The US Food and Drug Administration (FDA) announced it will require additional warnings for gadolinium-based contrast agents (GBCAs) alerting patients to a potential risk of gadolinium retention.
The move comes after a hearing about gadolinium at which various experts and patients spoke about gadolinium retention in the human body, including in organs and the brain. Patients discussed the side effects of having gadolinium retained in their body.
Gadolinium toxicity lawsuits have been filed, with more lawsuits likely as patients become aware they may suffer from this condition.
New Gadolinium Drug Warning By Manufacturer
In May 2018, an Important Drug Warning was sent out by the makers of GBCAs alerting health care providers to the updated prescribing information for the agents. The updated information is included in the Warnings and Precautions, Adverse Reactions, Pregnancy, Clinical Pharmacology and Patient Counseling sections and concerns the potential for gadolinium retention, especially in the bone and organs. The highest retention is seen with linear GBCAs rather than macrocyclic GBCAs. Patients at the highest risk of gadolinium retention include those taking multiple lifetime doses, pregnant patients, children, and patients with inflammatory conditions.
“Consequences of gadolinium retention in the brain have not been established,” the warning notes. “Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function.” Furthermore, according to the warning, patients with normal renal function have shown pathologic skin changes.
Of the GBCAs, those that cause the highest retention according to the updated warning are Omniscan and Optimark, followed by Eovist, Magnevist, and MultiHance. The lowest retention is seen in Dotarem, Gadavist, and ProHance. Health care providers are required to advise patients that gadolinium can be retained in the brain, bones, or organs of patients with normal renal function for months or years.
Gadolinium is used in contrast agents injected in many patients who are undergoing an MRI to enhance the image created by the MRI. There is evidence that gadolinium does not leave the body as quickly as the drug manufacturers promised. Instead, it is being retained in various parts of the body, putting the patient at risk of exposure to excess gadolinium.
Gadolinium Side Effects
Gadolinium retention has been linked to several medical conditions, including the following:
- Gadolinium storage condition
- Gadolinium deposition disease
- Nephrogenic systemic fibrosis
Gadolinium Storage Condition
Gadolinium storage condition refers to situations in which a person has the normal renal function but has been diagnosed with excess gadolinium in their body.
Gadolinium Deposition Disease
Gadolinium deposition disease refers to situations in which a person has normal or adequate renal function but develops persistent and/or painful symptoms anywhere from a few hours to several weeks after being injected with a gadolinium contrast agent. Those symptoms of having gadolinium poisoning include pain in the arms and legs, bone pain, tissue burning and brain fog.
Nephrogenic Systemic Fibrosis
Nephrogenic systemic fibrosis (NSF) refers to situations where renal insufficiency is linked to gadolinium retention. In such cases, the gadolinium cannot be removed from the body adequately because the patient suffers from kidney problems. The patient then experiences thickening and darkening of the skin, shortening of the muscles and tendons, and other symptoms, which can be fatal.
FDA Gadolinium Warning
In September 2017, the U.S. Food and Drug Administration (FDA) voted 13-1 (with one abstention) to add a warning about the risk of gadolinium retention after use of gadolinium-based contrast agents. Several Cutter Law clients were present during the vote and shared their experiences with the FDA. See Chuck Norris’ article discussing the FDA hearing and the frustrations that he and his wife have experienced.
Gadolinium Toxicity Class Action
Most people believe that when a lot of individuals are injured by a single product or medicine that the victims would find a law firm to file a class action lawsuit. Since the injuries are never exactly the same for each person, we instead file an individual lawsuit that is part of a Mass Tort, not a class action. A Mass Tort is similar to a class action in many ways but it involves hundreds or thousands of plaintiffs. Each plaintiff’s case is handled and resolved on its own merits and successful plaintiffs are awarded varying monetary amounts depending on the severity of their injuries.
Gadolinium Toxicity Lawsuits
In October 2016, Cutter Law filed the first gadolinium deposition disease lawsuit against the maker of a gadolinium-based contrast agent, alleging patients were not properly warned about the risks associated with gadolinium retention. Since that time, we have filed several lawsuits for victims living across the country in both state and federal courts.
If you or a loved one has suffered from gadolinium toxicity, contact our attorneys immediately to discuss your options. Our attorneys are available to answer your questions and are committed to fighting to protect your rights.