FDA Panel Supports New Warnings for Omniscan, Optimark
A Food & Drug Administration (FDA) advisory panel has supported new warnings for General Electric’s Omniscan and Covidien Inc.’s OptiMark that say they should not be used in patients with severe kidney disease. The panel felt that Omniscan and OptiMark, along with Bayer’s Magnevist, appeared to carry a higher NSF risk than similar products.
The same FDA panel also recommended restricting the use of Magnevist to patients without kidney severe kidney disease. However, there was less consensus on the panel in regards to Magnevist.
The recommendations represented a “preponderance of opinion” on the panel, and not a formal vote.
As we previously reported, Covidien has already decided to modify the label of OptiMark to contraindicate its use in patients with severe kidney impairment because of its association with NSF.
According to documents released last month by the FDA in advance of yesterday’s meeting, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMark. The lowest risk was associated with Prohance and Multihance, both marketed by Bracco Diagnotics. However, the FDA was unable to rule out a risk for any of the agents.
