FDA Black Box Warning on Gadolinium

May 24, 2007

Back in December we reported on the FDA cautioning practioners about the use of gadolinium (an mri contrast agent) in patients with chronic kidney disease.  The FDA is now requesting a black box warning  stating “that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal 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.” 

Prior 12/06 post discussing NSF

FDA Request

One Response to FDA Black Box Warning on Gadolinium

  1. Josh Schultz on October 1, 2007 at 12:27 am

    Question: Regarding Gadolinium agent black box warning & Liver Disease

    Does the contraindication also pertain to people with chronic liver diseases such as hepatitis C who are not undergoing liver transplantation (yet), i.e. that they too are increased risk to develop NSF ?

    I assume not but am interested to know more about, specifically, which chronic liver diseases are covered by this warning.

    Feel free to respond to: joschua17@gmail.com

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