Gadolinium-containing MRI contrast agents: nephrogenic systemic fibrosis

01 February 2007

Magnetic resonance imaging (MRI) is a machine used in a hospital to produce images of the internal structure of the body. Patients undergoing MRI are sometimes given drugs called contrast agents which help to enhance the MRI image. 

Contrast agents that contain a metal called gadolinium may contribute to a rare but serious, and sometimes fatal, disorder called nephrogenic systemic fibrosis (NSF) in people with kidney disease. NSF is characterised by swollen and thickened skin, and is a scarring condition that can lead to organ failure and death. 

This Public Assessment Report published in 2007 summarises the evidence for NSF associated with gadolinium-containing agents. An article on this safety issue was also published in the August 2007 issue of Drug Safety Update (page 2)PDF file (opens in new window) (124Kb) (our monthly publication for health professionals on the safety of medicines and vaccines).

 

January 2010 - updated information: 

In 2009, the issue of NSF in association with gadolinium-containing contrast agents was reviewed in Europe.

The review showed that the highest NSF risk is associated with Omniscan (gadodiamide), OptiMARK (gadoversetamide) and Magnevist (gadopentetic acid). These agents should not be used in patients with severe kidney disease, patients who are waiting for a liver transplant or who have recently received a liver transplant, or in new-born babies.

See also:

Article in January 2010 issue of Drug Safety Update

Press release from the European Medicines Agency on NSF with gadolinium-containing contrast agents (November 2009)

This report presents the evidence that was available when the regulatory decision was made, showing a ‘snapshot’ of the clinical landscape at the time. However, any advice in this report remains current unless it is superseded by a more recent report (where relevant, this is indicated).

Page last modified: 11 February 2016