MRI Contrast Agents
Magnetic Resonance Imaging (MRI) scans use magnetic fields and radio waves to generate pictures or images of organs and tissues inside of the body. MRI contrast agents are IV medications, also called “radiopaque” agents which increase visibility and allow for more information to be gathered during these scans.
Gadolinium-type contrast agents are some of the most popular types of IV dyes which are used during MRI procedures as the gadolinium concentrates in certain types of tissues, to make them more visible during a scan. Unfortunately, gadolinium-based contrast agents (GBCAs) have also been shown to have severe side effects in some people.
Three studies recently published in “Radiology” have shown that certain gadolinium-containing medications, including Magnevist and Omniscan, used in MRI scans may leave potentially toxic residue in the brains of patients who have had the agents administered to them.
Some patients who have received gadolinium-type contrast agents have reported decline in cognitive and thought processes, but the manufacturers have claimed that the same studies confirming brain residue did not demonstrate “brain injury”. The manufacturers of the gadolinium-based contrast agents have denied liability, but some patients may be filing lawsuits regarding medical injuries.
MRI Drugs Lawsuits
Many patients and families of those who were diagnosed with or died from NSF after receiving Magnevist, Omniscan, or OptiMARK have filed lawsuits against the manufacturers. Some of these lawsuits have been settled, while others are still pending.
Recently, attention has begun to focus on other damage that may be caused by GCBA drugs like Magnevist and Omniscan and some patients have reported significant cognitive decline with resulting job loss and personal difficulties. Many of these patients have formed support groups, including one on Facebook regarding the damage that may be caused by GCBAs
Even though the recent studies indicate that gadolinium toxic residue may be left behind in brains of patients who have had MRI procedures, manufacturers have stated that the studies showed that “no clinical effect” such as “brain injury” has been confirmed and have denied liability, though it is notable that the reports only addressed autopsy results.
Investigators have indicated that additional research is needed to further examine the effects, and many patients who have suffered cognitive or other neurological effects may be filing lawsuits against Bayer, GE and other manufacturers.
About Gadolinium-based Contrast Agents (GBCAs)
Gadolinium has been widely used around the world as a radio-contrast agent in MRI procedures. It has dramatically improved the quality of diagnostic information that can be gained from an imaging procedure. It is also sometimes called “radiopaque” as it appears opaque on radiology imaging scans like magnetic resonance imaging (MRI
Unfortunately, even though it is helpful to many patients, gadolinium has caused a number of serious health concerns including nephrogenic systemic fibrosis (NSF), kidney damage, liver damage, cardiac damage, and is most recently suspect due to its deposition in brain tissue.
There are three basic types of gadolinium-based contrast agents (GCBAs) including:
- Linear standard relaxivity agents (Magnevist, Omniscan, OptiMARK)
- Macrocyclic agents (Dotarem, Gadavist, ProHance)
- High-relaxivity agents (Ablavare, Eovist, MultiHance)
Damage caused by GCBAs appears to be related to how much of the central molecule “gadolinium” is allowed to “escape” from the medication. Older “linear” agents such as Magnevist and Omniscan, are more likely to emit gadolinium than newer “macrocyclic” agents which hold the molecule in a chemical “cage”.
In addition, evidence has shown that though the agents do leave deposits of gadolinium in tissues such as bone, skin, and connective tissue, it was previously thought that the gadolinium would not be of significant concern in “normal” patients with functioning kidneys and that the medications would likely not cross the blood-brain barrier. The medications were expected to clear body tissues within a reasonable amount of time and to never have entered brain tissue.
The recent journal report is concerning to medical professionals as it indicates that previous beliefs may be untrue and need reconsideration.
Magnevist and Omniscan
Two of the most popular radiopaque agents, Magnevist and Omniscan, have also caused the most concern regarding neurologic side effects and kidney damage.
Magnevist is a radiocontrast agent manufactured by Bayer Healthcare, a Germany-based pharmaceutical and medical product giant, with estimated annual revenue of $44 billion. It contains the gadolinium substance, gadopentetate dimeglumine.
Omniscan is manufactured by GE Healthcare, a division of General Electric which has estimated annual revenue of $148 billion. Omniscan contains the gadolinium substance, gadodiamide.
Magnevist was first approved in 1987 and was the first MRI contrast agent to be used, Omniscan was approved in 1993, followed by OptiMARK in 1999. Since then, newer agents have been introduced but these agents have continued to see widespread use, particularly in the U.S.
Magnevist, Omniscan and OptiMARK are of the older gadolinium type of MRI contrast agents with a different type of chemical structure than newer agents. The older agents are “linear” in chemical structure and may be more likely to release the gadolinium molecule itself, making them more toxic than newer agents which hold the gadolinium molecule in a macrocyclic complex, similar to a chemical cage.
GBCAs and Blood-Brain Barrier
Reportedly, the gadolinium agents in Magnevist and Omniscan were unable to cross the “blood-brain” barrier, meaning they could not enter actual brain tissue in a healthy patient and were limited to circulation in the bloodstream, however some MRI patients have “leaky” vessels which are a primary reason for MRI procedures, but which may also allow the drug to enter the brain.
The studies discussed in the recent Radiology journal article indicate that not only does gadolinium enter brain tissue but that it may remain there after the MRI procedure has been completed and the drug is expected to have cleared the body. The studies examined neurologic and brain tissue of deceased patients who had previously had Magnevist or Omniscan. Patients who had multiple MRIs showed higher rates of drug residue.
Availability of Safer Agents
Critics of older medications such as Magnevist and Omniscan have noted that newer agents, such as the macrocyclic Gadavist, are available and may be safer than the “linear” agents. However even though these drugs were approved in Europe and other places around the world as early as 1998, Bayer did not even apply for U.S. FDA approval for Gadavist until 2010 – after reports of another potentially fatal side effect had come to light.
A rare, potentially fatal condition, known as nephrogenic systemic fibrosis (NSF) was identified in 1997, five years after the contrast agents were introduced but physicians were initially mystified as to the cause. In 2001, Omniscan had been implicated in three cases of renal toxicity and pancreatitis and Magnevist has also been implicated in at least on episode of cardiac failure after its use but gadolinium-containing contrast agents did not become a known suspect as a factor in the development of NSF until early in 2006.
After study of the condition, a Danish radiologist reported case studies of MRI patients who had developed the disorder. The reports initially included 30 patients, which was later expanded to over 150 patients. The Danish Medicines agency sounded the alarm, identifying 25 specific cases linked to Omniscan. In June of 2007, the Commission on Human Medicines in the UK issued an advisory warning against the use of Omniscan in renal patients.
The same Danish radiologist was subsequently sued for libel by General Electric in the UK High Court with GE claiming that there was a “reporting bias” and that “no causal link” had been proven.
In December of 2006, the FDA began to investigate reports of gadolinium-related NSF occurrences and in 2007, the agency required that a “black box” warning be placed on labeling regarding the risk of NSF in gadolinium-based contrast agents. Internal documents show that GE’s own experts urged the company to limit the use of Omniscan in certain patients, but the advice was ignored.
Two FDA reviewers had advised banning Omniscan, Magnevist and a similar drug, Optimark for use patients with severe kidney disease but the agency did not act on that advice until 2010 when it recommended that the drugs not be used at all in patients with impaired kidneys.
These new studies are especially concerning to medical experts as they show the first evidence that the chemical crosses the blood-brain barrier and may also be deposited in other areas of patient’s bodies in those who do not have decreased kidney function.
Side Effects of Magnevist and Omniscan
All medications, including contrast agents like Magnevist and Omniscan may have side effects. Most of these are mild to moderate but some may be more severe or life-threatening.
Less serious side effects may include:
- Hot flash or flushing
- Unpleasant taste in mouth
- Burning or pain at injection site
- Cold feeling or clamminess
More serious effects may include:
- Allergic reaction
- Facial or tongue swelling
- Difficulty breathing
- Neurological symptoms
- Mood changes
- Speech disorder
- Renal symptoms
- Urinary incontinence
- Increased thirst
- Urinary urgency
- Nephrogenic Systemic Fibrosis
- Raised skin plaques
- Skin papules
- Colored skin areas
Any serious adverse event symptoms should be reported to a medical professional immediately and treated as an emergency.
Omniscan and Magnevist Settlements
In 2009, a group of GCBA lawsuits filed for nephrogenic systemic fibrosis. was organized in multidistrict litigation (MDL) in federal court in Ohio. That MDL closed and was settled by 2015. Despite publicly denying problems, both Bayer and GE have privately settled hundreds of lawsuits associated with the contrast agents. Many were wrongful death suits filed by patients’ loved ones.
One Cleveland case went to trial in 2013 and resulted in a $5 million verdict against GE. The verdict was upheld by a federal appeals court last year, but by the end of the appeals process the plaintiff had died.
Another potential lawsuit involved Marcie Jacobs, a woman who began undergoing MRIs in 2001 to closely monitor her breast cancer risk. As the MRIs continued over the years, Jacobs noticed her cognitive function declining. She eventually ended up on disability and after a series of test, found that her symptoms were caused by an accumulation of gadolinium in her breast, livers, thighs, and brain.
Jacobs is a perfect example of why the most recent studies are relevant – she had no history of kidney disease but had received Omniscan for her first 11 MRIs and Magnevist for at least one of her final tests. She is hoping the FDA will pull both agents from the market and that others will not be forced to endure the illness and arduous task of removing gadolinium from their bodies, as she was forced to do.
Newer Omniscan and Magnevist Lawsuits
The most famous case perhaps is a 2017 lawsuit filed by actor Chuck Norris and his wife Gena over three MRIs that utilized GBCA medications. The Norris’ claim that Gena developed neurological damage and other complications including kidney damage, pain and loss of energy, requiring nearly $2 million worth of medical treatments over a five-year period. Their case has yet to be resolved.
In 2018 for plaintiffs in 21 cases of Magnevist or Omniscan injury requested that the lawsuits be consolidated into multidistrict litigation (MDL). Lawyers indicated at that time, that they expected hundreds of cases to be filed, however the request was denied. Multiple cases are still pending, and information continues to emerge.
If you or a loved one has suffered medical injury after receiving gadolinium-containing MRI drugs such as Magnevist or Omniscan, you may be eligible for compensation for medical costs, lost wages and pain and suffering.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- I.V. drug used during an MRI leaves toxic metal residue, Pharmacists.com (06/2015)
- Gadolinium Found in Brain Tissue, Medscape (03/2015)
- FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images, U.S. Food and Drug Administration (05/2007)
- FDA Drug Safety Communication: New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction. U.S. Food and Drug Administration (12/2010)
- FDA Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (10/2013)
- FDA panel gives nod to Bayer’s Gadovist MRI contrast agent, Aunt Minnie (01/2011)
- GE Failed to Adequately Warn about Dangers of its MRI Dye, Jury Finds, ProPublica (04/2013)
- Bayer settles some Magnevist lawsuits, Reuters (04/2009)
- GE Can’t Escape $5M Omniscan Verdict, 6th Circ. Says, Law360 (10/2014)