Recently, an article published in “Radiology”, has shown that Magnevist and certain other radio-contrast agents used in MRI procedures may leave toxic gadolinium residue in the brain after its use. Some patients who have received the medication have reported a decrease in ability to think clearly and may be suffering due to gadolinium deposits in the brain.
Magnevist manufacturer, Bayer, has denied responsibility for any injuries. The company has stated that the studies do not confirm evidence of clinical impact by showing evidence of brain injury to patients. Experts have recommended additional study as the current results were from examinations done at autopsy, showing gadolinium brain residue in previous MRI patients.
This is not the first time that Bayer has faced lawsuits because of medical injuries caused by Magnevist. Multiple lawsuits were filed against Bayer for the development of a potentially fatal kidney condition known as “nephrogenic systemic fibrosis” (NSF). Many of these lawsuits were settled out-of-court but Bayer never admitted any wrongdoing. Now Bayer may be facing multiple lawsuits caused by cognitive damage related to Magnevist use.
Patients who suffer medical injury due to the use of a medication may be eligible for compensation for damages such as medical treatments, lost wages, future medical costs and pain and suffering. Each potential case of medical injury must be considered independently and filing a lawsuit is no guarantee of compensation but if you or a loved one has been injured by Magnevist use, your case should be evaluated by legal experts.
Magnevist Toxic Brain Residue
Magnevist is known as a “gadolinium-based contrast agent” (GBCA). Recent studies published in Radiology magazine, a well-respected medical journal have shown that gadolinium, the toxic core of GBCA’s like Magnevist may be left as a residue in the brains of patients who have had multiple MRI procedures.
Gadolinium is known to be toxic and even though previous evidence showed that it may be deposited in bone, skin and other body tissues of patients with severe kidney damage, this is the first time that gadolinium has been found in brain tissue. In addition, the results of the studies are particularly troubling as the deposits were found in patients who did not have damaged kidneys.
Some patients who have received multiple doses of Magnevist, have reported that they have experienced significant declines in cognitive or though processing. This has impaired the ability to perform normal daily functions and has resulted in job loss. Some of these patients have formed support groups, including one on Facebook, to discuss and seek help for physical symptoms caused by Magnevist use.
Bayer, the manufacturer of Magnevist, has denied any fault, stating that no evidence of “clinical” impairment has been shown but it is notable that study results were obtained upon autopsy of previous Magnevist patients. Bayer was previously implicated in Magnevist medical injury and though they settled many lawsuits, they continued to deny responsibility.
About Gadolinium-based Contrast Agents (GBCAs)
Gadolinium has been shown to be toxic in animal studies and even though it has dramatically improved diagnostic imaging capability, it has also been shown to be toxic in some patients. Recent evidence shows the threat may be larger than previously thought.
Magnevist, the first GBCA, has a “linear” chemical structure but newer agents have a “cage-like” chemical structure, which may make them safer as the “cage” may prevent the gadolinium molecule from being deposited in patient tissues such as the brain.
Though Magnevist was the first GBCA, Bayer invented a newer produce, Gadovist. The newer “macrocyclic” or cage-like agent was introduced in Europe in the late 1990’s but even though the company already knew about potential renal toxicity, they did not bring the safer drug to the U.S. until 2010. Some experts have long recommended that only the “safer” agents be used, unfortunately many U.S. physicians were not given the Gadovist option.
Magnevist is manufactured by Bayer, a Germany-based pharmaceutical giant which has estimated annual revenue of $44 billion. Magnevist contains the gadolinium substance, gadopentetic dimeglumine. It was the first gadolinium type contrast agent to be approved in 1987. Even though newer, potentially safer agents have been available in Europe since the late 90’s, including another Bayer product, Gadovist, Bayer did not choose to market Gadovist in the U.S. until 2010, well after major problems with older agents had surfaced.
In 1997, a severe condition known as “nephrogenic systemic fibrosis” was identified but no cause was known. In 2001, gadolinium contrast agents were suspected in several cases of renal injury but the two conditions were not connected until 2006 when a Danish physician connected NSF cases to gadolinium use. The Danish Medicines Agency initially identified 25 cases of NSF linked to gadolinium-based contrast agents, later expanding this number to over 150.
Though GE, the manufacturer of another GBCA, attempted to discredit the Danish physician by claiming libel and reporting bias, filing suit against him in UK High Court, the Commission on Human Medicines in the UK issued an advisory about the medications, warning against their use in really-compromised patients.
The FDA followed with a 2007 warning to U.S. physicians regarding NSF and required that a “black box” warning be added to gadolinium-based agents including Magnevist. Experts had recommended that the products be prohibited for use in kidney patients but that advice was not taken until 2010 when the FDA recommended that Magnevist not be used at all in patients with known kidney damage.
Since the ban on use in kidney patients, few additional NSF cases have surfaced but new studies show that the drug is potentially harmful to non-kidney patients, with the possibility of toxic gadolinium passing into the brain and being left there.
Side Effects of Magnevist
All medications, including contrast agents cause side effects. Most of the side effects are mild and usually temporary but some may be more serious or life-threatening.
Mild to moderate side effects of Magnevist may include:
- Unpleasant aftertaste
- Hot flash, flushing or cold sensation
More serious side effects may include:
- Allergic reactions such as:
- Difficulty breathing
- Renal symptoms such as:
- Urinary urgency and incontinence
- Swelling of extremities
- Extreme thirst
- Nephrogenic Systemic Fibrosis symptoms such as:
- Raised plaques or papules
- Colored skin areas
- Neurological symptoms such as:
- Loss of thought patterns
- Speech disorder
Serious adverse events should be immediately reported to medical personnel and may be considered to be an emergency.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.