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News, Drug & Medical Device
MRI Drugs Omniscan & Magnevist May Leave Toxic Residue in Brain
Experts at The University of Pittsburgh Medical Center and Ohio State University have called for more research into possible health risks of a potentially toxic chemical, gadolinium, remaining in brain tissue of patients who receive MRI scans.
Three new studies, discussed in an article published in the medical journal, “Radiology”, have shown that gadolinium-based contrast agents including Omniscan by GE Healthcare and Magnevist by Bayer HealthCare, may leave chemical deposits in the brain tissue of patients who received the medications. The concentrations of gadolinium remaining in neural tissue was higher when the patient had required multiple MRI procedures.
Though it is widely known that gadolinium and other rare earth heavy metals may be toxic to mammals, gadolinium-based contrast agents have been in use for many years both inside and outside of the U.S.
Gadolinium had previously been shown to remain in other tissues such as epithelial (skin) and connective tissue of patients with renal damage and in 2006, the drugs like Omniscan and Magnevist were linked to nephrogenic systemic fibrosis (NSF), a crippling condition that may be fatal.
In 2007, the Food and Drug Administration required that a “black box” warning be added to prescribing information for gadolinium contrast agents. The black box warning states that patients who have kidney impairment may be unable to excrete gadolinium and may be at higher risk of NSF.
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 in patients with impaired kidneys.
Previously it was thought that gadolinium risk affected only patients with significant renal damage and did not affect the brain. These studies are especially concerning to medical experts as they show the first evidence that the chemical may cross the blood-brain barrier and may also be deposited in the bones of patients who do not have decreased kidney function.
Some patients have reported significant decline in cognitive processes and support groups have formed for patients suffering from injury after receiving gadolinium contrast agents, but manufacturers have stated that the studies showed that “no clinical effect” such as “brain injury” has been confirmed and have denied liability.
Bayer and GE have both previously settled hundreds of lawsuits after other injuries by their radiocontrast agents, some of which have involved death. Both companies have continued to deny liability in all cases but one patient in Cleveland was awarded a $5 million verdict after suing GE for the development of NSF. GE appealed but one year later when the verdict was upheld, the patient had died.
Newer radiocontrast agents which apparently do not pose the same threat are available and the researchers at the University of Pittsburgh and the University of Ohio have recommended that prescribing practice should prioritize the use of those agents which do not pose the same risks. They have also called for additional studies on the effects of Omniscan, Magnevist and other older gadolinium-based agents and are encouraging continuing efforts to develop more effective MRI agents.
Bayer and GE have said that there is no evidence of clinical importance surrounding the gadolinium-brain issue but that they are “monitoring” the situation.
Seeger Weiss LLP is offering free consultations for patients who received gadolinium-based MRI contrast agents such as Omniscan or Magnevist, and suffered NSF, cognitive decline or other injuries. Injured patients may be entitled to compensation for pain and suffering, present and future medical care, and other losses stemming from their injuries. For more information, visit the firm’s website, or contact Seeger Weiss LLP directly at 877-541-3273.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.