Gadolinium-Based Agents
Gadolinium Side Effects Lawyers
Gadolinium is the active ingredient in a product called Omniscan™, made by GE Healthcare. Omniscan was approved by the FDA in 1988 and became the preferred contrast agent when administering an MRI (Magnetic Resonance Imaging) or MRA (Magnetic Resonance Angiogram) to patients with chronic kidney disease.
A contrast agent is a substance injected before a MRI or MRA and causes a visual difference on the resulting films, between normal tissue and abnormal tissue. Previously, the contrast agents used had been iodine-based. The use of iodine-containing contrast agents continues to be a common cause of acute renal failure.
At first it seemed that Gadolinium-based agents were safe and well tolerated. However, after more studies were done the connection emerged between Omniscan and a disease known as Nephrogenic Systemic Fibrosis (NSF).
What is NSF?
NSF is a systemic condition where excessive connective tissue forms in the skin and internal organs. It is progressive, so that the skin becomes thickened and increasingly hard and coarse, and in some cases prevents the full use of legs, feet, arms and hands. Since NSF can also affect internal organs, it can be fatal.
When a patient has moderate to severe kidney disease, use of Omniscan should be minimal and avoided if possible. Gadolinium is eliminated from the body through the kidneys, and if kidney function is normal, elimination happens without incident. If kidney function is badly impaired, filtering and elimination is adversely affected and the gadolinium becomes toxic. Kidney dialysis should then be considered to get it out of the body. Research is ongoing to learn more about why and how NSF develops.
Advisories and Safety Updates
In June 2006, GE Healthcare, who manufactures Omniscan, issued a safety advisory after being informed of more than 50 new cases of NSF connected with Omniscan. These cases were observed in patients who had received high doses of Omniscan. GE warned healthcare professionals to carefully balance the risks and benefits of using Omniscan, and to inform any patients with kidney disease about the possible side effects.
In December 2006, the FDA issued a safety update in which they reported having received news of a total of 90 NSF cases in the U.S., and about 215 cases worldwide. This safety update warned that all five approved gadolinium-based contrast agents could be causing NSF. The other four are: OptiMARK, Magnevist, ProHance, and MultiHance.
Nephrogenic Systemic Fibrosis (NSF)
If you have been given any injection that contains gadolinium, you will not know about it unless you inquire. Your first step would be to contact your physician. He/she can decide whether further inquiry is necessary, can examine your symptoms and general health, and take further medical action.
Your second step would be to contact a Gadolinium Side Effects lawyer. Our Gadolinium side effects lawyers have extensive experience representing victims of defective drugs throughout the United States. We represent our clients on a contingent fee basis, which means we get paid only after we bring about a recovery of damages for our clients.