Contrast agents are used during magnetic resonance imaging (MRI) procedures to increase image quality of tissues and organs. Products like Omniscan and Magnevist, based on the gadolinium molecule are some of the most popular MRI contrast agents available and are used in about one-third of all imaging procedures.
Though they may increase quality of image scans, they may also cause severe side effects and result in permanent injuries to kidneys, connective tissue, and other organs like the brain and central nervous system. Manufacturers of imaging products like Bayer and GE are facing hundreds of lawsuits filed by people who were injured after being given gadolinium-based contrast agents.
Gadolinium-Based Contrast Agents (GBCAs) include:
|Manufacturer||Brand Name||Generic Name|
|Bayer Healthcare||Ablavar, Vasovist||gadofosveset|
Gadolinium FDA Warnings
Gadolinium-based contrast agents (GBCAs) were first introduced in the late 1990s. They all contain gadolinium, a chemical element which has magnetic-type properties. When given as a contrast agent, the presence of gadolinium which is concentrated in organs and tissues makes areas of an image scan appear to be “darker” or more visible.
The use of GBCAs have been common practice and they are used in about one in three MRI procedures today, despite FDA warnings that have been issued over the years. In 2006, the U.S. Food and Drug Administration (FDA) issued a “black box warning” which required inclusion of certain safety alerts on all prescribing information for gadolinium contrast agents. The boxed statement on GBCAs includes warnings about a higher risk for nephrogenic systemic fibrosis (NSF). NSF is a disorder that can affect muscle and skin tissue and internal organs, particularly in those who have kidney disease.
Other Gadolinium Side Effects
GBCAs may also cause cardiovascular side effects and may result in allergic reaction. Patients who have had prior allergic reaction to contrast dyes should be closely monitored for several hours when GBCAs are used. Those with a history of respiratory disease or asthma may increase the chance for severe allergic reaction such as anaphylaxis.
A 2014 study also showed that gadolinium may be deposited in the brain where it may cause side effects relating to the brain and central nervous system. Patients have claimed to experience memory loss, speech difficulties, and other cognitive changes after using gadolinium contrast dye. Brain fog and other CNS symptoms have resulted in a number of gadolinium lawsuits, some of which may have been quietly settled.
In 2017, the FDA added new warnings about an increased risk of side effects in patients with compromised kidney function and stated that dosage adjustments may be needed in these patients.
Gadolinium Lawsuit Settlements
Since 2014, multiple gadolinium lawsuits have been filed by patients who experienced cognitive changes and other brain effects that may have been caused by deposits left within the brain tissue. Notable lawsuits include one filed by Chuck Norris and his wife, Gena after she reportedly suffered from skeletal effects and cognitive issues such as brain fog.
A number of groups have formed on social media platforms as well, with users comparing experiences. This may have resulted in an increase in the numbers of gadolinium lawsuits and though some of these cases may have reached private settlements, no disclosures have been made.
Though no large gadolinium group lawsuit filings have been announced, safety information continues to be disclosed and may indicate that more lawsuits can be expected. People who have suffered brain effects, memory loss, cognitive decline or other severe side effects after using Magnevist, Omniscan or other gadolinium contrast agents should seek advice from an attorney.
- The Debate Over Gadolinium MRI Contrast Toxicity, Imaging Technology News (2/2018)
- Information on Gadolinium-Based Contrast Agents, U.S. Food and Drug Administration (12/2018)
- FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings (12/2017)
- FDA issues tougher warning on MRI dye tied to brain effects, Medical Express (12/2017)