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GADOLINIUM CLAIMS
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What is gadolinium?
Gadolinium is an FDA-approved contrast agent for magnetic resonance imaging
(MRI). It provides greater contrast between normal tissue and abnormal tissue
in the brain and body. Gadolinium 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) and easy to see on the
MRI.
Does gadolinium go by other names?
Gadolinium is also called gadolinium-DPTA and gadodiamide, and it goes by
various brand names, depending on the pharmaceutical company that makes it:
What
is the problem with gadolinium?
The FDA is evaluating a causal connection between gadolinium-containing
contrast agents and a disease known as Nephrogenic Systemic Fibrosis
(NSF) also called Nephrogenic Fibrosing Dermopathy (NFD)
that occurs in patients with kidney failure.
Reports have
identified a possible link between NSF/NFD and exposure to gadolinium
containing contrast agents used at high doses for a procedure called Magnetic
Resonance Angiography (MRA). An MRA test uses magnetic resonance imaging to
take pictures of blood vessels. The gadolinium contrast agent is injected into
a patient's vein in order to distinguish blood vessels from other nearby
tissues.
The 25 cases of NSF/NFD were reported on May 29, 2006, by the Danish Medicines
Agency. Among these, 20 cases occurred in Denmark and five cases occurred in
Austria. The patients developed NSF/SFD within 3 months (range 2 weeks to 3
months) after receiving the gadolinium-containing contrast agent.
Signs and Symptoms of NFD
Typically there is swelling and tightening of the skin, usually limited to the
extremities, but sometimes involving the trunk. The condition may develop over
a period of days to several weeks. In many cases, skin thickening inhibits the
flexion and extension of joints, resulting in contractures. Severely affected
patients may be unable to walk, or fully extend the joints of their arms,
hands, legs, and feet. Complaints of muscle weakness are common. Approximately
5% of patients have a rapidly progressive (fulminant) course.
The skin changes may start as reddened or darkened patches, papules, or
plaques. In time, the skin may feel "woody" and the surface may resemble the
texture of the peel of an orange. Patients may experience burning, itching, or
severe sharp pains in areas of involvement. Radiography may reveal
calcifications of the soft tissue. Deep "bone pain" has been described
in the hips and in the ribs.
The skin lesions are commonly symmetrical, with zones between the ankles and
thighs most commonly involved, followed by involvement between the wrist and
upper arms. Hand and foot swelling with blister-like lesions has also been
reported. Some patients have reported yellow papules or plaques on or near the
eyes. Rapid, new onset fluctuating hypertension of unknown cause has been
described prior to the onset of the skin lesions.
No consistently effective treatment for NFD
There is no consistently successful treatment for NSF, although many
things have been tried with varying results. Source: Cowper SE.
Nephrogenic Fibrosing Dermopathy [NFD/NSF Website]. 2001-2006. Available at
http://www.icnfdr.org. Accessed October 13, 2006.
Do I have a case?
If you have you have been diagnosed with NSF or NFD, you probably have a case. Please call us at 877-220-2203 or click on the links below if you would like more information about your claim.