EMA suspends sale of GE's MRI Contrast, GE asks agency to reconsider
General Electric Co's healthcare business said it had requested the European Medicines Agency to reconsider the recommendation made by its panel to suspend the marketing authorization of certain agents used in MRI scanning.
The recommendation by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) last week came after a small amount of chemical deposit was found in the brains of patients. No harm linked to gadolinium in the brain has been reported.
The panel recommended the ban of GE Healthcare's MRI contrast agent called omniscan, which is sold globally.
The committee suggested the EMA to stop the marketing of four linear gadolinium contrast agents (GdCAs), which are chemical substances injected into the body to improve the quality of the MRI images.
GE Healthcare said it would employ all available measures and continue its research program to understand any potential risks from brain gadolinium.
"GE Healthcare remains firm in our evidence-based belief that the overall benefit-risk profile of linear agents including Omniscan is positive," the company said on Thursday.