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Nephrogenic Systemic Fibrosis - cure needed!
  Nephrogenic Systemic Fibrosis, NSF, is a newly emerging disease caused by contrast agents (gadodiamide) used in magnetic resonance imaging, MRI.



NSF was first identified in 1997 by Dr Thomas Grobner in Austria and published in The Lancet in September 2000 (Cowper et al). It was termed Nephrogenic Fibrosing Dermopathy, NFD, at the time and renamed in 2005 to Nephrogenic Systemic Fibrosis, NSF.



The cause or causes were unknown. The cause was discovered in 2006 by Dr Henrik Thomsen, University Clinic Herlev, Copenhagen, Denmark. The contrast agent, a gadodiamide, released the toxic metal Gadolinium during MRI.



The only contrast agent used at Herlev was Omniscan made by GE Healthcare. There are other brands of gadodiamides, Dotarem, Magnevist, etc ... if these also release gadolinium is not known.



NSF symptoms:



Patients with NSF describe 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 or several weeks. The swelling inhibits the movement of joints, their flexion and extension, resulting in contractures.

Severely affected patients may be unable to walk and fully extend the joints of their arms, hands, legs and feet. Complaints of muscle weakness are common. The skin changes may start as reddened or darkened patches, papules or plaques. In time the skin may feel "woody" and the surface may resemble the texture of the peel of an orange.

Patients may experience burning, itching or sharp pain in areas of involvement.
Radiography may reveal calcifications of the soft tissue.
Deep bone pain has been described in the hips and rips.
The skin lesions are commonly symmetrical with zones between the ankles and thighs most commonly involved, followed by involvement between the wrists and upper arms.

Hand and foot swelling with blister like lesions has also been reported. Some patients have reported yellow papules or plaques around or near the eyes.

Rapid, new onset of fluctuating hypertension of unknown cause prior to the onset of skin lesions.

Is there a cure for NSF?

There is no consistently successful treatment for NSF. Improving renal function (due to any modality) seems to slow or arrest NSF, and in some cases allows for gradual reversal of the process over time.

As NSF is a rare, relative recent diagnosis, the natural history of the disease is not well understood. Complete spontaneous healing in a patient with ongoing kidney disease has not been reported yet. Several patients with NSF have died as a result of complications with their kidney disease or surgery.

How widespread is NSF?

Omniscan is in use since 1993, some fifty million MRIs using Omniscan were performed since and this number is growing daily. The procedure relies on kidney function and lymph function to flush the contrast agent out.

In February 07 the European Union banned Omniscan for use in patients with "reduced renal function". while the FDA issued a warning about all gadodiamides and recommended "use only if necessary" some weeks earlier.

Many GPs do not know about NSF. When they encounter the above symptoms they will hardly question the patient about MRI and what contrast agent was used. Hence most cases will go undetected and symptoms attributed to other conditions. There could be thousands of NSF cases out there, it could be millions. There are no official incident rates.

What can be done?

What I said about GPs also accounts for CAM therapists. While it may be difficult to get the message to GPs I am hopeful the word can be spread among CAM therapists.

It requires concerted actions to identify NSF patients - and develop a cure.

26. January 2010

Wilfrid Hartnagel
ceo, infoholix.net


Update 9.9.2010


The FDA said today that three agents -- Magnevist sold by Bayer Health Care, Omniscan by GE Healthcare and Optimark by Covidien of Ireland -- would be required to carry labels stating that they are "inappropriate for use among patients with acute kidney injury or chronic severe kidney disease." The labels will emphasize the importance of screening patients to detect kidney dysfunction before MRI contrast administration.



The FDA in 2007 required that gadolinium-based contrast agents carry black box warning labels indicating that patients who receive the products are at risk of developing NSF. The labeling applied to the five MRI contrast agents sold on the U.S. market at the time, which included the above three agents as well as the MultiHance and ProHance products sold by Bracco Diagnostics. In today's announcement, the FDA did not address whether it was changing the warning labels required of the Bracco products, nor of the other MRI contrast products approved since then, which include Eovist by Bayer and Ablavar by Lantheus Medical Imaging.



The FDA said that its review of the safety of the most widely used gadolinium-based contrast agents "determined that Magnevist, Omniscan, and Optimark are associated with a greater risk than other agents for NSF in certain patients with kidney disease."



In addition, data suggest that NSF may be caused by ANY gadolinium-based contrast agent. The agency continues to evaluate the safety of each MRI contrast agent to better estimate its NSF risks.



NOTE:



Claiming that only patients with acute kidney injury or chronic severe kidney disease are at risk constitutes a distortion of facts.


There is enough evidence to suggest that kidney diseases developed after MRI and arguably caused by gadolinium. The agency obviously avoids to establish this fact.


The agency also addresses fully blown NSF only. Partial symptoms rarely get attributed to NSF. These symptoms do not respond to treatment of any kind and the therapist wonders why as the association with gadolinium is not made.






India 1. Muljibhai Patel Urological Hospital in Nadiad, Gujarat, is the leading nephrology hospital in India having performed some 2000 kidney transplants, MPUH is aware of the issues caused by gadodiamides, MPUH calls for all hospitals in India and abroad to report incidences of NSF, adverse reactions and all other complications arising from gadodiamides, MPUH calls for patients who suffer from NSF and/or have symptoms after MRI to contact Sri Joseph Purathur, designated officer for MRI/gadodiamide issues at MPUH.

website e-mail
India 2. There are three hospitals in Mysore that offer MRI, all are aware of the dangers of gadodiamides and refuse to use them.

I, P S Narasimha Swamy of Mysore, have successfully treated patients with heavy metal poisoning such as lead and arsenic. I shall conduct a clinical trial in order to find a cure for NSF.

This clinical trial will be registered with the department of AYUSH (Ayurveda, Yoga and naturopathy, Unani, Sidhha, Homeopathy), the governmental institution that regulates these forms of medicine in India.

It will be funded by infoholix.net. Patients wishing to enroll please contact me or infoholix.net.

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