EU to consider greater warnings for anemia drugs

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) proposal includes amending the summaries of product characteristics (SmPCs) for all approved ESAs to stipulate a uniform target hemoglobin range for all epoetins of 10 g/dL to 12 g/dL with guidance to avoid sustained hemoglobin levels above 12 g/dL and providing guidance for dosage adjustments to maintain hemoglobin concentration between 10-12 g/dL.

The special warnings would be amended to explain that trials have shown an unexplained excess mortality in association with high target hemoglobin concentrations (greater than 12 g/dL), and that epoetins have not been shown to improve overall survival or the risk of tumor progression in patients with anemia associated with cancer.

The proposed amendments are not final and Amgen will continue discussions with EMEA to finalize the language and update product labeling accordingly. Over the coming weeks Amgen will also advise prescribing health care professionals of the appropriate changes in the form of a dear health care professional (DHCP) letter. Final approved prescribing information is expected in early 2008.