WASHINGTON (Reuters) - Imaging agents used with MRI scans appear linked to varying risks for a potentially fatal skin disease, U.S. Food and Drug Administration staff said in documents released on Tuesday.
The FDA said a staff review found the highest risk of the skin disease, nephrogenic systemic fibrosis, was associated with GE Healthcare’s Omniscan, Bayer AG’s Magnevist and Covidien’s Optimark.
The lowest risk was associated with Prohance and Multihance, made by Bracco Diagnostics, the agency said.
The agency said the staff review had limitations and it would take the issue to a panel of outside experts that meets in December.
Staff in the FDA’s drug safety unit said the magnitude of the risk “does not compel removal of specific (imaging agents) from the U.S. market” but recommended that the drug labels note the varying levels of risks with each product.
Reporting by Lisa Richwine, editing by Gunna Dickson