TRUTH: Gadolinium in its naturally-occurring form is toxic to the human body.
TRUTH: The FDA has called for further research involving the safety and toxic buildup of gadolinium-based contrast agents.
TRUTH: The FDA has required improved warning labels and information to be shared with patients when considering the use of gadolinium-based contrast agents.
The case against gadolinium is escalating. If you’re experiencing signs of gadolinium toxicity, seek medical help and legal representation. Don’t go it alone.
Contact our highly-qualified legal team today for help determine the next steps for your gadolinium case.
Each year 11% of people in the USA receive an MRI (magnetic resonance imaging) or MRA (magnetic resonance angiography). Out of those, 30-50% are asked to use a contrast agent to help provide a better picture of their health. One in three contrast agents include gadolinium as an ingredient. As you can see, usage of gadolinium is widespread.
Lawsuits involving gadolinium have occurred for nearly a decade, but recent news or radio segments are starting to pop up about its dangers. The public has a right to understand what they’re taking and what the risks are in contrast agents, various imaging tests, and ingredients such as gadolinium.
What Is Gadolinium?
Gadolinium is a heavy and rare earth metal that responds to magnetic energy. Its ability to absorb neutrons and the paramagnetic property has enabled the element to be used in a variety of applications.
Primarily, it is used by radiologists as a chemical contrast agent. There are two types of contrast agents based on their chemical composition, linear and macrocyclic. Gadolinium is found in linear contrast agents.
Gadolinium contrast agents are often used to help target tumors in neutron therapy by providing a more accurate picture of a patient’s health. There are non-medical uses as well. In metal or salt form, gadolinium is occasionally used in nuclear facilities for shielding or emergency shutdown measures.
Why Do Radiologists Use Gadolinium-Based Agents?
In its liquid form used as a contrast agent, gadolinium-based contrast agent (or GBCA) is injected into patients before receiving an MRI or MRA. This agent, when administered into the human body, magnifies the presence of abnormalities or disease due to the reaction gadolinium has with the magnetic field during the scan. For this reason, radiologists may consider gadolinium to provide a more enhanced view in the resulting images.
What Is Gadolinium Made Of? Is It Toxic?
Gadolinium itself is a rare, but naturally-occurring element that is toxic to humans in its natural state. The gadolinium-based contrast agent (GBCA) used by radiologists is made of the gadolinium ion and a chelating agent, or carrier model, which is used to counteract the toxicity of gadolinium yet still maintain its contrasting properties for MRI and MRA scans.
Who Makes GBCA?
Gadolinium-based contrast agents are manufactured by a number of companies, with each brand using a different chelating molecule. Companies that produce gadolinium-based contrast agents and their brand names can be found in the list below.
● Magnevist (Bayer-Schering) - Linear Ionic
● MultiHance (Bracco Diagnostics) - Linear Ionic
● ProHance (Bracco Diagnostics) - Macrocyclic Non-Ionic
● Omniscan (GE Healthcare) - Linear Non-ionic
● Dotarem (Guerbet) - Macrocyclic Ionic
● Gadavist (Bayer) - Macrocyclic Non-ionic
● Evoist or Primovist (Bayer) - Linear Ionic
Dangers of Gadolinium
Although it may be confusing, gadolinium is not specifically radioactive. Gadolinium in its natural state is toxic to humans, so there are other illness risks requiring further research to determine the long-term effects of gadolinium accumulation in the human body.
Gadolinium & The Human Body
Unlike lead or other metals that can enter the human body in small amounts during day-to-day activities, gadolinium only enters the body through the use of a contrast agent for MRI’s and MRA’s.
However, as with any foreign metal that enters the human body, a buildup can occur. When heavy metals such as gadolinium get backed up within the body, it can become toxic or even deadly. This is caused by foreign metal preventing normal functions in the organs, leading to health complications and potentially serious medical conditions, such as nephrogenic systemic fibrosis (NSF).
When this buildup occurs, many refer to it as gadolinium toxicity.
Does Impaired Kidney Function Cause Risk for Gadolinium Toxicity?
About 10 years ago, it was revealed that patients with impaired kidney function who received gadolinium experienced further health complications. One of the more common conditions was identified as nephrogenic systemic fibrosis (NSF). NSF is a disease that affects the internal organs and the skin, causing deposits and thickening or hardening in a variety of locations, which can become both uncomfortable and dangerous for patients.
The initial assumption was that these patients’ medical conditions made their bodies unable to effectively remove gadolinium. This resulted in the build-up of gadolinium to where it became toxic, causing the development of NSF.
We now know this isn’t true. In 2017, the FDA declared, “There is no direct correlation with healthy kidneys and developing NSF because of gadolinium,” but that further research on the risks of gadolinium build-up and its effects continue to be studied.
As of 2018, multiple cases have surfaced where patients with healthy kidneys developed NSF or are experiencing health-related complications believed to be associated with gadolinium toxicity. This is what has caused the spike in lawsuits, news coverage, and questions regarding its safety.
What Are Potential Side Effects or Disease from Gadolinium?
If you or a loved one underwent an MRI or MRA scan and received a gadolinium-based contrast agent, the following are potential side effects:
● Brain fog
● Skin irritations, such as discoloration, thickening, or itching
● Bone and joint pains
● Violent shaking
● Burning sensations
● Cognitive deficits
● Kidney damage
Some diseases that can develop from gadolinium toxicity include:
● Nephrogenic Systemic Fibrosis (NSF)
● Nephrogenic Fibrosing Dermopathy (NFD)
● Gadolinium Deposition or Toxicity Disease
Who Has the Highest Risk for Complications Involving Gadolinium?
In 2017, the FDA confirmed that the following patients would be most at risk of experiencing complications directly related to gadolinium toxicity and should not receive contrast agents that include the element:
● Expecting mothers or women who may be pregnant
● Children or the elderly
● Patients with dysfunction or severe kidney problems
● Patients who have already received multiple MRI scans that included injection of gadolinium-based contrast agent
Warning Signs of Gadolinium Toxicity
● Pain – aching; burning, tingling, and/or prickling pain (paresthesia); deep bone pain. Typically in extremities or joints, and sometimes in the location where the MRI occurred, like the head.
● Dermal changes – like tight skin, lesions, hyperpigmentation; most often in extremities.
● Muscle issues – twitching; small, local, rapid contractions and weakness.
● Ocular problems – worsening vision, dry eyes, bloodshot eyes.
● Cognitive symptoms
● Ear, nose and throat issues – tinnitus, swallowing, and voice problems
● Low body temperature
● Hair loss
● Itchy skin
● Balance problems
● Edema – swelling of extremities
What Are “Brain Deposits?” Are They Dangerous?
Gadolinium “brain deposits” are the accumulation of gadolinium in the human brain, specifically in the globus pallidus and dentate nuclei. Currently, only the injection of gadolinium-based contrast agents into the human body during MRI and MRA procedures introduces gadolinium that is absorbed into the human body. It generally requires multiple injections or scans for the build-up to take place.
In a 2017 study completed by the International Society for Magnetic Resonance in Medicine and tracked in the National Institutes of Health
, researchers found that the “extent of gadolinium deposition in the brain varies based on the agent” and that “the clinical significance of retained gadolinium in the human brain remains unknown, with data currently available for humans or animals showing the adverse effects gadolinium deposition has on the brain.”
It’s clear that more research is needed for gadolinium toxicity and potential patient risks to be fully understood.
Why Hasn’t the FDA Recalled/Banned Gadolinium?
The current stance of the FDA on gadolinium-based contrast agents is that the benefit of the approved agent outweighs the cost. In a public statement in 2017, the FDA declared “Gadolinium retention has not been directly linked
to adverse health conditions in patients with normal kidney function,” but that “manufacturers of GBCA products are required to conduct further human and animal studies
to better assess the safety of these contrast agents.”
A brief history of the FDA’s investigations into gadolinium-based contrast agents and their manufacturers follows:
● Lawsuits leading to pressure from the FDA required accurate GBCA labeling and warning to be given to patients about the risks associated with the agent.
In 2015, the FDA started looking into the risk of brain deposits
due to repeated usage of gadolinium-based contrast agents in patients.
In early 2017, the FDA publicly declared that “initial investigative research revealed no harmful effects of gadolinium build-up in the brain,” but that further review was needed
In late 2017, the FDA called for further warnings and safety measures to be put in place regarding GBCA’s, along with new class warnings
I’m a Victim of Gadolinium Toxicity. What Happens Next?
Investigations into gadolinium-based contrast agents have revealed a high probability that manufacturers and researchers have been aware of the risks associated with gadolinium in contrast agents, most likely since its introduction and approval by the FDA in the 1980’s.
You may be able to receive compensation if you fit some of the following criteria:
● Undergone multiple MRI’s with GBCAs
● Received multiple gadolinium-based contrast agent injections
● Been diagnosed with or showing symptoms of Gadolinium Deposition Disease, otherwise known as gadolinium toxicity
● Been diagnosed with or showing symptoms of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD)
Victims may be able to join a class action lawsuit or have one filed on their behalf to receive compensation. Speak with one of our attorneys experienced in medical lawsuits to help determine if you have a case and what your next steps should be.