First approved by the Food and Drug Administration (FDA) in 1988 for use with magnetic resonance imaging (MRI), gadolinium-based contrast agents (GBCAs) are dyes that are injected into patients to elucidate abnormal cells and tissues in MRI results and similar tests. GBCAs are designed to help physicians make more accurate diagnoses.
The five GBCAs available in the U.S. include Omniscan (by GE Healthcare), Magnevist (by Bayer), Optimark (by Covidien), MultiHance (by Bracco Diagnostics, Inc.), and ProHance (by Bracco Diagnostics, Inc.).
Gadolinium Increases Risk of NSF
Regardless of its cutting-edge ability to aid in the diagnostic process, gadolinium dyes have been reported to cause a debilitating condition known as nephrogenic systemic fibrosis (NSF), also referred to as nephrogenic fibrosing dermopathy (NFD). NSF is a painful constriction of the connective tissues in the skin, muscles, joints, and some organs, which can seriously impair mobility. Should NSF affect the lungs, patients may have difficulty breathing, which can cause life-threatening complications.
To date, more than NSF 1,000 cases have been reportedly diagnosed in patients with a history of exposure to gadolinium contrast agents. Tragically, it has been reported that as little as one exposure can a patient to develop severe “potentially fatal “ gadolinium dye side effects.
In 2010, the FDA released a drug safety communication announcing that it was requiring GBCA manufacturers to add new warnings to their products. These warnings now alert healthcare providers and patients to the fact that these dyes can increase the risk of NSF, particularly in patients already at risk for kidney disease.
Gadolinium Deposits May Remain in the Brain
Once these dyes are injected into a patient, they help illuminate tissues and organs. The dyes are then supposed to be flushed out of the body via the kidneys within a few days. Some studies have indicated, however, that the dyes can remain in the body for months or even years.
In 2015, the FDA announced it was checking into these studies and evaluating the risks to determine whether these deposits could be harmful. Later studies continued to show potential problems.
In 2017, researchers reported in the scientific journal Radiology that gadolinium could cross the blood-brain barrier and accumulate in the brain. The researchers studied post-mortem tissue samples from five patients who went through MRI exams, yet had no visible problems in the blood-brain barrier. Results showed gadolinium deposits of various sizes in all five patients’ brains.
Lead researcher Robert J. McDonald told Radiology Business that the results challenged the current thinking that the blood-brain barrier would protect the brain from these deposits, “as gadolinium appears to accumulate even among patients with normal brain tissue….”
In a 2017 article published in the Lancet Neurology, researchers again noted that gadolinium deposits had been confirmed in brain tissue. However, the researchers also acknowledged that they didn’t know if the deposits were harmful or could cause any adverse health effects.
Considering these and other studies, the FDA announced in December 2017 that the agency was requiring new class warnings and other safety measures for all GBCAs used in MRIs “concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs.”
The FDA added that gadolinium retention “has not been directly linked to adverse health effects in patients with normal kidney function,” and stated that the benefits of the dyes continue to outweigh potential risks. The FDA also noted that it was requiring manufacturers to “conduct human and animal studies to further assess the safety of these contrast agents.”
A few months later, in May 2018, the FDA provided an update, stating that in addition to requiring the new warnings on the products, the agency had also approved new patient medication guides for all GBCAs. Such guides are given out to patients the first time they receive a GBCA injection, and now contain the updated warnings about the dyes.
Gadolinium Deposition Disease
Many patients who have received on or more injections of a GBCA have complained of a condition called “gadolinium deposition disease (GDD).” This condition creates symptoms similar to NSF, but those suffering from it did not have preexisting kidney disease. Still, partients can develop brain fog, tissue burning, bone pain, and other similar symptoms within hours to months after receiving the injection.
Researchers looked into this condition and reported on a survey taken in 2016. Researchers recruited participants from online gadolinium toxicity support groups, and asked them to respond to a series of questions. A total of 42 subjects responded. Results showed that the most commonly reported symptoms were:
- Central pain
- Peripheral pain
- Bone pain
Other symptoms included skin and tissue burning and brain fog. All of the patients reported “residual disease,” meaning they were still experiencing symptoms long after the MRI was over. About half said they started suffering these side effects after just one injection, and seven reported experiencing the side effects after multiple injections.
“Gadolinium toxicity appears to arise following GBCA administration,” the researchers wrote, “which appears to contain clinical features seen in Nephrogenic Systemic Fibrosis, but also features not observed in that condition.”
More research needs to be done to find out why some patients experience these effects. Meanwhile, some individuals who have suffered from GDD have filed gadolinium lawsuits in an effort to recover damages.
Omniscan litigation, whether in the form of individual or class action lawsuits, allows those who have been injured as a result of being exposed to gadolinium dyes to hold the maker of these dangerous agents legally and financially responsible for their negligence in failing to warn the public about the risks of using GBCAs. Injured parties can receive a thorough evaluation of their case, along with expert legal advice regarding how to proceed, and the opportunity to get their case started for no upfront cost by attending a complimentary initial consultation with a skilled attorney.
Injuries that may be associated with GBCAs include:
- Nephrogenic systemic fibrosis (NSF)
- Gadolinium deposition disease (GDD)
- Cognitive problems/brain fog
- Skin and tissue burning, or burning sensations inside the body
- Thickening or hardening of the skin, skin discoloration
- Joint pain
- Nausea and vomiting
While most Omniscan lawsuits are settled before the case ever goes to trial, gadolinium lawyers are passionate about defending the rights of those injured by GBCAs in any necessary legal proceeding, including mediation, arbitration, and trial. Gadolinium attorneys have extensive experience going up against corporate lawyers, and they will work tirelessly to help injured parties secure the settlement they deserve so victims can focus on recovering and moving on with their lives.
If you or a loved one have used Omniscan and suffered from NSF, you should contact our dangerous drug lawyers immediately for a free and confidential case review. You may be entitled to compensation, and we can help.