Nephrogenic Systemic Fibrosis (NSF) is a rare but
potentially fatal degenerative disease of the skin and
internal organs. First identified in 1997, it occurs only
in a few patients -- those who have a serious kidney
disease and have undergone magnetic resonance imaging (MRI)
or magnetic resonance angiography (MRA) tests. Many
scientists believe NSF is caused by exposure to gadolinium,
a chemical used as a dye in MRI/MRA tests. In fact, one
study showed that more than 95 percent of NSF patients had
been exposed to some type of gadolinium within three months
of contracting the disease. In response, the FDA has
already recommended that doctors avoid gadolinium, and
MRI/MRAs in general, in patients with kidney failure.
Researchers in the United States and Europe are working to
determine whether the substance should be banned altogether.
Scientists believe gadolinium may cause NSF because it
reacts badly to high levels of acid in the body. Because
patients with kidney failure aren't able to process
impurities out of their blood as well as healthy people,
they have a much higher level of acid in their bodies, a
condition known as acidosis. The brand names of
gadolinium-containing dyes that are approved for use in the
United States with MRIs include:
* Magnevist
* MultiHance
* Omniscan
* OptiMARK
* ProHance
Brand names of gadolinium-containing dyes used in other
countries include Dotarim, Gadovist, Primovist and Vasovist.
Painful, Debilitating Symptoms
NSF was originally called nephrogenic fibrosing dermopathy,
because its first and most obvious symptoms are lesions or
rough patches on the patient's skin. Over a period of days
to weeks, patients notice a swelling and tightening of the
skin, especially the skin on the arms, hands, legs and
feet. This is often symmetrical, meaning that a spot on the
patient's right arm will appear in a similar place on the
left arm. The skin develops lesions -- areas where it gets
redder or darker, which burn, itch or send sharp pains
through the area. On a microscopic level, scientists have
found that these lesions are caused by a buildup of too
much skin and connective tissue -- essentially, scar tissue.
Over time, the lesions harden and become "woody,"
resembling an orange peel. Eventually, this hardening makes
it impossible for patients to bend their fingers, elbows,
knees or other joints -- robbing patients of their ability
to walk, perform daily tasks or even care for themselves.
And the disease attacks other organs in the same way,
leading to a buildup of scar tissue that could eventually
stop internal organs from working as well, causing death.
* In addition to these symptoms, NSF patients have also
reported: Blister-like spots on the hands
* Muscle weakness
* Bone pain in the hips and ribs
* Yellow lesions on or near the eyes
* Sudden development of hypertension (high blood pressure)
Confounding Diagnoses
Because NSF is only found in patients who already have
kidney failure, its symptoms are often disguised by
existing symptoms of a serious disease. Indeed, some
scientists believe that NSF is underdiagnosed in kidney
patients. In addition, NSF is often found about two weeks
after the patient underwent a serious medical problem or a
surgery, such as failure of a transplanted kidney,
deep-vein thrombosis, angioplasty or another traumatic
event that affects the blood vessels and the heart.
Researchers are currently investigating whether these
traumas cause NSF or are some of its effects. Many of them
would be treated or diagnosed with MRI/MRA tests,
suggesting that the tests -- and their use of gadolinium --
could be the problem.
Crippling Effects
Even if it didn’t affect patients' independence, NSF
would be disabling because of its painful and disfiguring
effects on the skin. But because it also causes muscle
weakness, joint pain and physical inflexibility in patients
who already have serious kidney problems, NSF can be
literally crippling, putting some patients in a wheelchair
within weeks of diagnosis. In severe cases, patients may
need assistance just to move, care for themselves and
perform the daily tasks of living. For people who have
fought hard to live independent lives after renal failure,
this can be emotionally devastating as well. And NSF
presents a very real threat of death: directly, through
buildup of scar tissue on vital internal organs, or
indirectly, through falls and accidents caused by the
patient's loss of mobility. That’s just too high a
price to pay for a simple diagnostic test.
As of December 21, 2006, the U.S. Food and Drug
Administration knew of at least 215 cases of NSF worldwide.
Of these, all of the patients whose medical histories were
reviewed in detail had been exposed to gadolinium in an MRI
or MRA. In addition, tests have found gadolinium in the
skin lesions of people with NSF. While more research is
needed to confirm these findings, this very strong
correlation between gadolinium and NSF has already led to
lawsuits across the country. As researchers begin to
confirm the link between NSF and gadolinium, observers
expect many more.
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