Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging: FDA Requests That A Boxed Warning and New Warnings Be Added To Prescribing Information
May 24, 2007 06:39

Date: Wed, 23 May 2007 11:18:46 -0400 From: CDER MEDWATCH LISTSERV Subject: FDA - MedWatch - Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging: FDA Requests That A Boxed Warning and New Warnings Be Added To Prescribing Information MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of the Agency's request for the addition of a boxed warning and new warnings about the risk of nephrogenic systemic fibrosis (NSF) to the full prescribing information for all gadolinium-based contrast agents (GBCAs). The new prescribing information FDA is requesting highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73 square meters) and patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. Healthcare professionals should avoid the use of a GBCA in these patients unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging. Read the complete 2007 Safety Summary, including a link to the FDA Healthcare Professional Sheet, FDA News Release, and Q & A Document regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Gadolinium _________________________________________________________