MRIs help detect irregularities in body organs, blood vessels, and other tissues, such as cancer and multiple sclerosis. During these tests, doctors use contrast agents to create clearer pictures of the inside of a patient’s body.
Contrast dyes are typically injected through an IV and help doctors see the internal structures of the patient’s body more clearly. One type of contrast dye used often during these procedures is Gadolinium-based Contrast Agents, or GBCAs. These contrast agents contain gadolinium, a rare earth metal that doctors and researchers believed was excreted from the body completely soon after the imaging procedures were completed.
New research published in peer-reviewed medical literature, however, has led to new concerns over these types of contrast agents, exposing potential gadolinium deposits in the brains of patients who underwent multiple MRIs with GBCAs. This led the U.S. Food and Drug Administration (FDA) to issue safety warnings and conduct research of its own into the potential side effects of these potent dyes.
Following an investigation by the FDA into gadolinium-based contrast agents, or GBCAs, patients harmed by these drugs have begun filing lawsuits against their various manufacturers. Patients exposed to GBCAs during MRIs and other imaging tests may develop deposits in the brain or other organs because their kidneys were not able to remove all of the drug from their bodies. Research suggests that even patients with healthy kidney function could be harmed by these contrast agents.
Schmidt National Law Group is investigating potential litigation involving gadolinium-based contrast agents and patients affected by the drugs. If you had an MRI or other imaging test and developed adverse effects after being exposed to GBCAs, you may be entitled to financial compensation. There may be significant payouts and cash settlements awarded to those affected by gadolinium-based contrast agents.
Call the experienced lawyers and attorneys at Schmidt National Law Group today at 800-631-5656 for a free consultation and to see if you qualify for a Gadolinium Lawsuit.
Potential Gadolinium Lawsuits allege a number of legal claims against the manufacturer of these contrast agents, including:
Doctors use contrast agents during diagnostic imaging tests, such as MRIs (magnetic resonance imaging) and MRAs (magnetic resonance angiography), to enhance the quality of the images produced by the tests. The dye is injected into patients through an IV and helps doctors see a clearer picture of the patients’ internal organ and tissue structures.
There are different types of contrast agents used during these procedures, one of which is gadolinium-based contrast agents. Gadolinium is a rare earth metal and is injected into the veins to create contrast so doctors can better view the internal structures of the body during MRIs, MRAs, and other imaging tests.
Gadolinium is processed by the kidneys and is typically excreted from the body through urination. Gadolinium was approved by the FDA and has been in use for several decades. It was once believed that gadolinium was fully excreted by the body in the days and weeks following an MRI or other imaging procedure; however, new research suggests that small amounts of gadolinium may remain in the body of some patients and create dangerous buildups in the brain, bones, skin, and other organs.
Patients with poor kidney function may be at an increased risk for gadolinium buildup, but research shows even patients with healthy kidney function can experience symptoms of gadolinium buildup. Patients usually experience these dangerous buildups if they have undergone multiple imaging tests using GBCAs.
The FDA began investigating these agents after peer-reviewed research was published in the medical literature showing GBCAs could buildup in the body and create harmful gadolinium deposits. The organ most affected by these deposits was the brain, but gadolinium has also been shown to build up in the bones and other organs and tissues, including the skin.
The FDA investigated the use of GBCAs in patients undergoing MRIs and other diagnostic image testing and found gadolinium could build up the brain, skin, bone, and other organs and tissues.
The federal agency looked at studies published by researchers and manufacturers of the contrast agent and found GBCA was prone to separation, meaning gadolinium was separating from the molecules it was bound to create the GBCA and becoming free gadolinium in the body. This made it more likely to deposit in the brain than when gadolinium did not separate, research showed.
Because trace amounts of gadolinium can remain in the body long-term, the FDA recommends doctors limit a patient’s exposure to GBCAs and perform MRIs only when the additional information obtained from using the contrast is necessary.
GBCA has been shown to build up in the body, including in the brain, bones, skin, and other organs and tissues. The Lighthouse Project, a patient advocacy group, has been an active voice in the fight to get proper warnings placed on GBCAs regarding the drug’s safety.
According to the advocacy group, people with normal kidney function have shown signs of a rare disease that can develop in people with severe kidney impairment who are exposed to GBCAs called nephrogenic systemic fibrosis (NSF). The group said these symptoms “should be expected based on published findings associated with NSF.”
Patients with decreased kidney function who are exposed to GBCAs may develop nephrogenic systemic fibrosis. NSF is a rare but debilitating disease of fibrosis of the skin and internal organs. It is characterized by the thickening and darkening of large areas of the skin, and sometimes internal organs and muscles are affected.
Though NSF has been associated with people with impaired kidney function, some evidence suggests people with normal kidney function can develop symptoms of NSF.
NSF can begin days to months after exposure to GBCAs but progresses quickly. NSF is typically chronic and in some cases can cause severe disability or death.
Signs and symptoms of NSF, according to Mayo Clinic, include:
In some people, NSF may affect muscles and internal organs. In these cases, symptoms may include:
There are numerous studies showing the potential effects of exposure to gadolinium-based contrast agents, including the buildup of such agents in the brain, bones, kidneys, skin, and other organs and tissues. These potentially harmful side effects can occur in patients with normal kidney function, despite earlier research which suggested it occurred only in patients with severe kidney impairment.
A 2016 review published in the journal Biometals looked at a number of studies involving gadolinium toxicity published in the last couple of decades in an attempt to better understand how gadolinium may buildup and cause problems in the body.
The study authors found a significant amount of data available in published reports that indicate a potential for adverse effects in people who are exposed to GBCAs multiple times — most notably, NSF in patients with severe kidney impairment. However, the authors also found a significant amount of research showing a buildup of gadolinium in patients with normal or healthy kidney function, writing, “[G]adolinium deposition is now well established to occur despite normal renal function.”
This could mean adverse health effects are possible in people with healthy kidneys when exposed to GBCAs. Based on this knowledge, the authors said further research into potential side effects in these otherwise healthy patients was necessary.
The study authors concluded:
“Unequivocal data regarding the effects of multiple GBCA exposure are limited. However … the emerging data regarding gadolinium tissue accumulation in those with normal kidney function indicate that the potential toxicity associated with GBCA must be seriously and urgently considered. This concept must be addressed with retrospective and prospective cohort studies. Research providing additional mechanistic data is also paramount and will provide valuable information regarding how to prevent GBCA-related toxicity, treat existing GBCA-related health issues, guide the use of existing GBCAs, and direct the design of safer MRI contrast agents.”
The FDA has issued several warnings about GBCAs in the past few years after questions about the drugs’ safety were raised. The FDA began investigating GBCAs in 2015 and, in 2017, the agency required the manufactures of GBCAs to make changes to their labels because of potential safety concerns.
July 2017 Safety Communication
In 2015, the FDA issued a safety communication regarding GBCAs after multiple publications in medical literature showed gadolinium deposits could build up in the brains of people who underwent multiple MRIs. The publications showed even patients without kidney impairment could be affected. Prior to these studies, only patients with severe kidney impairment were known to be adversely affected by GBCAs.
The federal agency said it would conduct an investigation into the possible side effects of these contrast dyes, alongside the medical community and industry leaders. At the time, the FDA did not require manufacturers to make changes to the drug labels.
The agency did, however, make recommendations for doctors whose patients may be exposed to GBCA when undergoing an MRI or other imaging tests. In its July 2017 safety communication, the agency wrote:
“To reduce the potential for gadolinium accumulation, health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary. Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols.”
The agency also recommended patients and their caregivers talk to their doctors and healthcare professionals should they have any questions about the safety of these drugs. It also urged patients to report adverse events to the FDA’s MedWatch program.
May 2017 Safety Communication
In May 2017, the FDA issued an updated safety communication after conducting reviews of the scientific literature regarding gadolinium buildup in the body. The FDA said the literature showed gadolinium can build up in the body and deposit in the brain and other organs and tissues. The agency could not say, however, that these studies showed any adverse events associated with the gadolinium deposits and said more research was needed.
The agency reiterated its 2015 recommendations for doctors and patients, including limiting the use of GBCAs to “circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs.”
December 2017 – New Class Warnings
Following the FDA’s investigation of GBCAs, the agency announced it would require new safety measures for all gadolinium-based contrast agents on the market. These safety measures included requiring a new patient Medication Guide and providing educational information for every patient to read before receiving a GBCA.
These new safety measures came as the FDA continues to investigate the risk of GBCAs. Although current literature does not show specific adverse events associated with GBCAs in patients with healthy kidney function, the FDA believes further studies are needed.
In its December 2017 announcement, the FDA wrote:
“To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure. FDA received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established.”
In light of these reports, the FDA said it was requiring the manufacturers of GBCAs to conduct additional studies in humans and animals to further assess the safety of these contrast agents.
There are several different types of GBCAs sold under various brand names. Some GBCAs have been shown to put patients at an increased risk of gadolinium deposits than others, but all GBCAs currently on the market fall under the FDA’s new labeling changes.
The following are GBCAs available on the U.S. market, according to the FDA, with the generic names in parentheses:
Biometals. “Gadolinium-based contrast agent toxicity: a review of known and proposed mechanisms.” Moshe Rogosnitzky and Stacy Branch. Published online April 6, 2016. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4879157/
U.S. Food and Drug Administration. ”FDA Drug Safety Communication: FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI).” Published July 27, 2015. Retrieved from: https://www.fda.gov/Drugs/DrugSafety/ucm455386.htm
U.S. Food and Drug Administration. “Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication – No Harmful Effects Identified With Brain Retention.” Published May 22, 2017. Retrieved from: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm559709.htm
U.S. Food and Drug Administration. “Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication – Retained in Body; New Class Warnings.” Published Dec. 19, 2017. Retrieved from: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589580.htm
Mayo Clinic. “Nephrogenic systemic fibrosis.” Updated June 16, 2016. Retrieved from: https://www.mayoclinic.org/diseases-conditions/nephrogenic-systemic-fibrosis/symptoms-causes/syc-20352299
The Lighthouse Project. “Coauthors of The Lighthouse Project provide facts about Gadolinium Toxicity to the FDA Advisory Committee.” Posted August 30, 2017. Retrieved from https://gadoliniumtoxicity.com/2017/08/30/lighthouse-project-provides-facts-to-fda-advisory-committee/