The European Medicines Agency’s Committee for Medicinal Products for Human Use has proposed that certain anemia drugs—including Amgen’s Epogen and Araresp and Johnson & Johnson’s Procrit—receive amended prescribing guidelines. The proposed restrictions are less severe than US restrictions: previous guidelines allowed for coverage of ESA treatments when patients’ hemoglobin levels fall between 11-14 g/dL; however the proposed new guidelines allow for coverage to begin when hemoglobin levels fall below 12 g/dL—or in the 10-12 g/dL range—which is more conservative than the 10g/dL that is required in the US. Also, the committee has proposed that a special warning be placed on the label explaining that “clinical trials have shown an unexplained increase in death when hemoglobin levels rise higher than 12 [g/dL].” Another proposed warning concerns the fact that the ESAs have not been proven to “improve the overall survival or risk of tumor progression in patients.”

The committee and drug manufacturers are still discussing the amendments and it is expected that final prescribing information will be available in early 2008.

Reuters: “Europeans to Tighten Guidelines on Anemia Drugs”

CNNMoney.com: “EU May Amend Aranesp Label”

Los Angeles Business Journal: “European Panel Mulling Drug Warnings”

Los Angeles Times: “EU May Warn on Drugs for Anemia”

Pharmaceutical Business Review: “EU to Consider Greater Warnings for Anemia Drugs”