OptiMARK Label Changes

In November 2009, the label of OptiMARK was modified to include a contraindication for people with severe kidney impairment. Educational materials for OptiMARK were also updated to help physicians make informed decisions regarding the appropriate use of the agent. The label modification followed news from the FDA that its review of gadolinium contrast dyes had revealed that OptiMARK, along with Omniscan and Magnevist, carried a higher risk of NSF than others.

Though the FDA’s drug safety unit said the NSF risk associated with the gadolinium contrast dyes ?does not compel removal of specific (imaging agents) from the U.S. market?, it recommended that the drug labels note the varying levels of risks with each product. While the lowest NSF risk was associated with Prohance and Multihance, the agency said ?the data do not appear to rule out an NSF risk for each of the agents.?