
Gadolinium-Enhanced
MRI and MRA Scans Linked to Nephrogenic Systemic Fibrosis (NSF)
or Nephrogenic Fibrosing Dermopathy (NFD)
FDA ALERTS PHYSICIANS: Gadolinium-based contrast
dye may cause fatal disease affecting the kidneys, skin, muscles,
joints, and other internal organs.
On this Page:
FDA Recommends “Black Box” Warnings
On May 23, 2007, the Food and Drug Administration
(FDA) recommended that manufacturers of all Gadolinium-based
contrast agents add “black box” warnings about the
risk of patients developing nephrogenic systemic fibrosis (NSF),
also known as nephrogenic fibrosing dermopathy (NFD).
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Who may be injured?
Patients
are exposed to Gadolinium during MRI (magnetic resonance imaging)
and MRA (magnetic resonance angiogram) medical procedures. Gadolinium
is used to improve the visibility of internal organs. Recent
studies show increased risk for patients with end stage
renal disease (ESRD), kidney
dialysis patients with chronic or acute renal insufficiency
due to hepato-renal syndrome (liver/kidney disease),
and patients who have had liver transplants. Patients
with kidney disease or who are on kidney dialysis are at increased
risk because Gadolinium is mainly eliminated from the body through
the kidneys.
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Symptoms of NSF/NSD
- Thickening, swelling and tightening of the skin, usually
starting in the legs, but also including the muscles of the
thigh and lower abdomen, diaphragm, arms, hands, and lungs
- Reddened or darkened patches on the skin
- Burning or itching on the skin
- Yellow raised spots on the whites of the eyes
- Difficulty bending the joints
- Muscle weakness
- Deep pain in the hip bones or ribs
- Scarring and thickening of internal organs, leading to organ
failure and death
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Gadolinium MRI Contrast Product Names
Between 1988 and 2004 there have been
five FDA-approved Gadolinium MRI contrast agents (also called
GBCA), all of which could cause problems:
- Onmiscan (gadodiamide)
- MultiHance (gadobenate dimeglumine)
- Magnevise (gadopentetate dimeglumine)
- ProHance (gadoteridol)
- OptiMARK (gadoversetamide)
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Contact Your Doctor!
If you or someone you know has
had a Gadolinium-enhanced MRI or MRA, you should contact your
doctor immediately, especially if you have kidney or liver
problems.
The time between a patient undergoing
an MRI with Gadolinium and developing NSF varies from several
days to several months. NSF can cause severe disability
or even death, making it even more important to seek medical
help immediately.
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Contact Kershaw, Cutter & Ratinoff
The attorneys of Kershaw, Cutter & Ratinoff,
LLP, have handled hundreds of cases involving
dangerous and defective medical products, such as Gadolinium. We understand that
such complex cases demand the knowledge and skill of experienced
attorneys. Our years of experience give you the advantage
to prove up your case, even under the most difficult circumstances.
If you or someone you know has been exposed
to Gadolinium, and may have developed NSF or NFD, especially
if you have kidney disease, the experienced attorneys of Kershaw,
Cutter and Ratinoff can help. Please contact
us for
a free case evaluation.
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Injured plaintiffs, businesses, and
consumers throughout the nation rely on Kershaw,
Cutter & Ratinoff for excellent representation
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Copyright © 2008 Kershaw, Cutter & Ratinoff LLP.
All Rights Reserved.
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Gadolinium
MRI: Safe if I have kidney problems?
MayoClinic.com — June 11,
2007
FDA
requests "black box" warning on gadolinium contrast
packaging
Diagnostic Imaging Online
— May 31, 2007
FDA
Orders Black Box Warning for Gadolinium-Based Contrast Agents
MedPage Today — May
23, 2007
FDA Information:
Information
on Gadolinium-Containing Contrast Agents
FDA Web Site 2007
Information
for Healthcare Professionals
Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging
FDA Web Site 2007
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