Gadolinium-based contrast agents are chemical compounds that, when injected into patients prior to an imaging test (such as an MRI or CT scan), produce clearer images and improve the accuracy of diagnoses. The Food and Drug Administration (FDA) has approved five gadolinium contrast dyes, including Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. The FDA has not approved the use of gadolinium contrast dyes in magnetic resonance angiography (MRA, a special type of imaging test that can significantly improve the diagnosis of heart attack, cardiovascular disease, and stroke).
Despite the positive attributes of gadolinium contrast agents, they have been found to cause a debilitating, incurable condition known as nephrogenic systemic fibrosis (NSF, also referred to as nephrogenic fibrosing dermopathy or NFD). NSF is a relatively new disease, with the first reported cases documented in 1997.
Nearly a decade later, in 2006, the link between gadolinium dyes and nephrogenic systemic fibrosis was uncovered when researchers found NSF is strongly related to kidney function. Those with impaired kidney function are most commonly afflicted with this rare condition. Because the kidneys are primarily responsible for expelling gadolinium dyes from the body, when the kidneys are not functioning properly, these chemicals stay in the body and greatly increase a patient’s risk of developing nephrogenic systemic fibrosis.
NSF Definition and Symptoms
NSF is a rare condition in which the connective tissues in the skin, joints, eyes, and internal organs thicken and become fibrous, particularly in the extremities (though, in some patients, the torso may also be effected). As nephrogenic systemic fibrosis progresses, the skin hardens, forms plaques, and prevents an individual from being able to contract and extend his joints. This will dramatically impair an individual’s range of mobility and weaken his muscles. If left untreated, patients may no longer be able to walk.
There is no cure for nephrogenic systemic fibrosis, so treatments concentrate on bolstering kidney health while also minimizing the debilitating symptoms of the condition.
FDA Warnings and Gadolinium Contrast Lawsuits
In December 2006, the FDA issued a nationwide warning regarding the danger of developing NSF (particularly for those with impaired kidneys) after being exposed to gadolinium dyes. Additionally, the FDA mandated that the manufacturers of all five approved gadolinium agents include Black Box warnings on all packaging (Black Box warnings are the most serious level of FDA warning before a drug recall).
If you or a loved one has been diagnosed with nephrogenic systemic fibrosis and has a history of gadolinium dye exposure, you are welcome to learn more about your legal rights and receive a professional assessment of your case during a complimentary consultation.
If you or a loved one have used Omniscan, Magnevist, MultiHance, OptiMARK, or ProHance and suffered from NSF, you should contact us immediately for a free and confidential case review. You may be entitled to compensation and our defective drug attorneys can help.