Omniscan Gadolinium Side Effects. The lawyers and attorneys at our firm are currently offering free consultations to patients who where injured by Omniscan, a gadolinium contrast dye manufactured by General Electric Company.
Omniscan and other gadolinium contrast dyes have been associated with the development of Nephrogenic Systemic Fibrosis (NSF) in patients with pre-existing kidney conditions. Our Omniscan injury lawyers have already filed several lawsuits against General Electric on behalf of patients who were diagnosed with NSF, a debilitating and often fatal disease, following a Magnetic Resonance Imaging (MRI) procedure that involved Omniscan. The investigation conducted by our NSF injury lawyers has determined that the chemical makeup of Omniscan makes it more likely that toxic gadolinium will be released into the bodies of recipients, placing kidney patients at a high risk of developing NSF.
Omniscan is a gadolinium contrast dye used in MRI procedures, and it is sometimes used during Magnetic Resonance Angiography (MRA) as well. Omniscan was introduced in 1988 by GE Healthcare, a subsidiary of General Electric Company. Gadolinium contrast dyes are injected into the bloodstream right before an individual undergoes an MRI or an MRA. The gadolinium helps the computer to differentiate between normal and abnormal tissue.
In most patients, gadolinium passes through the body in a relatively short time. But the bodies of people with kidney conditions are often unable to eliminate the gadolinium, a factor that puts them at risk for NSF. At the time it was introduced, no warnings were given that Omniscan put kidney patients in danger. The Omniscan injury lawyers at our firm have determined that General Electric failed to adequately test Omniscan for potential side effects. We have also determined that the company failed to warn of the deadly potential posed by Omniscan, and our Omniscan injury lawyers intend to hold General Electric and its subsidiaries accountable for this negligence.
Gadolinium contrast dyes such as Omniscan could potentially injure millions of people. According to the National Kidney Foundation, some 20 million people have chronic kidney disease. The foundation also estimates that 20 million more are at increased risk for developing chronic kidney problems. The Omniscan injury lawyers at our firm understand how devastating a diagnosis of NSF can be for a victim and their loved ones. We are committed to helping those suffering from Omniscan injuries obtain the compensation they deserve.
Nephrogenic Systemic Fibrosis
NSF is a rare, and often deadly disease that causes severe fibrotic changes to the skin, tissue and organs of those affected. Symptoms of NSF may appear within two days or even as long as 18 months after exposure to a gadolinium contrast dye. The dosage of the gadolinium contrast dye associated with the onset of NSF can vary as well. Some patients have developed the disease after receiving only one dose of Omniscan, while other patients who received a higher dosage also developed NSF.
There is no cure for NSF, and it is often fatal. NSF is a relatively recent phenomena, as the first case was only diagnosed around 1997, and NSF was not even seen in medical literature until 2000. NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. NSF leaves it victims unable to work, and they often face massive medical bills, as well as tremendous pain and suffering. The Omniscan injury lawyers at our firm have helped many victims of Omniscan in their fight against General Electric.
Because NSF is such a rare, recent disease, not much research has been done into this condition. However, what work has been done has consistently pointed to a link between NSF and gadolinium contrast dyes such as Omniscan. In 2006, Dutch researchers were the first to link NSF with the use of gadolinium contrast dyes. Following the 2006 discovery, the FDA warned healthcare professionals that gadolinium based agents had been tied to multiple cases of NSF. Although these cases were not limited to one gadolinium based contrast agent, Omniscan was among the gadolinium contrast dyes that were most often associated with the onset of NSF.
Since 2006, several other studies have found a direct association between NSF and gadolinium contrast dyes. Researchers at Yale University have reported that 95 percent of those with NSF had undergone an MRI procedure that involved a gadolinium contrast dye two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with gadolinium contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.
Omniscan MRA Side Effects
Our Omniscan injury lawyers have determined that the gadolinium contrast dye puts kidney patients at an even higher risk of developing NSF when Omniscan is used during an MRA. This is a type of MRI that is used to provide pictures of blood vessels inside the body. Often gadolinium based MRI contrast agents are used to enhance these images. The use of gadolinium based MRI contrast agents for MRAs is an off-label use that has never been approved by the FDA.
For Omniscan to be effective in an MRA, it must be administered at three times the approved dose. If a person’s kidneys are not functioning properly, it is extremely unlikely that so much gadolinium will be eliminated from the body. This makes it far more likely that a patient with kidney disease will develop NSF if exposed to Omniscan. In fact, some of the first reports of NSF actually occurred in patients who were exposed to gadolinium based contrast dyes during MRAs.
FDA Omniscan Warnings
The FDA has issued many warnings in the past several years regarding gadolinium contrast dyes, such as Omniscan, and their link to NSF. Following the publication of the Dutch NSF study in 2006, the FDA issued an alert to healthcare providers that gadolinium contrast dyes had been tied to multiple cases of NSF. At that time the FDA warned physicians to screen patients for kidney problems prior to using Omniscan or other gadolinium contrast dyes during MRIs.
In May 2007, the FDA requested that a black box warning the FDA’s strongest possible safety warning be placed on the label of Omniscan and other gadolinium contrast dyes highlighting the risk these products posed to patients with kidney problems. The FDA warned that patients who are at risk for NSF should be monitored by their doctors, and told to report any symptoms associated with the condition immediately.
The FDA advised that people with kidney disease should avoid gadolinium contrast agents. However, this is not always possible. If an MRI with a gadolinium contrast dye is required, the FDA has warned that the dose of the gadolinium contrast agent should not exceed that recommended in the products label and that a repeat administration of the gadolinium contrast agent should not be performed until enough time has passed to allow for the gadolinium contrast agent from the first MRI to be eliminated from the body. The FDA also recommended that patients who receive a gadolinium contrast dye who are already undergoing dialysis receive a dialysis treatment shortly following administration. Dialysis may help eliminate the gadolinium from the body, however it is not known if this will actually prevent NSF.
Finally, the FDA has warned against the use of Omniscan and other gadolinium contrast dyes in MRA procedures, as these agents have never been approved for this use. It is the opinion of our Omniscan injury lawyers that these warnings came far too late. Had General Electric adequately tested Omniscan, and placed appropriate warnings on its labeling, hundreds of kidney patients could have been spared the misery of NSF.