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Gadolinium Contrast Dye Lawsuits, Nephrogenic Systemic Fibrosis
(NSF)
Lawsuits, and Nephrogenic Fibrosing Dermopathy Lawsuits
Gadolinium is a rare earth metal that can
be put into dyes and injected into the blood stream to
enhance MRI and MRA images. Unfortunately, the use of
Gadolinium dyes in people can cause nephrogenic systemic
fibrosis (NSF) in patients with kidney problems. Nephrogenic
Systemic Fibrosis is a debilitating and potentially fatal
disease for which there is no known cure. Even
though some pharmaceutical companies knew about the
life-threatening side effects of Gadolinium as early as
April 2006, they hid the potential problems caused by the
use of Gadolinium in dyes. Though they sold more
products, the continued use of dyes with Gadolinium has
likely unnecessarily injured and killed many people.
If you or a loved one has been injected
with a gadolinium dye or have recently been diagnosed with
Nephrogenic system fibrosis,
please feel free to e-mail Texas
Gadolinium Dye Lawyer Jason
Coomer with your name & contact
information or use our online
form for a free case evaluation.
Gadolinium Contrast Dyes and Enhancement of MRIs and
MRAs
Gadolinium is a silvery-white, malleable
and ductile rare-earth metal with a metallic luster.
It has unique properties in that it crystallizes in
hexagonal, close-packed alpha form at room temperature, but
when heated to 1508 K or more, it transforms into its beta
form, which has a body-centered cubic structure.
Gadolinium is the active ingredient in
several different brands of contrast dyes used to enhance
MRI and MRA images. In April of 2006, reports began to
surface that certain patients that had been injected with
gadolinium contrast dyes were developing nephrogenic
systemic fibrosis (NSF), previously known as nephrogenic
fibrosing dermopathy (NFD). NSF is a disease which causes a
thickening of the skin, connective tissues, muscles and
internal organs throughout the body. There is no known
treatment for NSF, it becomes worse over time and can lead
to death.
Gadolinium demonstrates a magnetocaloric
effect whereby its temperature increases when it enters a
magnetic field and decreases when it leaves the magnetic
field. The effect is considerably stronger for the
gadolinium alloy. These properties allow Gadolinium
when injected into the bloodstream to enhance MRI and MRA
images. As such, Gadolinium has been put into dyes and
these contrast dyes have been used by scientists and medical
professionals in testing of patients.
Gadolinium Contract Dye and Nephrogenic System
Fibrosis Lawyers
When Gadolinium is injected into a
person, it can cause nephrogenic systemic fibrosis (NSF)
which is a debilitating and potentially fatal disease for
which there is no known cure. Persons with kidney
problems should avoid any dyes with Gadolinium and should be
aware of this potential danger if they are having an MRI or
MRA done.
Nephrogenic systemic fibrosis (NSF) or
Nephrogenic fibrosing dermopathy is a rare and serious
syndrome that involves fibrosis of skin, joints, eyes, and
internal organs. Scientific research has recently discovered
an association between nephrogenic system fibrosis with
exposure to gadolinium in patients with severe kidney
failure.
In NSF, patients develop large areas of
hardened skin with fibrotic nodules and plaques. Flexion
contractures with an accompanying limitation of range of
motion can also occur. NSF resembles scleromyxedema at the
histologic (microscopic) level; it shows a proliferation of
dermal fibroblasts and dendritic cells, thickened collagen
bundles, increased elastic fibers, and deposits of mucin.
People that have had MRIs and are having
unexplained symptoms including skin hardening, fibrotic
nodules, strange lesions, deep pain, joint pain, and
inability to walk or use of their joints, should contact their
doctors to determine if they have Nephrogenic systemic
fibrosis (NSF), Nephrogenic fibrosing dermopathy, or renal
insufficiency. If you have questions about a potential
Nephrogenic Systemic Fibrosis law suit, feel free to contact
Nephrogenic System Fibrosis Lawyer Jason
Coomer with your name, questions, & contact
information.
Nephrogenic System Fibrosis Information
Most patients with NSF have undergone
hemodialysis for renal failure, some have never undergone
dialysis and others have received only peritoneal dialysis.
Many patients have taken immunosuppressive medications and
have other diseases, such as hepatitis C. Four of the five
FDA-approved gadolinium contrast agents have been
principally implicated in potentially causing nephrogenic
systemic fibrosis including Omniscan, Multihance, Magnevist,
and OptiMARK.
People with Nephrogenic System Fibrosis
describe symptoms including swelling and tightening of the
skin, skin thickening, joint pain & problems with range of
motion, muscle weakness, and severe deep pain. The
health problems usually are limited to the extremities of
the body, but also may include the torso. The condition may
develop suddenly over a period of days to several weeks or
more slowly. In many cases, the skin thickening inhibits the
range of motion and extension of joints. Severely affected
patients may be unable to walk, or fully extend the joints
of their arms, hands, legs, and feet. Complaints of muscle
weakness and severe pain are common.
In people with nephrogenic system
fibrosis, their skin changes may start as reddened or
darkened patches, papules, or plaques. In time, their skin
may feel hard or wooden and their skin texture may resemble
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 have been reported. Some patients have reported
yellow papules or plaques on or near their eyes. Rapid, new
onset fluctuating hypertension of unknown cause has been
described prior to the onset of the skin lesions.
Nephrogenic System Fibrosis History
The first cases of NSF were identified in
1997, but NSF was first described as an independent disease
entity in 2000. While skin involvement is on the
foreground, the process may involve any organ and resembles
diffuse scleroderma or systemic sclerosis. In 2006, the link
between NSF and gadolinium-containing contrast agents was
made. As a result, gadolinium-containing contrast is now
considered contraindicated in patients with an estimated
glomerular filtration rate (a measure of renal function)
under 60 and especially under 30.
The European Medicines Agency has
classified the gadolinium-containing contrast agents in
three groups:
-
Least likely (safest) to release free
gadolinium ions Gd3+ in the body have a cyclical
structure: Dotarem, Gadovist and ProHance
-
Intermediate have an ionic linear
structure: Magnevist, MultiHance, Primovist and Vasovist
-
Most likely to release Gd3+ have a
linear non-ionic structure: Omniscan and OptiMARK
It is believed that the pharmaceutical
companies knew about the above listed life-threatening side
effects of using Gadolinium Contrast Dyes to enhance MRI and
MRA images, but hid this research to protect their profits.
Nephrogenic System Fibrosis Lawyers and NSF Lawsuits
Nephrogenic Systemic Fibrosis (NSF), also
known as nephrogenic fibrosing dermopathy (NFD), is a
condition that, so far, has occurred only in people with
renal problems. Until recently it was not known what causes
NSF and there were no cases identified prior to 1997.
It is believed that the pharmaceutical
companies knew about the above listed life-threatening side
effects of using Gadolinium Contrast Dyes to enhance MRI and
MRA images, but hid this research to protect their profits.
They also should have been aware of safer alternatives for
Gadolinium Contrast Dyes.
Gadolinium Contrast Dye Lawyers and FDA Action
The U.S. Food and Drug Administration
(FDA) has asked manufacturers of Gadolinium-Containing
Contrast Agents 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).
This FDA Black Box Warning was updated in
April 2007 to alert health care professional of the FDA’s
request for new warnings about risk of nephrogenic systemic
fibrosis (NSF) to the full prescribing information for all
gadolinium-based contrast agents (GBCAs) (Magnevist,
MultiHance, Omniscan, OptiMARK, ProHance). This new labeling
highlights and describes the risk for NSF following exposure
to a GBCA in patients with acute or chronic severe renal
insufficiency (a glomerular filtration rate <30 mL/min/1.73m2)
and patients with acute renal insufficiency of any severity
due to the hepato-renal syndrome or in the peri-operative
liver transplantation period. In these patients, avoid the
use of a GBCA unless the diagnostic information is essential
and not available with non-contrast enhanced magnetic
resonance imaging. NSF may result in fatal or debilitating
systemic fibrosis. Requested changes to GBCA product
labeling are summarized below. This black box warning was
ordered in May 2007 and applies to all gadolinium dyes.
FDA Boxed Warning
* Exposure to GBCAs increases the risk
for NSF in patients with: o acute or chronic severe renal
insufficiency (glomerular filtration rate <30 mL/min/1.73m2),
or o acute renal insufficiency of any severity due to the
hepato-renal syndrome or in the perioperative liver
transplantation period.
* NSF is a debilitating and sometimes
fatal disease affecting the skin, muscle, and internal
organs.
* Avoid use of GBCAs unless the
diagnostic information is essential and not available with
non-contrast enhanced magnetic resonance imaging (MRI).
* Screen all patients for renal
dysfunction by obtaining a history and/or laboratory tests.
* When administering a GBCA, do not
exceed the dose recommended in product labeling. Allow
sufficient time for elimination of the GBCA prior to any
readministration.
Additional New Warnings:
* Among the factors that may increase the
risk for NSF are repeated or higher than recommended doses
of a GBCA.
* For patients receiving hemodialysis,
healthcare professionals may consider prompt hemodialysis
following GBCA administration in order to enhance the
contrast agent's elimination. However, it is unknown if
hemodialysis prevents NSF.
* Determine the renal function of
patients by obtaining a medical history or conducting
laboratory tests that measure renal function prior to using
a GBCA.
* The risk, if any, for developing NSF
among patients with mild to moderate renal insufficiency or
normal renal function is unknown.
* Post-marketing reports have identified
the development of NSF following single and multiple
administrations of GBCAs. These reports have not always
identified a specific agent. Where a specific agent was
identified, the most commonly reported agent was Omniscan,
followed by Magnevist and OptiMARK. NSF has also developed
following the sequential administration of Omniscan and
MultiHance and Omniscan and ProHance. The distribution of
the number of reports for the individual GBCAs may relate to
multiple factors, including more limited use of some GBCAs,
under-reporting of NSF, characteristics of the agent and a
lack of patients’ complete GBCA exposure history.
FDA Recommendations and Considerations for Healthcare
Professionals:
* Become familiar with the patient
populations who are at known risk for NSF. To date, NSF has
only been identified in patients with: o acute or chronic
severe renal insufficiency (glomerular filtration rate <30
mL/min/1.73m2); o acute renal dysfunction due to the hepato-renal
syndrome or in the perioperative liver transplantation
period.
* Avoid using a GBCA in patients with
known risks for developing NSF unless the diagnostic
information is essential and can not be obtained with
non-contrast enhanced MRI or other diagnostic procedures.
* Prior to administering a GBCA, evaluate
patients for renal dysfunction by assessing their renal
function, either by obtaining a medical history or
conducting laboratory tests that measure renal function.
* When administering a GBCA, do not
exceed the recommended GBCA dose in product labeling and
allow a sufficient period of time for elimination of the
agent from the body prior to any GBCA readministration. The
elimination characteristics of each GBCA are described in
the product label for each GBCA.
* For patients receiving hemodialysis,
consider prompt hemodialysis after administration of a GBCA.
Published data indicate that hemodialysis enhances GBCA
elimination. From the first to the third hemodialysis
session, reported average GBCA clearance rates were 78%,
96%, and 99%, respectively.1 Whether hemodialysis prevents
NSF is unknown.
* Report possible cases of NSF to the FDA
through the FDA’s MedWatch program (see reporting
information at the bottom of this page).
FDA Information for the patient:
Physicians who are considering a GBCA for
use in a patient who is at risk for NSF should discuss the
following with the patient:
* The possibility of developing NSF, a
debilitating and potentially fatal disease that involves the
skin, muscle and internal organs.
* The signs and symptoms of NSF, which
include:
* For the skin—burning or itching,
reddened or darkened patches; and/or skin swelling,
hardening and/or tightening o For the eyes—yellow raised
spots on the whites of the eyes o For the bones, joints and
muscles—joint stiffness; limited range of motion in the
arms, hands, legs, or feet; pain deep in the hip bone or
ribs; and/or muscle weakness
* If the patient is receiving
hemodialysis: Prompt hemodialysis immediately after
administering a GBCA hastens its elimination. However,
whether hemodialysis prevents or reduces the risk of NSF is
unknown.
* After receiving a GBCA, those patients
known to be at risk for NSF require clinical follow-up and
long term monitoring for the disease.
FDA Background Information and Data
First identified in 1997, NSF has been
reported only in patients with acute or chronic severe renal
insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
or patients with renal dysfunction due to the hepato-renal
syndrome or in the perioperative liver transplantation
period. Patients with this condition develop fibrosis of the
skin and connective tissues throughout their body. The skin
thickening may inhibit flexion and extension of joints
resulting in contractures. In addition, patients may develop
widespread fibrosis of other organs. A skin biopsy is
necessary to confirm the diagnosis. The condition may be
debilitating or cause death. Its cause is unknown and there
is no consistently successful treatment.
Five GBCAs (Magnevist, MultiHance,
Omniscan, OptiMARK, and ProHance) are approved in the U.S.
for magnetic resonance imaging (MRI). The GBCAs are
sometimes used for MRA (magnetic resonance angiography)
although none are FDA-approved for MRA. The administered
dose of the contrast with magnetic resonance angiography (MRA)
may be higher (up to three times) than the approved dose for
MRI. NSF has been reported following administration of all
five FDA approved gadolinium-based contrast agents (Magnevist,
MultiHance, Omniscan, OptiMARK, and ProHance). However, some
adverse event reports of NSF do not include complete
information on patients’ GBCA exposure history. Also,
reports indicate that some patients received more than one
GBCA prior to a NSF diagnosis. The lack of complete
information of GBCA exposure, exposure to multiple GBCAs,
along with similarities among all these contrast agents,
make it impossible at present to definitively determine
whether the extent of risks for developing NSF are the same
for all the GBCAs.
Other FDA Information
In June 2006, FDA first notified
healthcare professionals and the public about the risk of
NSF following exposure to GBCAs after receiving reports of
25 patients with NSF from the Danish Health Authority. FDA
issued additional information to healthcare professionals
and the public in December 2006.
FDA review of spontaneously submitted
post-marketing reports, sponsor-supplied information and the
published literature identifies the following:
* FDA has received reports of patients
who developed NSF after exposure to Magnevist, MultiHance,
Omniscan, OptiMARK, and ProHance, unspecified GBCA, and
multiple GBCAs (following multiple GBCA enhanced MRI scans).
* Among the reports that included renal
status information, all patients had acute or chronic severe
renal insufficiency, renal dysfunction due to the hepato-renal
syndrome or renal dysfunction in the perioperative liver
transplantation period. The vast majority of patients were
receiving hemodialysis.
* To date, there has not been a report of
NSF in a patient with normal renal function or mild to
moderate renal insufficiency following GBCA exposure.
* The reported time between receiving a
GBCA and subsequent diagnosis of NSF diagnosis is highly
variable. Reported times range between days to many months.
* FDA has received reports of patients
who died from complications related to NSF.
FDA has requested the manufacturers of
the GBCAs to revise the product labels as soon as possible
to include a new boxed warning and new Warnings section that
describes the risk of NSF.
Gadolinium Lawyers and Nephrogenic System Fibrosis
Lawyers
If you or a person you love has been
injected with a gadolinium dye for an MRI and have
Nephrogenic System Fibrosis,
please feel free to e-mail Texas
Nephrogenic System Fibrosis Lawyer Jason
Coomer with your name & contact
information or use our online
form for a free case evaluation.
Texas Gadolinium Attorney Jason
Coomer commonly works with other lawyers throughout the
United States on Gadolinium Lawsuits and Nephrogenic System
Fibrosis Lawsuits. He works with Houston Gadolinium Lawyers,
New York Nephrogenic System Fibrosis Lawyers, Dallas NSF Lawyers,
Boston Gadolinium Dye Lawyers,
and Los Angeles Contrast Dye Lawyers. By
sharing information and working together, his law firm and
other firms throughout the United States are able to provide better
representation for there clients.
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