WARNINGS REQUIRED ON USED GADOLINIUM

Saya membaca sebuah kiriman email dari : U.S Food & Drug Administration (FDA) fda@service.govdelivery.com

kepada : abusuquf@yahoo.co.id tanggal kamis;9 Sept 2010 23.00.27

The U.S Food & Drug Administration is requring that gadolinium-based contrast agent (GBCAs) carry new warnings on their labels about the risk of a rere and potentially  fatal condition known as nephrogenic system fibrosis (NSF) ih the drug is administered to certain patients with kidney disease.

Three of the GBCAs – Magnevist, Omniscan, and Optimark-will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease.All GBCAs labels will emphasize the need to screen patients to detect these type of kidney dysfunction before administration.

GBCAs are intervenous drugs approved by the FDA for use with magnetic resonance imaging or magnetic resonance angiography to help detect abnormalities of body organs, blood vessel and other tissue.

NSF is a conditional involving the formation of excess fibrous connective tissue in the skin, joints, eyes and internal organs.Symtoms of NSF can include scalin, hardening, and tightening of the skin, red, or dark patches on the skin, and stiffness.NSF may lead to death, especially if it involves body organs.

For more information please visit : GBCAs