Recently, the safety of the MRI contrast agent, Omniscan has come under additional scrutiny. Three studies just published in the medical journal, “Radiology”, have shown that gadolinium-containing radiopaque medications like Omniscan may leave toxic gadolinium residue in the brains of MRI patients. Some patients have reported significant decline in cognition or thought processes.
GE, the manufacturer of Omniscan has denied liability for these potential injury cases, stating that no evidence of “brain injury” has been proven but this is not the first time that the company has faced potential liability due to injuries caused by Omniscan.
Many patients filed lawsuits against GE for NSF injury claims against Omniscan. One case resulted in a jury award of $5 million for damages caused by Omniscan. GE has also settled other NSF lawsuits out-of-court but terms of the settlements have not been disclosed.
In addition to the many lawsuits filed by patients injured by Omniscan’s potential to cause the serious kidney disease known as nephrogenic systemic fibrosis (NSF), GE may be facing additional lawsuits regarding toxic brain residue.
Patients who file lawsuit against drug manufacturers for medical injury may be eligible for compensation for medical costs, lost wages, pain and suffering and in some cases, patients are eligible for punitive damages if the company knew about the risks but continued to sell the drug anyway.
Each case is unique and a lawsuit is no guarantee of a settlement. If you or a loved one may have suffered injury after receiving Omniscan during an MRI procedure, you should have your case evaluated by legal experts.
Omniscan Toxic Brain Residue
Gadolinium-type contrast agents like Omniscan have previously been shown to leave medication residue in bone, skin and connective tissue but a recent journal article indicates that the medication may be leaving the toxic chemical behind in patient’s brains.
Radiology, a well-known medical journal has published results of three studies that show that certain gadolinium-containing MRI medications including Omniscan may leave the toxic chemical, gadolinium behind in patients’ brains.
Some patients have reported significant decline in ability to perform normal cognitive processes such as basic accounting needed for a job. These patients are no longer able to work and several have formed support groups, including one on Facebook so that they can connect with other sufferers of the side effects.
GE and another gadolinium-contrast agent manufacturer (Bayer) have both denied that the journal-reported studies show a link between neurological decline and their medications but the studies were done at autopsy and not as cognitive tests on potential victims.
The studies are of particular concern because it was the first time that gadolinium deposits had been seen in tissues, particularly brain tissue of patients with “normal” kidneys and researchers agree that more research is needed to prove a connection.
About Gadolinium-based Contrast Agents (GBCAs)
Though the substance is known to be toxic, Gadolinium has been in use around the world as a part of many radio-contrast agents. Its use has dramatically improved the capability of diagnostic imaging, but it has caused a number of serious health concerns including an increased risk of kidney damage, liver damage, cardiac damage and the acquired kidney condition, nephrogenic systemic fibrosis (NSF). The most recent evidence of potential for serious harm appears to be the deposition of gadolinium in brain tissue of patients who have had MRI procedures.
Omniscan is an “older” gadolinium-type contrast agent with a “linear” chemical structure. Newer agents are called “macrocyclic” and holds the gadolinium molecule in a “cage” which appears to make it safer, with a lower chance of gadolinium residue being left in patient tissues.
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. It was the second gadolinium type contrast agent to be approved and even though newer, potentially safer agents have been available in Europe since the late 90’s, these newer agents were not brought to the U.S. until much later.
The manufacturer of Omniscan, GE, originally purchased the Omniscan product from a British company in 2003. By 2006, Danish medical experts had already begun to sound the alarm about Omniscan and similar contrast agents with the identification of a link to a rare, but potentially fatal condition, known as nephrogenic systemic fibrosis (NSF).
The condition had been first noted in 1997, five years after the contrast agents were introduced but the cause was initially unknown. In 2001, Omniscan had been implicated in a three cases of renal toxicity but the agent did not become known as a factor in the development of NSF until early in 2006.
After the Danish Medicines Agency identified an initial 25 NSF cases linked to Omniscan, which was later expanded to over 150, the Commission on Human Medicines in the UK issued an advisory against using Omniscan in renal patients.
GE Healthcare sued the original Danish researcher in UK High Court for “libel”, claiming that there had been a “reporting bias” and claiming that no direct link had been proven between Omniscan and NSF.
Following the Danish report, the FDA also issued an advisory warning and required a “black box” warning be added to gadolinium-contrast agents including Omniscan. Internal GE documents show that the company’s own experts had urged the company to limit Omniscan use in certain patients, but the company’s leaders had ignored the advice.
When the FDA issued the original warning, experts had recommended that agents like Omniscan be prohibited from use in kidney patients but the agency did not act on the advice until 2010 when an additional warning recommended that Omniscan not be used at all in patients with impaired kidney function.
The new studies are particularly alarming to medical professionals as they show that the drug is potentially harmful and may leave toxic residue in the brains and other tissues of patients with “normal” kidneys.
Side Effects Omniscan
All medications cause side effects. Most of these effects are mild or temporary but some may be more serious or life-threatening.
Common side effects of Omniscan may include:
- Unpleasant taste in mouth
- Cold, clammy sensation
- Hot flash or flushing
More serious effects may include
- Allergic reactions including rash, swelling, difficulty breathing, anaphylaxis
- Renal symptoms such as incontinence, urgency, swelling of the extremities or extreme thirst
- Nephrogenic Systemic Fibrosis symptoms of raised plaques or papules and colored skin areas
- Neurological symptoms including mood changes, confusion, speech disorder, seizure and coma
Any serious adverse should be reported to a medical professional immediately and treated as an emergency.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.