Fda Warns Of Increased Risk Of Nephrogenic Systemic Fibrosis Associated With Certain Mri Dyes

Fda Warns Of Increased Risk Of Nephrogenic Systemic Fibrosis Associated With Certain Mri Dyes

By:


Nephrogenic Systemic Fibrosis is a potentially fatal disease that is caused by certain contrast dyes used in medical exams such as Angioplasties, CT Scans, MRI and MRA, and Venograms. One interesting study is called, Nephrogenic Systemic Fibrosis by Breitschaft A, Stahlmann R. - Institut fr Klinische Pharmakologie und Toxikologie, Charit Campus Benjamin Franklin, Garystr. 5, 14195 Berlin. Here is an excerpt:

The approval of gadofosveset trisodium as the first imaging agent for magnetic resonance angiography (MRA) by the US Food and Drug administration (FDA) in December 2008 served as a motive to review a rare serious adverse reaction possibly related to the use of gadolinium based contrast agents. Nephrogenic systemic fibrosis (NSF) is a disabling and potentially fatal disease characterized by thickening and hardening of the skin, especially of the extremities. It is restricted to patients with renal insufficiency (estimated glomerular filtration rate [eGFR] < 30ml/min/ 1,73 m2). Systemic manifestations may involve skeletal muscles, lungs and myocardium. Progressive fibrosis may restrict the movement of joints, leading to contractures limiting mobility of the patients.

The chemical structures of the chelates account for different stabilities of the GBC agents. Most cases of NSF were reported after exposure to gadodiamide or gadopentetate dimeglumine, which represent linear, non-ionic imaging agents. In contrast, macrocyclic, ionic imaging agents have rarely been associated with this disease. Although the recently FDA approved gadofosveset trisodium has a linear structure and a long plasma half life due to high protein binding, there have been no reports of NSF up to date. This may be due to the much lower doses required for this agent compared to gadodiamide (approx. 0,03 mmol/l compared to 0,2 mmol/). Since there is no effective therapy for NSF, the top priority is to avoid exposure to gadolinium based contrast agents in patients at increased risk. In case of renal insufficiency (eGFR < 30 ml/min/1,73 m2) they should only be given if clearly necessary. After a thorough risk-benefit-assessment, the lowest possible dose should be used.

Another interesting study is called, Nephrogenic Fibrosing Dermopathy Nephrogenic Systemic Fibrosis: Report of a New Case With Literature Review by S. Daram, C. Cortese, B. Bastani - American Journal of Kidney Diseases, Volume 46, Issue 4, Pages 754-759. Below is an excerpt: Abstract - Nephrogenic fibrosing dermopathy (NFD) is a fibrosing condition of the skin that is being described increasingly in patients with renal diseases, many of whom are on dialysis therapy or have undergone renal transplantation. Its etiopathology is unknown, and no standard therapy currently exists. We describe a patient with NFD for whom histopathologic studies indicated that the fibrotic process affected subcutaneous tissue, striated muscles, diaphragm, pleura, pericardium, great vessels of the heart, left ventricle and septum, and tunica albuginea in addition to the dermis. Fibroblast-like cells positive for CD34 and CD45RO and scattered CD68-positive cells were found in affected tissues. The presentation of our case is unusual in that the disease process started in the lower abdomen and upper extremities and involved the upper extremities to a greater extent than the lower extremities. Our findings indicate that the fibrosis associated with NFD can extend beyond dermis and, as part of a systemic fibrosing disorder, can involve subcutaneous tissues, striated muscles, diaphragm, pleura, pericardium, and myocardium. We therefore suggest that nephrogenic systemic fibrosis would be a more appropriate term for this disease entity.

If you found either of these excerpts interesting, please read the studies in their entirety.

About the Author:
Monty Wrobleski is the author of this article. For more information please click on the following links



Mesothelioma Lawsuit Settlements,

Nephrogenic Systemic Fibrosis Lawsuit,

BP Oil Spill Class Action Lawsuit



Article Originally Published On: http://www.articlesnatch.com


Tags: , , ,

|

Loading...
Related....
Videos...

Recent Chronic-Illness Articles

Comments

Still can't find what you are looking for? Search for it!

Loading

Site Navigation:

Copyright 2005-2011 ArticleSnatch, LLC - All Rights Reserved.
Privacy Policy | Terms of Service.