Daniel R. - $10,500,000.00
Gadolinium-Based Contrast Agents (GBCAs)
Gadolinium-Based Contrast Agents (GBCAs) Highlights
- Used in MRI and MRA tests to evaluate blood vessels.
- Causes nephrogenic systemic fibrosis (NSF) and death.
- Patients with kidney problems at higher risk.
- FDA requested manufacturers to add box warning.
About Gadolinium-Based Contrast Agents (GBCAs)
Gadolinium-Based Contrast Agents (GBCAs) are approved by FDA for use with MRIs as a contrast agent to provide an improved image of body organs and tissues. There are five FDA approved GBCAs (Magnevist [gadopentetate dimeglumine], MultiHance [gadobenate dimeglumine], Omniscan [gadodiamide], OptiMARK [gadoversetamide], and ProHance [gadoteridol]). GBCAs are also used for magnetic resonance angiography (MRA), an imaging procedure used to evaluate blood vessels. MRA is a special type of MRI used to study blood vessels. MRA aids the detection of heart disorders, stroke, and vascular diseases. FDA has not approved GBCAs for use in MRA.
If you or a loved one has been diagnosed with Nephrogenic Systemic Fibrosis (NSF) after undergoing an MRI or MRA, you may qualify for a cash settlement. Please complete the form to the right and one of our attorneys will contact you or call 1-800-LAW-FIRM now!
Since December 2006, the FDA has investigated reports of nephrogenic systemic fibrosis (NSF) in patients who received GBCAs. Patients with acute or chronic severe renal (kidney) problems are at higher risk of developing NSF. NSF causes fibrosis of the skin and connective tissues throughout the body. Patients develop skin thickening that may prevent bending and extending joints, resulting in decreased mobility. NSF usually starts in the lower extremities. Fibrosis can also develop in the diaphragm, muscles in the thigh and lower abdomen, and lung vessels. Over time, NSF becomes worse and can cause death. There is no known treatment.
Conditions Caused By Gadolinium-Based Contrast Agents (GBCAs)
- Nephrogenic systemic fibrosis (NSF)
- Death
Side Effects & Symptoms
- Swelling, hardening and tightening of your skin
- Reddened or darkened patches on the skin
- Difficulty bending and extending joints
- Yellow raised spots on the whites of your eyes
- Burning or itching of your skin
- Decreased mobility
- Pain deep in you hip bones or ribs
- Muscle weakness
Warnings & Recalls
Since December 2006, the FDA has continued to investigate reports of nephrogenic systemic fibrosis (NSF) in patients who received gadolinium-based contrast agents (GBCAs) to help define risk factors for NSF. The FDA has requested the manufacturers of all five GBCAs (Magnevist, MultiHance, Omniscan, OptiMARK and ProHance) to add a new boxed warning and a new Warnings section to their labels to describe the risk of developing NSF.
Additionally, the FDA has requested that all manufacturers collect data on patients with varying degrees of renal insufficiency who are exposed to GBCA in order to more accurately estimate the magnitude of the risk for NSF in patients with kidney disease. The FDA will continue to evaluate new reports of NSF and may request additional studies and/or labeling changes.
Cases, Settlements, & Verdicts
There is currently a class action suit filed in the Ohio Northern District Court against manufacturers of GBCAs.
