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U.S. Department of Health and Human Services

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Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Magnevist, MultiHance, Omniscan, OptiMARK, ProHance

Audience: Radiologists, Nephrologists, Dermatologists, other healthcare professionals

[UPDATED 09/28/2007] Manufacturers of Gadolinium-based contrast agents issued a Dear Healthcare Professional letter to inform healthcare professionals of the addition of a BOXED WARNING and revisions to the WARNING section of the prescribing information for Gadolinium-based contrast agents as listed above used in Magnetic Resonance Imaging (MRI).

[Posted 05/23/2007] 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/1.73m2) 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.

[September 2007 - Letter - Bayer, GE-Healthcare, BRACCO, and MALLINCKRODT]
[May 2007 - Magnevist label - Bayer Healthcare Pharmaceuticals]
[May 2007 - MultiHance label - Bracco Diagnostics Inc.]
[September 2007 - Omniscan label - GE Healthcare]
[May 2007 - OptiMARK label - Mallinckrodt Inc.]
[May 2007 - ProHance label - Bracco Diagnostics, Inc.]

 

[May 23, 2007 - News Release - FDA]
[May 23, 2007 - Information for Healthcare Professionals - FDA]
[May 23, 2007 - Q&A - FDA]

 

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[June 08, 2006]