GE Healthcare's priority is to provide safe products that help improve patient health. Recent publications indicate low levels of gadolinium are retained in the brain following repeated exposure to gadolinium-based contrast agents (GBCAs). We take very seriously any information concerning possible adverse events associated with our products. The FDA, Health Canada, American College of Radiology (ACR) and International Society for Magnetic Resonance in Medicine (ISMRM) have communicated that to date, there are no adverse clinical events causally associated with retention of trace amounts of gadolinium in the brain or other tissues in patients with normal renal function. These organizations have not recommended suspending the use of linear agents. We believe that the overall benefit-risk profile is positive for gadolinium-based contrast agents (including Omniscan) and these products should remain available as an option for radiologists. We are committed to working closely with the clinical community, academics and regulators to advance scientific understanding of the matter. Following the European Commission (EC) decision of 23.11.2017, we have appealed the EC decision and we will continue to make Omniscan available for use outside of the European Union.
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