MRI with Contrast Dye Risks for Kidney Patients

September 10, 2008

MRI with Contrast Dye Risks for Kidney Patients

Risk for Developing NSF Higher for Dialysis Patients and ESRD

So far, NSF has only developed in patients with renal or kidney impairment, kidney failure, renal failure, kidney disease and persons with decreased renal or urine output. Although the cause of NSF has not yet been discovered, medical research has confirmed that NSF can be triggered by exposure to gadolinium found in certain contrast dyes used with MRI and MRA exams. These MRI contrast dyes are referred to as gadolinium-based contrast agents (GBCAs).

The following MRI patients are believed to be at high risk for developing NSF if they are exposed to gadolinium dyes;

• Patients with severe kidney insufficiency;
• Kidney Patients on Dialysis
• Kidney Patients with End Stage Renal Failure / ESRD
• Patients just before or after liver transplantation; 
• Patients just before or after kidney transplant; 
• Patients with kidney insufficiency;
• Patients with chronic liver disease;
• Patients with other kidney diseases & kidney or renal failures.

Kidney Patients and NSF Lawsuit

If you had a MRI or MRA with a Gadolinium-based contrast dye was used to enhance the MRI image and you have been diagnosed with Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), or currently suffer from MRI related skin problems to hands, arms, feet, ankles, legs, thighs body and truck including: skin tightening, muscle contractures, dark botches of skin, reddened areas of skin, thickened areas of skin or lesion like disorders, hip pain, bone pain, rib cage pain, severe joint problems, kidney failure, or renal failure, then you may be eligible to file a MRI NSF Lawsuit.

If you have not already been diagnosed with NSF and NFD, then we can assist in MRI side effects testing and skin biopsy / punch biopsy testing. Call us to discuss your MRI side effects symptoms and conditions. Talk to a Board Certified Personal Injury Trial Lawyer to discuss possible legal options available to you. All cases taken on a Contingency Fee Basis! Call Toll Free 1-800-883-9858.

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Causes of NSF

Gadolinium Exposure Causes NSF

The exact cause of NSF is still unknown, but research has confirmed that exposure to gadolinium dyes triggers the disease in certain patients. So far, NSF has only occurred in people with kidney disease. Neither the duration of kidney disease nor its underlying cause are related to the development of NSF. Patients have developed NSF in the earliest and latest stages of kidney disease.

Case studies have revealed that the following events have occurred prior to the onset of NSF in some patients:

• Thrombotic episode (i.e., deep venous thrombosis);
• Recent surgery (particularly vascular surgery,
• Angioplasty of a blood vessel);
• Coagulation abnormalities (blood clotting);
• Recent failure of a transplanted kidney;
• End Stage Renal Disease (ESRD)
• Renal Failure;
• Kidney Cancer & Kidney Failure
• Sudden onset kidney disease with severe swelling of the extremities.

Researchers are currently investigating to see if any of these events could be a trigger for NSF. It is important to note that many of these events are preceded or followed by MRI or MRA exams. So the common denominator linking these events to the development of NSF may just be the gadolinium-based contrast dyes used with the MRI and MRA exams.

Gadolinium Side Effects & NSF Lawsuit

If you had a MRI or MRA with a Gadolinium-based contrast dye was used to enhance the MRI image and you have been diagnosed with Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD) or currently suffer from MRI related skin problems to hands, arms, feet, ankles, legs, thighs body and truck including: skin tightening, muscle contractures, dark botches of skin, reddened areas of skin, thickened areas of skin or lesion like disorders, hip pain, bone pain, rib cage pain, severe joint problems, kidney failure, or renal failure, then you may be eligible to file a MRI NSF Lawsuit.

If you have not already been diagnosed with NSF and NFD, then we can assist in MRI side effects testing and skin biopsy / punch biopsy testing. Call us to discuss your MRI side effects symptoms and conditions. Talk to a Board Certified Personal Injury Trial Lawyer to discuss possible legal options available to you. All cases taken on a Contingency Fee Basis! Call Toll Free 1-800-883-9858.

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NSF Registry for Patients with NSF

History of the NSF Registry

The NSF Registry - Data Collection of Nephrogenic Systemic Fibrosis Information & Research. According to the NSF Registry at Yale University (New Haven, CT), the NSF Registry maintains records on over 215 patients with NSF. Of these 215 NSF patients, more than 95% of all NSF patients surveyed have been exposed to a gadolinium within 2-3 months prior to the onset of symptoms of NSF with a majority of those on dialysis. Further, a number of patients with impaired renal function have been reported to the NSF registry.

NSF Registry Gathers Data on NSF

The NSF Registry was formed by Dr. Shawn Cowper to gather and organize information concerning Nephrogenic Systemic Fibrosis (NSF) from patients worldwide. The goal of the NSF Registry is to identify factors that may relate to or cause NSF. Currently the NSF Registry has collected medical data, treatment methods and results of several hundred NSF patients in order to evaluate the current NSF treatment options and hopefully find new and even more effective NSF treatment medications, therapies and strategies in the future.

Contact Information for the NSF Registry
Contacting the NSF Registry by e-mail is the preferred method at: registermc@juno.com

NSF Registry Telephone: (203) 785-3524
NSF Registry Fax: (203) 785-6869

Per the instructions on their website, patients should not send any medical information, tissue samples or slides to the NSF Registry unless directed to do so by Dr. Cowper or Carol Hribko.

Mailing Address: (to send microscope slides)

Carol Hribko
Yale Dermatopathology Service
PO Box 208059
15 York Street, LMP 5031
New Haven, CT. 06520-8059

Testing for NSF

If you would like more information about being tested for NSF and the current methods that are used to evaluate a patient for NSF or NFD, then call us at 1-800-883-9858. Note, we are a law firm in Houston, Texas and can help provide information about NSF punch biopsy testing and other currently methods for diagnosing NSF. We do not actually perform any medical procedures, but can assist in providing the current accepted protocol used by Physicians throughout the United States.

NSF Lawsuit - Free Case Evaluation

If you need more information about your legal rights to a Gadolinium NSF Lawsuit, please call us toll free at 1-800-883-9858 or  visit us online at Gadolinium NSF Lawsuit Evaluation

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MRI Patients on Dialysis & Renal Failure (ESRD)

* MRI Patient with Stage 3 Renal Failure and Possible NSF  - NSF / MRI Patient  50-60 yr old Female

Patient Jane Doe was diagnosed with psorosis of the liver and Hepatitus C in 2004 and is currently has Stage 3 renal failure.  She was diagnosed with fibromyalgia in 2006. MRI patient has had at least 10-15 MRIs with contrast done between 2004 and 2007 and quickly developed red/dark patches of skin (ankles, thighs), rashes (face, neck), burning/itching (whole body), rough textured skin, joint pain/stiffness, pain in her hips/ribs, muscle weakness, and muscle contractures. Doe is meeting with her doctors to discuss MRI - NSF testing with a punch biopsy test is necessary or not.

* Type 2 Diabetic with NSF Skin Problems after MRI with Gadolinium contrast  NSF / MRI Patient  40-50 yr old Male

 Potential NSF client did not have any known kidney or liver problems prior to his MRIs with contrast.  He was diagnosed with Type II Diabetes 4/5 years ago. He had 2 MRIs with contrast done in the late 1990’s (ankle and knee) followed by surgery. While still in therapy after the surgeries, NSF Client  began developing red/dark skin between his ankle and his knee on both legs.  The area also develops a pimply type rash right below the knee.  The area itches.  He has swelling/tightening and hardening/thickening of the skin in the same area.  NSF client suffers from joint pain/stiffness, muscle weakness and muscle contractures. NSF Client is going to go to his primary treating doctor and ask the doctor whether or not NSF punch biopsy testing is needed or not.

Diabetic on Dialysis with NSF MRI Side Effects  NSF / MRI Patient  50-60  yr old Male

 Potential NSF client has been a diabetic for last 20+ years  He has been on dialysis for over 5 years.  He does not have any known liver problems. He had 1 MRI with contrast done in 2006. Since the MRI, he has developed red/dark patches on his legs, swelling/tightening of his skin, hardening/thickening of the skin on his legs, joint pain/stiffness, muscle weakness, and muscle contractures. It is very difficult to walk and must use wheelchair due to the swelling in his legs. NSF Client is going to go to his primary treating doctor and ask the doctor whether or not NSF punch biopsy testing is needed or not.

NSF type symptoms - Skin burning pain, ankle and knee swollen after MRI with contrast.  50-60 yr old Female

Possible NSF patient was diagnosed with Type II Diabetes approximately 1 -2 years ago.  She does not have any known liver problems. She had a MRI w/contrast done of her right leg in 2008. The area on her right leg, between the ankle and the knee is very red and swollen.  She states that the swells to the point where her leg is hard and burns. She is unable to rest her right leg on anything due to the pain from the swelling. Client is meeting with her doctors to discuss MRI - NSF testing with a punch biopsy test is necessary or not.

NSF  Patient with dard red skin, swelling and contractures and muscle weakness  MRI / NSF Client # 2227 - 40-50 yr old Female

MRI / NSF client does not have any known kidney or liver problems.MRI patient had a MRI with contrast done in June 2005. Within 12 to 18 months, she  developed red/dark patches on her face, rashes on her face, back, scalp & legs, burning/itchy skin, swelling/tightening of the skin on her ankles & wrists, joint pain/stiffness in her ankles, muscle weakness in her arms/legs and muscle contractures in her toes and calves. Client is meeting with her doctors to discuss MRI - NSF testing with a punch biopsy test is necessary or not.

NOTE:

All of the above basic fact summaries are provided to help others to read the actual complaints of other MRI victims. No names or identifying facts are provided so as to keep the clients identity private, but enough facts so as to help others in understand problems experienced. If you have had similar skin, muscle or joint problem or reactions following a MRI and would like to get more information about NSF and/or NSF testing, then call us at 1-800-883-9858

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MRI with Gadolinium in Kidney Patients

MRI with Gadolinium in Kidney Patients Increased Risks for NSF

According to new studies, 3% of all MRI patients with pre-exiting renal problems, renal insufficiency or kidney failure that have a MRI or MRA with gadolinium contrast dye, will be later diagnosed with NSF also known as nephrogenic systemic fibrosis.  In an article in the Cleveland Clinic Journal of Medicine, Volume 75 Number 2, Feb 2008, titled: Nephrogenic Systemic Fibrosis and its association with Gadolinium exposure during MRI.

NSF Complications from Gadolinium

The gadolinium NSF complications are serious and potentially deadly. NSF is usually known for its skin tightening, muscle contractures, dark botches of skin, reddened areas of skin, thickened areas of skin or lesion like disorders, hip pain, bone pain, rib cage pain, severe joint problems, kidney failure, or renal failure, muscle pain, yellow spots on eyes but the same fibrosing effect of NSF can effect ones heart, lungs, skeletal muscles and diaphragm leading to serious complications and death.

NSF Lawsuits

If you had a MRI/MRA and a Gadolinium-dye was used to enhance the MRI image, then your health may be at risk. If you developed Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), acne pimple and bumps, unexplained skin problems, skin tightening, leathery or thickened skin, muscle pain, lesions, rashes, hip pain, severe joint problems, then you may be eligible to file a MRI Gadolinium Lawsuit for your injuries. Call us at 1-800-883-9858 to discuss all your legal options.

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September 12, 2007

Gadolinium Dear Doctor Letter

Manufacturers of Gadolinium-based contrast agents issued a Dear Healthcare Professional letter to inform healthcare professionals of the addition of a BOXED WARNING and revisions to the WARNING section of the prescribing information for Gadolinium-based contrast agents used in Magnetic Resonance Imaging (MRI) causing a rare disease called Nephrogenic Systemic Fibrosis (NSF).

Dear Healthcare Professional (Dear Doctor Letter)

The manufacturers of gadolinium-based contrast agents would like to inform you of important revisions to the prescribing information for the products listed in alphabetical order above. Gadolinium-based contrast agents are approved by the U.S. Food and Drug Administration (FDA) for use in magnetic resonance imaging (MRI).

Post-marketing reports show that the use of these agents increases the risk of the development of a serious medical condition called Nephrogenic Systemic Fibrosis (NSF), in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2) and patients with renal dysfunction due to the hepatorenal syndrome or in the perioperative liver transplantation period.

NSF leads to excessive formation of connective tissue in the skin and internal organs. NSF is progressive and may be debilitating or fatal. As of today, the FDA has received reports of over 250 cases of NSF after administration of gadolinium-based contrast agents.

As a result of these NSF cases, the package inserts of all gadolinium-based contrast agents have been revised to include the following Boxed Warning and update to the WARNINGS section. Call 1-800-FDA-1088 (1-800-332-1088)

MRI Contrast Agents

Magnevist® (gadopentetate dimeglumine) Injection

MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL

Omniscan™ (gadodiamide) Injection

OptiMARK® (gadoversetamide) Injection

ProHance® (Gadoteridol) Injection, 279.3 mg/mL

Gadolinium Toxicity Lawsuit - Free Case Evaluation

If you or a loved one had a MRI or a MRA, and a Gadolinium-based contrast dye, medium or agent was used to enhance the MRI image, then your health may be at risk. If you developed Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), skin problems, skin tightening, severe joint problems, kidney failure, or renal failure, then you may be eligible to collect money damages for your injuries. Please contact us by calling 1-800-883-9858 or follow the link below for a free and confidential case evaluation.

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December 22, 2006

FDA’s Gadolinium Q&A

1. What is gadolinium and what is its use in clinical medicine?

Gadolinium is a paramagnetic metal ion. Paramagnetic ions, such as gadolinium, tend to move into magnetic fields. This trait makes paramagnetic ions such as gadolinium useful for Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA). Gadolinium is approved for use with MRI as a contrast agent to provide a clearer picture of body organs and tissues. It is also used for MRA, another imaging procedure.

Gadolinium-containing contrast agents are manufactured by a chelating process, a procedure in which large organic molecules form a stable complex around the gadolinium. The chelate reduces the chances of toxicity that could result from exposure to free gadolinium. This stable complex is eliminated via the kidneys in patients with normal functioning kidneys.

2. What is the difference between MRA and MRI?

MRA is a special type of MRI used to study blood vessels. MRA is utilized to detect, diagnose and aid in the treatment of heart disorders, stroke, and vascular diseases.

3. Can an MRI and MRA be performed without gadolinium-containing contrast?

MRI can be performed without contrast. However, gadolinium-containing contrast agents provide better diagnostic information in many instances as compared to MRI without contrast.

The use of a gadolinium-containing contrast agent to enhance MRA is not FDA approved. MRA is able to provide detailed images of blood vessels without gadolinium-containing contrast. The use of gadolinium-containing contrast agents has been reported to enhance MRA.

4. Are there other approved MRI contrast agents that do not contain gadolinium?

There are no other approved MRI contrast agents. Imaging contrast agents, such as iodinated contrast agents are used in Computed Tomography, plain X-ray and X-ray angiography. However, these iodinated contrast agents require X-ray imaging rather than MRI.

5. What is the concern regarding gadolinium-containing contrast agents?

The information in the May 29, 2006, press release from the Danish Medicines Agency (DMA) and the January 2006 report by Grobner et al in Nephrology, Dialysis and Transplantation describe patients with renal failure who developed a rare, potentially life-threatening condition called Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). The DMA was concerned because all patients received a gadolinium enhanced MRA procedure a few weeks to a few months before developing NSF/NSD.

6. What is Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD)?

NSF/NFD was first described in the medical literature in 2000. The first case of NSF/NFD was seen in 1997. The disease is seen in patients that have noticeably advanced renal failure. The disease causes fibrosis of the skin and connective tissues throughout the body. Patients develop skin thickening that may prevent bending and extending joints, resulting in decreased mobility of joints. In addition, patients may experience fibrosis that has spread to other parts of the body such as the diaphragm, muscles in the thigh and lower abdomen, and the interior areas of lung vessels. The clinical course of NSF/NFD is progressive and may be fatal.

7. What is the treatment for NSF/NFD?

There is no consistently successful treatment for NSF/NFD.

Improving renal function seems to slow or arrest NSF/NFD and may even result in a gradual reversal of NSF/NFD.

8. How many gadolinium-containing contrast agents has FDA approved? Was NSF/NFD seen with all of the U.S.-approved gadolinium-containing contrast agents?

There are five FDA approved gadolinium-containing contrast agents (Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance).

Omniscan is the only approved gadolinium contrast agent in the countries where the Grobner report originated. FDA is actively investigating all gadolinium-containing contrast agents for any possible association with NSF/NFD.

9. Does the gadolinium-containing contrast agent (Omniscan) cause NSF/NFD?

Whether the gadolinium agent causes NSF/NFD is unknown. However, case reports from the DMA are of enough concern that FDA is further investigating a possible link between the condition and administration of gadolinium.

10. Why doesn’t the FDA feel that the evidence for causality between gadolinium-containing contrast agents and the development of NSF/NFD is conclusive?

The evidence associating the administration of a gadolinium-containing contrast agent to NSF/NFD is from case reports in patients with complicated medical histories. Concurrent medical illness and/or use of other medications may be a factor in the development of the condition. Further evaluation of these factors as well as use of gadolinium-containing contrast agents in patients with renal failure and in patients that develop NSF/NFD will be required.

11. What actions will FDA take regarding the new information about gadolinium-containing contrast agent administration and the development of NSF/NFD in patients with advanced renal disease?

FDA is continuing to evaluate these reports, is undertaking discussions with experts in the field, will review results of previous and ongoing clinical trials with gadolinium-containing contrast agents, and is working with the manufacturers to review all safety reports and adverse event reports. FDA will assess all available information to determine if product labeling changes or other actions are necessary for gadolinium-containing contrast agents.

12. What information was known about serious side effects prior to the approval of gadolinium-containing contrast agents?

The 5 U.S. approved gadolinium-containing contrast agents were approved between 1988 and 2004. In the combined pre-marketing studies for these approved gadolinium-containing contrast agents, over 3000 patients were studied.

The most common serious side effect from gadolinium-containing contrast agents is an allergic reaction that is usually mild but can occasionally be severe and even result in fatalities. Some patients develop skin conditions, such as rash, sweating, itching, hives, and facial swelling. Most of these conditions are considered allergic in nature. Gadolinium-containing contrast agents can be very irritating to the veins into which injected, with superficial inflammation or irritation of blood vessels and blood clots.

Very few patients with severely compromised kidney function or those on dialysis were studied in the pre-marketing studies. The labels for gadolinium-containing contrast agents caution that the risk of toxic reactions may be greater in patients with impaired kidney function because gadolinium is mostly excreted by the kidney.

13. What should patients do with this new information?

If you have severely impaired kidney function and you received a gadolinium contrast MRA, you should bring this to the attention of your treating physician. If you have advanced kidney failure and a physician has prescribed an MRI or MRA study with contrast, ask if there are alternative diagnostic contrast agents or tests that could be as effective.

14. What should healthcare providers do in response to this new information?

Physicians should be cautious regarding the use of gadolinium-containing contrast agents, especially at high doses, in patients with advanced renal failure. If such a patient receives gadolinium contrast MRA, prompt dialysis should be considered. Physicians should also report all cases of NSF/NSD to the FDA MedWatch at http://www.fda.gov/medwatch/.

15. What additional actions are likely to follow?

FDA will complete its ongoing analysis of these preliminary findings and then consider multiple options such as: modifying the product label or requiring additional studies. FDA may also consider risk management options.

16. Where can I find more information about gadolinium-containing agents and about NSF/NFD?

The package inserts provide more information about all of the approved gadolinium-containing agents. More information about NSF/NFD can be found at the following website: http://www.pathmax.com/dermweb/.

SOURCE: FDA

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