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DISCLAIMER
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Pharmaceutical Injuries - Gadolinium
Have You Sustained Personal Injuries from
Medications, Pharmaceuticals, or Chemical Exposure?
Gadolinioum,
a chemical used to help treat diseased kidneys, causes a painful and
incurable disease known as Nephrogenic System Fibrosis (NSF) or Nephrogenic
Fibrosing Dermopathy (NFD), which hardens the skin. Gadolinium, a heavy
metal, is injected into patients to help doctors capture medical images. The
drug, manufactured by Bayer Corp., is distributed by McKesson Corp. and other
companies. A recent warning from the Food and Drug Administration relates to
NSF. The FDA has asked manufacturers of all Gadolinium-based contrast agents
to include a new boxed warning on the product label. As more and more people are
becoming aware of the dangers of Gadolinium-containing contrast agents, more
reports of these serious conditions are surfacing. People who develop NSF or
NFD may experience a thickening of the skin and other organs, which can limit
their ability to move, extend joints and can lead to significant pain and
even death. Other problems may include dark patches on the skin that appear
rough and hard with raised plaques or papules, which are elevations of the
skin. Joint and bone pain, as well as swelling of the feet and hands have
also been reported.
The FDA
first warned about NSF and NFD associated with Gadolinium in June 2006 and
again in December 2006. As of April 2007, the FDA had received a considerable
number of additional cases involving these problems.
FDA
Requests Boxed Warning for Contrast Agents Used to Improve MRI Images
The U.S.
Food and Drug Administration (FDA) has asked manufacturers to include a new
boxed warning on the product labeling of all gadolinium-based contrast agents
which are used to enhance the quality of magnetic resonance imaging (MRI).
The
requested warning would state that patients with severe kidney insufficiency
who receive gadolinium-based agents are at risk for developing a
debilitating, and a potentially fatal disease known as nephrogenic systemic
fibrosis (NSF). In addition, it would state that patients just before or just
after liver transplantation, or those with chronic liver disease, are also at
risk for developing NSF if they are experiencing kidney insufficiency of any
severity.
Patients
with NSF develop thickening of the skin and connective tissues that inhibits
their ability to move and may result in broken bones. Other organs are at
risk of thickening as well. The cause of NSF is not known and there is no
consistently effective treatment of this condition.
FDA first
notified health care professionals and the public about the
gadolinium-related risks for NSF in June 2006. Information on the risks was
updated in December.
Gadolinium-based
contrast agents are commonly used to improve the visibility of internal
structures when patients undergo an MRI. Five gadolinium-based contrast
agents have been approved for use in the United States:
Magnevist (gadopentetate dimeglumine)
Ominiscan (gadodiamide)
OptiMARK (gadoversetamide)
MultiHance (gadobenate dimeglumine)
Prohance (gadoteridol)
Reports have identified the development of NSF following single and multiple
administrations of the gadolinium-based contrast agents. The reports have not
always identified a specific agent. Omniscan was the most commonly reported
agent, when a specific agent was identified, followed by Magnevist and
OptiMARK.
NSF also
has developed after the sequential administration of Omniscan and MultiHance
and Omniscan and ProHance. Because reports incompletely describe exposure to
gadolinium-based contrast agents, it is not possible to know if the extent of
risks for developing NSF is the same for all agents.
Patients
should be screened for kidney problems prior to receiving one of these
imaging agents. The recommended dose should not be exceeded and enough time
should elapse to ensure that a dose has been eliminated from the body before
the agent is used again.
There have
been no reports of NSF among patients with normal kidney function or those with
mild-to-moderate kidney insufficiency.
Gadolinium
is an FDA-approved contrast agent for magnetic resonance imaging (MRI).
Gadolinium is also called gadolinium-DPTA and gadodiamide, and it goes by
various brand names. Gadolinium is non-radioactive and resembles plain water.
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.
NSF/NFD is
typically characterized by 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 painful
contractures. In the most severe of cases, 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.
Once a
patient contracts NSF/NFD, the skin changes may start as reddened or darkened
patches, papules, or plaques. In time, the skin surface may distort to
resemble the texture of the peel of an orange. Some patients may experience
burning, itching, or severe sharp pains in areas of involvement. Radiography
may reveal calcifications of the soft tissue. NSF/NFD patients can report
"bone ache" described in the hips and in the ribs.
Topically,
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 in patient with NSF/NFD. Some patients have reported yellow papules
or plaques on or near the eyes.
A single
U.S. District Court in Cleveland, Ohio has been assigned to handle the
discovery phase of all patient injury lawsuits filed in federal courts
related to gadolinium and nephrogenic systemic fibrosis (NSF). The move is
expected to speed up the legal process for the cases, and could lead to
either earlier trials or settlement of the litigation.
The U.S.
District Court for the Northern District of Ohio under Judge Dan Polster will
oversee the discovery process, with discovery for all federal gadolinium/NSF
lawsuits centralized to take place in that jurisdiction. The move is fairly
common for cases in which multiple plaintiffs have filed suit against a small
number of defendants. The MDL it will streamline the litigation process and
enable both plaintiffs and defendants to go through the discovery process
once per defendant, rather than for every individual case.
If
you or a loved one had an MRI/MRA using a contrast agent to enhance the
image, and you developed NFS/NFD, we would be pleased to provide a free,
confidential evaluation.
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Get
The Facts on
Personal Injury
Injuries to one's person can occur in
numerous different ways. In addition to car
& automobile accidents, there are many other examples of situations
that would provide a legal basis for personal injury claims. These include negligence towards others, as in medical malpractice claims and patient neglect in nursing home and healthcare
facilities. Additionally, any person or business can be negligent of
adequatley maintaining their property which may result in slips and falls or other accidents; and
criminal incidents that may occur because of negligent security. Also, people
can be injured as the result of intentional attacks, such as in the cases of dog bites or assault
and battery.
Injuries to property can happen due
to theft/vandalism, embezzlement, and negligence,
while injuries to one's reputation typically occurs as the result of libel or slander.
When a person suffers an injury to
his person, rights, reputation, or property, they may be entitled to
compensation and should consult a lawyer immediately. In addition to Personal
Injury claims needing to be filed within specified time periods, over
time, critical evidence can dissipate making claims harder to prove.
An injured party may be entitled to
recover damages for loss of earnings capacity, pain and suffering, and
reasonable medical expenses, including both current and projected future
losses.
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