Gadolinium is an FDA approved contrast agent for MRI and MRA. Gadolinium provides greater contrast between normal tissue and abnormal tissue in the brain and body. It looks clear like water and is non-radioactive. After it is injected into a vein, Gadolinium accumulates in the abnormal tissue that may be affecting the body or head. Gadolinium causes these abnormal areas to become very bright (enhanced) on the MRI. This makes it very easy to see. Gadolinium is then rapidly cleared from the body by the kidneys.
On May 23, 2007—The FDA announced that it is asking manufacturers of gadolinium-based contrast agents to include a black box warning alerting patients to the risk of a potentially fatal disease NSF (Nephrogenic Systemic Fibrosis) or NFD (Nephrogenic Fibrosing Dermopathy).
It is a condition which involves hardening of the skin, resulting in varying degrees of immobility, can damage internal organs, and is sometimes fatal. It appears to affect only those persons with impaired renal function caused by kidney disease. NSF / NFD is resistant to treatment and can be very painful and debilitating. Most importantly, NSF / NFD is entirely preventable.
The following gadolinium-based agents are implicated by the warning:
- Magnevist (gadopentetate dimeglumine)
- Omniscan (gadodiamide)
- OptiMARK (gadoversetamide)
- MultiHance (gadobenate dimeglumine)
- ProHance (gadoteridol)
The FDA has been aware of problems with gadolinium since at least June 2006, when the agency warned healthcare professionals about the risk of nephrogenic systemic fibrosis. A subsequent warning was issued in December 2006.
If you experience any of the symptoms of NSF / NFD after MRI (Magnetic Resonance Imaging) or MRA (Magnetic Resonance Angiogram), you should seek immediate medical attention and get tested for the disease. Symptoms include:
- Tightening and swelling of the skin, typically starting with the legs, moving to the arms, and sometimes the trunk
- Thickening of the skin around the joints, restricting movement
- Skin which feels “woody” and has a texture similar to that of an orange peel
- Red or dark patches of skin
- Burning, itching, and/or sharp pains in affected areas
- Fluctuating hypertension preceding the appearance of skin lesions
- Symmetrical skin lesions, commonly on the ankles and thighs and between the wrists and upper arms
- Muscle weakness
- Deep bone pain in the hips and ribs
- Calcification of soft tissues
- Yellow plaques near the eyes
If you have kidney disease or impaired renal function you should always question having a MRI / MRA with contrast to make sure the contrast being used is not one of the ones listed above. When asked if you are allergic to any medications you should say “Yes, Gadolinium!”
Currently, there are federal lawsuits pending in the United States against the drug manufacturers: Bayer Healthcare, Bracco, GE Healthcare and Mallinckrodt due to the possibility that they have not properly informed patients and doctors regarding the dangerous side effects of these drugs.
Over 250 federal lawsuits have been consolidated in a Multidistrict Litigation (MDL) in the Northern District of Ohio, and at least another 104 cases have been filed in various state courts. The purpose of the MDL is to prevent inconsistent pretrial rulings, avoid duplicity and serve the convenience of the parties, witnesses and the Court. Under the MDL rules, if the cases do not settle or resolve during pretrial, they will be returned to the court in which they were filed.
Attorneys representing persons suffering from NSF have been pushing for aggressive scheduling deadlines to move the cases quickly to trial or settlement, as most of the people are very sick and many may not survive a lengthy trial.
If you have been diagnosed with NSF or NFD you should contact Law Offices of Gary Green toll free at 1-888-442-7947 or send us an e-mail at ggreen@gGreen.com to discuss your legal options without obligation.