The U.S. Food & Drug Administration is weighing further regulation of three drugs used to create high-contrast images on MRI scans, based on a new analysis that suggests they carry a higher risk of causing a rare, but potentially fatal disease.
The issue, marks a setback for GE Healthcare (GE), which contends that its product is no riskier than competing imaging drugs. FDA reviewers said GE’s drug, Omniscan, had a disproportionately high number of reports of the disease compared with its peers.