Gadolinium Contrast Agents
Gadolinium-based contrast agents (GBCAs) are injectable solutions which are used during a magnetic resonance imaging (MRI) procedure to improve visibility of tissues and organs during the scan. GBCAs are used in about one-third of all MRI procedures and have become a common practice.
MRI contrast agents based on gadolinium include:
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How Do Gadolinium Contrast Agents Work?
Gadolinium is a chemical element included on the periodic table as one of the “rare earth elements which is used for a number of industrial applications. In medicine, it demonstrates magnetic-like properties which makes it useful in magnetic resonance imaging (MRI). As it concentrates in tissues in various amounts, it increases the quality of scan images as tissues which have collected more gadolinium appear darker.
Imaging solutions which include the gadolinium ion are called “gadolinium-based contrast agents” or GBCAs. Gadolinium contrast agents have been used in over 300 million MRI scans since their introduction in 1998. Today, about one in three MRI procedures use gadolinium agents to improve image quality, though many scans can be performed without imaging contrast.
Gadolinium FDA Warnings
In 2006, the U.S. Food and Drug Administration (FDA) issued a black box warning for GBCAs. A black box or boxed statement warning requires that important safety information about a drug be printed at the top of drug information, enclosed by a thick black border and is the most serious safety warning that can be issued by the FDA.
The black box statement for GBCAs indicates that the drugs have been linked to an increase in the risk for nephrogenic systemic fibrosis (NSF). NSF is a rare type of disorder which occurs in people who have kidney disease or advanced kidney failure. It may resemble skin disease with thickening and darkening of the skin but also affects muscle, joint tissue and internal organs resulting in thickening or disabling contraction of certain tissues.
For patients who have compromised or decreased kidney function, the risk of NSF may be greatly increased when gadolinium-containing contrast agents are used. GBCAs may trigger the development of NSF and recognition of the link has been essential in limiting occurrence of the disorder. Additional warnings added in 2017 indicate that medication dosing should be adjusted for patients with compromised kidney function.
Gadolinium has also been linked to increased risk of allergic reactions, asthma and cardiovascular effects. People with a known allergy or history of intolerance to other contrast agents should be observed for several hours after administration of a GBCA if contrast must be used. In most cases, physicians will choose not to use the contrast agent if possible.
Gadolinium Brain Deposits
In 2014, study results showed that gadolinium may be deposited in brain tissue and cells and remain for long periods of time. This may lead to central nervous system side effects such as brain fog and other symptoms. Several notable lawsuits have been filed against Bayer, GE and other manufacturers of GBCAs, including Chuck Norris, whose wife reportedly developed seizures, memory loss and other CNS-related issues due to GBCA use.
Gadolinium manufacturers have collectively rejected claims that they are responsible for these conditions, however a number of lawsuits may have quietly been settled without public disclosure of the terms. Several manufacturers are still facing multiple lawsuits for injuries caused by GBCAs and people or loved ones of those who may have suffered CNS effects, kidney damage or other serious complications due to these medications should seek legal assistance.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- 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