The U.S. Food and 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 -- highlighted in an October story by BusinessWeek and ProPublica -- marks a setback for GE Healthcare (GE), which contends its product is no riskier than competing imaging drugs. FDA reviewers said GE's drug, Omniscan, had a disproportionally high number of reports of the disease compared with its peers.
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