Scrambling to fix rituximab's label

The European Medicines Evaluation Agency beefed up package insert labeling for Idec Pharmaceuticals Inc.'s Mabthera rituximab following eight fatalities associated with the drug worldwide. The action comes following a change in the package insert for the drug in the U.S. in September, based on off-label treatments of two patients with prolymphocytic leukemia in the U.S., that warned of increased risk of infusion-related events among patients with high numbers of tumor cells circulating in their bloodstreams.

EMEA's action now has prompted both of IDPH's marketing partners - F. Hoffmann-La Roche in Europe and Genentech Inc. in the U.S. - to send "Dear Doctor" letters that will have an unknown effect on sales of rituximab...