These are the questions that Casey Gerry San Diego pharmaceutical lawyers hear most frequently about NSF and Gadolinium Based Contrast Agents.
What is Nephrogenic systemic fibrosis, NSF?
Nephrogenic Systemic Fibrosis, sometimes called Nephrogenic Fibrosing Dermopathy, is a serious disorder of the skin and internal organs seen in patients with renal failure. It is caused by the use of Gadolinium Based Contrast Agents in MRI's and MRA's.
Symptoms include swelling and tightening of the skin, most frequently on the hands and/or the feet, but may involve the back, chest, and abdomen. Skin changes may start as reddened or darkened patches, and over time, the skin comes to feel stiff and woody. The skin thickening frequently occurs at joints, reducing the ability to bend, so that severely affected patients may be unable to walk, or fully extend their arms and hands. Many NSF patients experience progressive muscle weakness. In approximately 5% of patients, the crippling effects of the disease progress so rapidly that within weeks of onset they are confined to a wheel chair.
Patients may experience burning, itching, or severe sharp pains in areas of thickened skin. Some patients describe deep "bone pain" in their hips and ribs.
What is Gadolinium?
Gadolinium is a silvery white rare earth metal of atomic weight 64. It has a metallic luster, and it is strongly magnetic.
What is a GBCA?
Gadolinium Based Contrast Agents are fluids containing the element gadolinium. A GBCA is swallowed or injected before a magnetic resonance procedure, a contrast MRI or an MRA. The GBCA is selectively absorbed by certain tissues, causing the tissues to show very brightly in magnetic resonance imaging. The use of gadolinium contrast agents enables radiologists to view organs and structures more clearly, and make more precise diagnoses.
What are MRI's and MRA's?
Magnetic Resonance Imaging uses a magnetic field and pulses of radio waves to render images of the inside of a body, without cutting or otherwise invading the body. Magnetic imaging is used chiefly as a diagnostic tool, to find and evaluate abnormalities such as tumors and other alterations of living tissues.
Magnetic Resonance Angiography is the use of magnetic resonance to study the interior of arteries, in order to find aneurysms, blockages, tears in arterial walls, and narrowing of arteries.
How safe are Gadolinium and Gadolinium Based Contrast Agents?
For people with kidney disease and a history of renal insufficiency or renal failure, the use of Gadolinium Based Contrast Agents in magnetic imaging procedures presents a substantial risk of their developing Nephrogenic Systemic Fibrosis. The FDA has issued a strong warning against the use of these contrast agents for this population. For people with no history of kidney disease, the use of Gadolinium Based Contrast Agents in magnetic imaging appears not to present a risk.
Have Gadolinium Based Contrast Agents been recalled?
Despite the significant risk to people with kidney disease, Gadolinium Based Contrast Agents have not been recalled. They continue to be sold and used, with the FDA's black box warning in the package insert.
If I or a loved one has been injured by GBCA, what should I do?
If you or a loved one have had an MRI or MRA and then developed symptoms of NSF, you may have a claim against the manufacturer of the GBCA. You should have your case evaluated as soon as possible by an experienced pharmaceutical lawyer.
How can I know whether I've been exposed to Gadolinium?
If you have had an MRI or MRA, and a contrast dye was injected before or during the procedure, it's very likely you have been exposed to Gadolinium. You can contact the radiologist who conducted the MRI or MRA to find out what contrast agent was used. If a Gadolinium containing contrast agent was used and you have since developed symptoms like those described, you
should have your case evaluated as soon as possible by an experienced pharmaceutical attorney.