Restrict Omniscan, OptiMark, FDA Panel Says

A panel convened by the Food & Drug Administration (FDA) has found that Omniscan, OptiMark and Magnevist appear to carry the greatest risk of nephrogenic systemic fibrosis. The group of outside experts recommended that the labeling for OptiMark and Omniscan be updated to restrict their use to patients without severe kidney disease. The panel did not reach consensus on Magnevist, though some members did advocate for a similar warning.

The panel’s findings are no surprise to the NSF lawyers at our firm. More than 500 lawsuits over NSF, a debilitating and often fatal disease that appears only in people with severe kidney disease who have been exposed to gadolinium, have been filed in U.S. courts against makers of these drugs. The majority of these lawsuits involve Omniscan.

Omniscan has also been the gadolinium contrast dye most cited in NSF reports filed with the FDA and European regulators. In November 2009, Europe’s health regulatory agency said Omniscan, Magnevist and Optimark shouldn’t be used in patients with severe kidney problems.

The FDA advisory panel was convened to comment on the agency’s latest risk assessment of gadolinium agents, and on filings submitted by the manufacturers. That assessment found that Omniscan, Optimark and Magnevist appeared to carry the highest risk of NSF. The lowest risk was associated with Bracco Diagnotics’ Prohance and Multihance, though the danger could not be ruled out for any of the agents.

The FDA staffers who conducted the assessment also recommended that the drug labels note the varying levels of risks with each product. They did not recommend removing any gadolinium agent from the market.

The release of that risk assessment in November 2009 did prompt one company, Covidien, to add a new warning to its OptiMark product. At the time, a spokesperson for the company told Reuters that ?it was prudent to act now, rather than wait for a causal link? to be established? between the imaging drugs and NSF.

All gadolinium contrast dyes already bear a black box warning – the FDA’s strongest safety warning – about the risk of NSF. That black box was mandated in September 2007. But according to Reuters, at the advisory panel meeting, most members felt prescribing instructions for Omniscan and Optimark should clearly warn they should not be used in severe kidney disease patients.

Dr. Sidney Wolfe, a panel member and head of Public Citizen?s Health Research Group, was among those pushing for stronger warnings on Omniscan and Optimark. According to Reuters, Dr. Wolfe expressed concerns that leaving the same warning on all the drugs ?may cause more problems than if you distinguish between the drugs as best as you can.”

Other members expressed concerns that labeling for gadolinium agents needed to reflect their real world use. Radiologists speaking at the meeting noted that gadolinium contrast dyes are, for the most part, no longer used in people with severe kidney disease.

No actual vote was taken at the advisory panel meeting, but the recommendation represented the overall opinion of the panel. The FDA will now determine what, if any, label modifications Omniscan, Optimark and the other agents will undergo. The FDA does not have to follow recommendations of advisory panels, but it usually does so.