Gadolinium NSF Lawsuit & News Blog

Gadolinium MRI Contrast Dye

Thu, 17 Jan 2008 16:54:55 -0500

Nephrogenic Systemic Fibrosis, or NSF, is also known as Nephrogenic Fibrosing Dermopathy, or NFD, is a rare and serious disease that affects only patients with pre-existing kidney problems. NSF involves fibrosis of skin, joints, eyes, and internal organs where scar tissue forms that is so thick the skin and joints become immobile and this appears to be associated with Gadolinium exposure and people with severe kidney failure. Patients with NSF will develop large areas of hardened skin due to fibrotic nodules and plaques and shows a proliferation to the dermal fibroblasts and dendritic cells, increased elastic fibers, thickened collagen bundles, and deposits of mucin, and in some more serious cases, NSF can paralyze the internal organs ending with fatal results.

The first case of NSF appeared in patients around 1997, displaying symptoms such as high blood pressure, burning and itching, and swelling or hardening of the skin, but was labeled as an independent disease. Some other symptoms that also appear in patients with NSF include red or dark patches on the skin, muscle weakness, and pain that can be felt deep in the hip bones or ribs. NSF may even progress to the point of severe stiffness of the joints and can even be so serious and dangerous to lead to death.

NSF was discovered in 2006 as having a direct link relating the use of Gadolinium Magnetic Resonance Imaging (MRI) contrast dyes in patients with kidney problems. As a result of multiple studies showing this same association, later in 2006, the Food and Drug Administration issued a notification addressed to health care providers and the general public stating that patients with moderate to end-stage kidney disease that may receive a MRI or MRA where the Gadolinium based contrast dye may develop Nephrogenic Systemic Fibrosis, or NSF. Then in 2007, the FDA decided that manufactures of Gadolinium contrast dyes to place a black box warning, which is also the strictest type of FDA warning, on the product labels to advise people with kidney problems of the risk of NSF.

Currently, there is not any cure for NSF, and the specific cause is still not completely understood. Yet, the evidence of the role that Gadolinium MRI contrast may play in the development of NSF is steadily becoming irrefutable. Researchers at Yale University have reported that 95 percent of those with NSF had an MRI that involved a Gadolinium MRI contrast dye two to three months before the symptoms appeared. Another study done by researchers at Massachusetts General Hospital has also found that kidney patients who had undergone MRIs with Gadolinium MRI contrast dyes were ten times more likely to develop NSF than patients who had not been exposed to such agents.

What this means for patients with NSF is that life can become very unbearable as the skin becomes so hardened, the joints become so stiff that movement becomes impossible, and the disease may even start affecting the heart, lungs and liver. NSF can even lead to death as there are not any effectively known treatments; however, some patients have shown improvement after receiving a kidney transplant.

As it is, the FDA is urging all patients that may believe they suffer from NSF to immediately contact their doctor. Should a patient with kidney disease need to have an MRI or MRA done, the FDA is also encouraging those patients to seek other imaging methods that do not use the Gadolinium based contrast whenever possible as there is currently no alternative for Gadolinium based MRI contrast agents.

If a patient has found that they have developed NSF after receiving a MRI or MRA, then please click here to have a free case evaluation done.

FDA-MedWatch -Gadolinum Based Contrast Agents: Dear Healthcare Professional Letter Issued Regarding Boxed Warning And Revisions to Warning Section Of Prescribing Information

Mon, 1 Oct 2007 10:19:58 -0500

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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).

Read the complete MedWatch 2007 Safety Summary including a link to the Dear Healthcare Professional letter and the revised labeling at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Gadolinium

MRI Dye Has Serious Consequences

Thu, 2 Aug 2007 11:23:22 -0500

"Do You have a case against Tyco?"

A lawsuit has been filed in the United States District Court, Middle District of Tennessee, Nashville Division on behalf of clients against Tyco International, Ltd. (NYSE: TYC), because of serious injuries caused by dye injection used in magnetic resonance imaging (MRI) scans.

In 2004, the plaintiff, a kidney failure patient, underwent an enhanced MRI, which included injecting the drug OptiMARK, a gadolinium-based dye, used as a contrast agent. One week after the MRI, he began showing signs of Nephrogenic Systemic Fibrosis (NSF). His symptoms included thickened skin around both elbows and both knees, pain in both legs, knees, and elbows along with trouble walking.

The FDA has recalled gadolinium dyes stating: Patients with moderate to end-stage kidney disease who receive an MRI with a gadolinium-based contrast agent may get NSF, which is debilitating and may cause death.

The suit charges the defendants as knowing that the dye could cause NSF in kidney patients, but continued to distribute it. They also failed to warn physicians of the risks of kidney patients potentially developing NSF.

It was very risky for him to receive the dye injection before the MRI. The attorney will try to prove that the defendants have known for years that kidney disease patients who receive the injection of gadolinium-based dye were at very high risks for developing NSF, which is a horrible medical condition. Unfortunately, the defendants chose to conceal the risk of the procedure.

http://www.prweb.com/releases/2007/7/prweb543100.htm

Two Rare Skin Hardening Conditions: Scleroderma and NSF - Have You Been Properly Diagnosed?

Wed, 1 Aug 2007 10:53:28 -0500

Scleroderma is a rare but debilitating autoimmune disease where the skin thickens and tightens, where the body's joints allow for less and less bending. Hands, elbows, and knees all become stiff. Hardening may also affect internal organs - heart, lungs, and kidneys, plus gastrointestinal tract and vascular system.

Another rare skin hardening condition is NSF or nephrogenic systemic fibrosis caused when people with kidney disease or on kidney dialysis receive a gadolinium contrast imaging injection with their MRI. People who receive MRIs but who do not suffer from kidney disease don't get NSF. NSF may also affect internal organs. Pneumonia is the number one cause of death for people with NSF.

It is unknown what causes scleroderma. Researchers believe scleroderma may be caused by a genetic predisposition interacting with environmental stimulus.

According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the immune system is believed to stimulate cells called fibroblasts, causing them to produce too much collagen. As the collagen builds, thick connective tissue within the skin and internal organs can interfere with their function.

Do You Have an NSF Lawsuit?

Localized scleroderma can take the form of reddish patches of skin that thicken into oval-shaped areas. As the disease progresses, the skin grows thicker even to the point of changing a person's appearance. The thickening can also spread, becoming systemic. The fingers, hands, face, lower arms, and legs are the only places affected if the spread is limited, but people also can suffer a range of symptoms including:

The formation of calcium deposits in the connective tissues, usually found on the fingers, hands, face, and trunk, and on the skin above the elbows and knees.
The small blood vessels of the hands or feet contract in response to cold or anxiety; a patient may suffer gangrene.
Swallowing difficulty or chronic heartburn happens when the esophagus loses normal movement.
Difficulty bending fingers caused by excessive collagen deposits
Small red spots appear on the hands and face caused by swelling of tiny blood vessels.

There is no effective treatment for NSF.

Upright MRI System Sales Soar

Tue, 31 Jul 2007 12:11:48 -0500

FONAR Corporation reported that physicians who use the FONAR UPRIGHT™ MRI are testifying to the unique benefits of the technology in patient care. The testimonials of the prominent surgeons and leading radiologists are also appearing in advertisements in numerous other major medical magazines, including the Journal of the American Medical Association, Spine, Radiology, Diagnostic Imaging, the Journal of the American Academy of Orthopedics and Journal of Neurology.

Their testimonials on the medical benefits have resulted in the recent stream of seven new orders for these upright MRI scanners.

All the surgeons featured own FONAR UPRIGHT™ Multi-Position™ MRI, so they have hands-on experience with its unique ability to image pathology in the position of the patient's symptoms. Their consensus is that it improves surgical outcomes in over 20 percent of cases.

This new tool provides the necessary technology to image the patient's spine pathology in a full range of motion. As a result, it gives surgeons the right tool to overcome the present diagnostic limitations.

http://www.fonar.com/news/071207.htm

MRI recommended for breast cancer screening

Tue, 31 Jul 2007 12:10:20 -0500

The American Cancer Society is now recommending a yearly MRI for women at high risk.

For the MRI, a woman would lie on her stomach, her breasts through an opening in the table. She's injected with contrast dye. Masses will take up the dye, drawing attention to possible cancers a mammogram may miss. Mammography uses x-ray radiation, while MRI uses a magnetic field to get images.

Once used only after a mammogram had spotted something suspicious, the American Cancer Society is now recommending some women get an annual MRI for cancer screening. It's for those women at highest risk. That means either they or a sibling has a certain genetic trait; they've had breast cancer before; or they've received radiation treatment to the chest between ages ten and 30 for a disease such as Hodgkin.

But MRI screening isn't for everyone. MRIs are very expensive - about $1,000 which is ten times the cost of mammography. It's also very time consuming. The MRI exam takes at least 45 minutes to complete that means you can do only ten to 12 MRI patients a day versus 60 to 70 mammograms.

While the MRI is sensitive, it's not very specific, meaning more false positives. Also a MRI doesn't see everything a mammogram can. A mammogram can see calcifications which is also a sign of cancer and that may not be associated with a mass and can't be seen on MRI.

MRI does not replace a mammogram rather it's an extra imaging that works together with it.

Even with the drawbacks, for women at highest risk, adding an MRI is worth it. He says the patient will benefit from the peace of mind she gets from the MRI. (Yes, but will her health insurance pay for it?)

http://www.wibw.com/home/headlines/8464252.html

MRI: Advantages and Disadvantages

Tue, 31 Jul 2007 11:13:01 -0500

MRI stands for magnetic resonance imaging and for now it's the medical profession's best tool to see what's inside your body. Let's say it beats cutting you open to look inside.

Some advantages of MRI include diagnosing strokes in their earliest stages; diagnosing MS (multiple sclerosis); diagnosing brain and pituitary tumors; diagnosing brain, spine, or joint infections; visualizing torn ligaments in the wrist, knee, and ankle (sports player use MRIs); visualizing shoulder injuries; diagnosing tendonitis; evaluating soft tissue masses; and evaluating bone tumors, cysts, and herniated discs in the spine.

MRI systems do not use ionizing radiation as MRI contrast materials have a very low incidence of side effects. Another advantage of a MRI is its ability to image in any plane. CT scans are limited to one plane, the axial plane. An MRI system can create axial images.

Like anything MRI also has disadvantages: People with pacemakers cannot have MRIs. Also some people who are morbidly obese cannot fit in into an MRI system. Claustrophobic patients cannot usually make it through a MRI. The machine makes a tremendous amount of noise during a scan. The noise sounds like a continual, rapid hammering. Patients are given earplugs or stereo headphones to muffle the noise (in most MRI centers you can even bring your own cassette or CD to listen to). The noise is due to the rising electrical current in the wires of the gradient magnets being opposed by the main magnetic field. The stronger the main field, the louder the gradient noise.

MRI scans require patients to hold still for extended periods of time. MRI exams can range in length from 20 minutes to 90 minutes or more. Even very slight movement of the part being scanned can cause distorted images which means the scanning will need to be repeated. Orthopedic hardware (screws, plates, artificial joints) in the area of a scan can cause severe distortions on the images. MRI systems are very expensive; therefore the exams are also very expensive. Will your health insurance pay for that?

Lastly, people with kidney disease or on dialysis or people who didn't know they had kidney disease are likely to develop an incurable condition called Nephrogenic Systemic Fibrosis (NSF) from the MRI dye injection gadolinium. NSF causes a hardening or stiffening of the skin and joints. If this has happened to you, consider contacting a lawyer familair with NSF Gadolinium Lawsuits.

MRI advantages far outweigh the disadvantages - that is of course, if you don't have kidney disease.

(Source: HowStuffWorks.com)

Mysterious Disease: Scleroderma

Tue, 31 Jul 2007 10:20:23 -0500

Skin should be soft and supple. What happens toskin when it thickens and tightens and becomes deformed and unyielding? Then the joints are affected by less flexibility and bending. Hands, elbows, and knees become stiff.

Scleroderma is believed to be an autoimmune disease, in which the immune system turns against one's own body. It's not known what prompts the immune system attack, although researchers believe scleroderma is probably caused by a genetic predisposition interacting with environmental stimulus.

Worst case scenario, hardening reaches into the internal organs with what could be life-threatening results. Kidneys, lungs, heart, gastrointestinal tract, and vascular system can become compromised as the organs grow rigid. According to the American College of Rheumatology, an estimated 200 to 300 people per million in the United States suffer from scleroderma. Some 12 to 20 new cases per million are diagnosed annually.

Localized scleroderma can take the form of reddish patches of skin that thicken into oval-shaped areas. The center of each patch becomes ivory colored with violet borders. The patches appear most often on the chest, stomach, and back but also can appear on the face, arms, and legs.

In the most serious cases, internal organs are affected. Kidneys quit working. Lungs stiffen, making it hard to take a breath. Hearts are unable to pump as efficiently. Doctors treat scleroderma by treating the complications it causes. One of the success stories in scleroderma treatment involves new autoimmune drugs that preserve kidney function. People with scleroderma used to die mainly from kidney disease, but these days they are more likely to die of lung problems.

Nephrogenic systemic fibrosis (NSF) is also a condition caused by hardening of the skin and joints. Have you been misdiagnosed with scleroderma when you really had NSF? Have you been treated with scleroderma drugs that could further fuel your NSF diagnosis and treatment? Do you have a medical malpractice case? Do you need a Pennsylvania lawyer?

http://news.yahoo.com/s/hsn/20070727/hl_hsn/sclerodermaararebutdevastatingdisease

Outlook for Scleroderma Survival Increases

Wed, 25 Jul 2007 10:40:38 -0500

People who suffer from scleroderma (systemic sclerosis) are living significantly longer, compared with 30 years ago. Scleroderma, a rare autoimmune disorder of unknown origin, results when collagen builds up in the body's connective tissue and causes thickening of the skin. Progressively, scleroderma causes stiff joints and hardening of the internal organs and blood vessels.

Physicians who treat this rare disease of connective tissue hope the newer drugs now on the market may extend lives longer.

In the July 2007 issue of the journal Annals of the Rheumatic Diseases, a Georgetown professor studied 2,000 patients with scleroderma treated between 1972 and 2001 at the University of Pittsburgh and found that 10-year survival steadily improved over those years by 12 percent; from 54 percent to 66 percent.

The reason overall mortality has dropped is partly because a class of medications, angiotensin converting enzyme (ACE) inhibitors became available which dramatically improved the treatment of renal crisis. Renal crisis used to be almost always fatal and now it is a very treatable complication of scleroderma.

Now pulmonary arterial hypertension and pulmonary fibrosis, a condition that is traditionally the second-most frequent cause of death, is responsible for most of the mortality, but these conditions may be increasingly treatable.

While all scleroderma-related disorders are believed to affect as many as 900,000 people in the United States, only between 40,000 and 165,000 are diagnosed with systemic scleroderma. Like all scleroderma disorders, systemic scleroderma affects more women than men, and varies in severity.

The study found survival improved in each of the five-year periods, and that the frequency of death due to renal crisis significantly decreased over the 30 years, from 42 percent to 6 percent. But the proportion of patients who died from pulmonary fibrosis increased from 6 percent to 33 percent. The frequency of pulmonary hypertension also increased, but there was no change in gastrointestinal and heart-related deaths.

Use of ACE inhibitors made all the difference in saving patients from renal failure. It's important that physicians use drugs now available to treat lung disorders and researchers continue to search for new therapies.

http://www.medicalnewstoday.com/articles/76670.php

FDA Requests Box Warnings for MRI Contrast Agents

Fri, 22 Jun 2007 12:33:21 -0500

May 2007-- 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 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.

Companies who make MRI imagine are: Bayer Schering Pharma, Berlin, Germany, manufactures Magnevist; GE Healthcare, Chalfont St. Giles, U.K., is the maker of Omniscan; OptiMARK is manufactured by Mallinckrodt, Inc., Hazelwood, Mo.; and ProHance and Multihance are made by Bracco Diagnostics Inc., Princeton, N.J.

Source: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01638.html