GE Healthcare (NYSE:GE) said yesterday it is looking to get its magnetic resonance imaging scanning contrast agent, Omniscan, re-cleared for use in Europe after a regulatory body recommended the suspension of it, and other certain MRI imaging agents.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee last week recommended suspending marketing of Omniscan, as well as other certain agents, upon receiving reports of traces of chemical deposits found in the brains of patients injected with the product.
The panel recommended a ban on GE Healthcare’s Omniscan, and suggested the EMA stop marketing of 4 linear gadolinium contrast agents.
GE Healthcare said it is invested in researching the product to understand any potential risks from brain gadolinium.
In 2010, the FDA banned the use of Omniscan and 2 similar imaging dyes in patients with severe kidney disease. The federal watchdog agency said that gadolinium-based contrast agents Omniscan, Magnevist and Optimark were associated with a greater risk of NSF and that enhanced screening to identify NSF risk was necessary, advising doctors to report cases of the syndrome.
Material from Reuters was used in this report.