaging (MRI) and other scans. The first gadolinium-based contrast dye was introduced in 1988, and a number of products are now distributed by different manufacturers.
The MRI contrast dye is delivered by an intravenous injection before the exam, allowing doctors to enhance the image. While many individuals believe the injections are safe, gadolinium poses serious risks that should be considered when deciding whether a contrast agent is needed.
Concerns About Gadolinium Buildup in the Body
The first reports suggesting problems with the MRI contrast dye came as early as 1989, when some doctors identified a build-up of gadolinium in brain lesions. This raised concerns, because gadolinium is known to be a highly toxic heavy metal. However, false and misleading information was provided to the medical community that suggested gadolinium could not cross the brain-blood barrier, because it was covered in a protective barrier in a process known as chelation.
Research has shown that this protective barrier may not last, as the body leached the barrier away due to interactions with metals in the body, such as zinc, copper and iron. This suggested that if gadolinium dye was being retained in the body, eventually the barrier might break down, exposing the body’s tissues to the toxic chemical.
Gadolinium Toxicity Not Limited To Those With Kidney Problems
Initial concerns about the build-up of gadolinium in the body were focused on individuals with reduced kidney function, whose bodies may not be efficient in removing the dye. Amid reports of a life-threatening condition known as nephrogenic system fibrosis (NSF), which causes a progressive hardening and thickening of the skin, the use of gadolinium among individuals with kidney problems was eventually contraindicated.
However, as early as 2004, studies suggested that there was also gadolinium build-up in the bodies of patients with normal kidney functions as well.
In recent years, studies have found evidence of retained gadolinium in the brains of individuals with normal renal function, raising concerns about the possible long-term side effects of the MRI contrast agents.
FDA Warnings About Gadolinium Retention
In December 2017, the FDA issued a drug safety communication about the potential risk of gadolinium build-up in the body.
The regulatory agency required a new safety warning and other measures for individuals undergoing an MRI with contrast, to make sure they were aware of the potential gadolinium risks, and the possibility that gadolinium may remain in the body or brain for months to years after the MRI.
The FDA is now requiring that patients be given a Medication Guide, detailing the possible side effects of gadolinium contrast dye. Manufacturers were also called on to conduct additional human and animal studies, raising questions about why earlier steps were not taken to examine the risks of gadolinium deposits.
Doctors are now cautioned to consider factors that may pose a higher risk for gadolinium retention, including:
- Multiple MRI with Contrast Agents Over a Lifetime
- Pregnant Women
- Individuals with Inflammatory Conditions
- Minimize Repeated Gadolinium MRI Exams
- Avoid Closely Spaced MRI Gadolinium Injections
If earlier warnings and information had been provided about the potential long term side effects of gadolinium in MRI contrast dye, many individuals may have been able to avoid a debilitating and painful disease.
Gadolinium Deposition Disease (GDD)
Gadolinium Deposition Disease (GDD) is a relatively new term, used to describe a wide range of adverse effects believed to be linked to gadolinium toxicity from the build-up of the metal in the body. However, since many doctors are not yet familiar with the condition, the symptoms may not initially be diagnosed as gadolinium disease.
Researchers are continuing to learn more about the condition, but reports suggest several common complaints:
- Symptoms typically develop within days or weeks of an MRI or MRA;
- Initial side effects usually involve persistent headache, clouded thinking, bone and joint paint;
- Thickening of soft tissue, which may appear spongy or rubbery;
- Painful tendons and ligaments;
- Tingling, pins and needles, cutting or burning pain;
- Progressive worsening that may limit use of the arms, legs, hands, feet or other joints;
- Wheelchair, walker or need for other assistive device;
There is no known cure or treatment for gadolinium toxicity, highlighting the importance of avoiding the condition in the first place.
Timeline of Gadolinium Poisoning Risk
Inventors of gadolinium contrast agents claim that coating the chemical in a protective barrier, a process known as chelation, prevented it from crossing the blood-brain barrier, making it useful for MRI scans.
FDA approves first gadolinium-based MRI contrast dye, Magnevist. That same year, researchers indicated that gadolinium could break through the protective barrier as the body tried to leach away the chelation materials for other purposes.
Doctors at the University of California San Francisco reported a case of Erdheim-Chester disease in the journal Radiology that remained enhanced on MRI scans for eight days, suggesting that gadolinium may be retained in the lesions for extended periods of time.
Various doctors warn that gadolinium deposition is occurring in patients with kidney problems.
Doctors begin to warn of gadolinium deposition in patients with normal kidney functions.
FDA issues warning of cases of nephrogenic systemic fibrosis (NSF) linked to individuals with kidney problems who received gadolinium contrast dye injections.
FDA adds NSF black box warning to gadolinium contrast dyes, indicating that patients should be screened for kidney problems.
FDA adds new warnings to gadolinium contrast agents, instructing doctors on how to minimize risks of NSF.
Manufacturers settle gadolinium lawsuits over NSF diagnosed among individuals with reduced kidney function.
The FDA warns that Magnevist side effects may cause hypersensitivity and allergic reactions.
Japanese researchers warn about gadolinium retention in the brains of patients with normal kidney functions.
The Mayo Clinic publishes a study in Radiology, warning that there is a dose-specific relationship between gadolinium injections and the amounts of gadolinium detected in brain tissue.
Shortly after the Mayo Clinic Study, the FDA issues a warning on potential gadolinium retention and begins studying the safety risks for individuals with normal kidney function.
University of North Carolina researchers publish a study in Magnetic Resonance Imaging which warns that gadolinium toxicity, or gadolinium deposition disease, appears to follow administration of gadolinium contrast agents.
Another Mayo Clinic study indicates that gadolinium deposition can occur in human brain tissue without intracranial abnormalities.
In December , the FDA adds a new class warning to gadolinium dyes, indicating that the chemical can be retained in other parts of the body besides the brain and again warns of the risk of NSF.
A study published in Current Problems In Diagnostic Radiology warns that many radiologists often detect gadolinium deposits in the brain, but fail to inform patients or report the findings.
Gadolinium Injury Lawyers
If you or a family member suspect that you may be suffering from side effects of gadolinium from MRI contrast dye was injected, contact the lawyers at Saiontz & Kirk, P.A. to review what legal options may be available.
Free consultations and case evaluations are provided for individuals nationwide, to help determine whether a settlement may be available for your gadolinium injury.
All gadolinium cases are being pursued by our attorneys on a contingency fee basis, which means that there are never any out-of-pocket costs to hire our law firm and we only receive a fee if compensation is obtained by our client.
Protect your family and find out if you may have a Gadolinium Deposition Disease lawsuit.