Boxed Warnings for Erythropoiesis-Stimulating Agents Expanded Again

The black-box warnings for erythropoiesis-stimulating agents have been updated with information on the increased risk for death and tumor progression in patients with early breast cancer and cervical cancer.

The warnings note that Aranesp (darbepoetin alfa) and Epogen and Procrit (epoetin alfa) pose higher risks when dosed to achieve hemoglobin levels of 12 g/dL or higher, and risks at lower hemoglobin targets have not been excluded. Accordingly, physicians are advised to "use the lowest dose needed to avoid red blood cell transfusions."

Previous warnings have highlighted the risks for patients with non–small-cell lung, head and neck, and lymphoid cancers.

The FDA's Oncologic Drugs Advisory Committee is scheduled to review the safety of this drug class on Thursday.