Quoted from http://www.businessweek.com/bwdaily/dnflash/content/dec2009/db2009122_957825.htm
The FDA May Tighten Rules on Omniscan, a GE MRI Drug
An FDA review says MRI imaging drugs that contain gadolinium may be even riskier for kidney patients than it previously believed
By Jeff Gerth
Editor's Note: Gerth is a reporter with ProPublica, a nonprofit journalism organization in New York.
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, highlighted in an October story by BusinessWeek and ProPublica, 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.
An FDA advisory panel is scheduled to assess on Dec. 8 whether new restrictions or warnings are in order for the three drugs. The others are Bayer HealthCare's Magnevist, the market leader, and Optimark, made by Mallinckrodt.
All three have been associated with nephrogenic systemic fibrosis, or NSF, which can occur in patients with impaired kidney function. The drugs, which contain the metal gadolinium, are injected during magnetic resonance scans. Although the cause of NSF is uncertain, researchers theorize that an inability to eliminate gadolinium may be a factor. About 8 million vials of gadolinium-based imaging agents are sold each year. So far, the number of NSF cases numbers in the hundreds.