Black Box Warning Ordered for Aranesp, Epogen, and Procrit - Part II
At a press briefing, Richard Pazdur, M.D., director of the Office of Oncology Drug Products at the FDA's Center for Drug Evaluation and Research, said that on the basis of data from several recently reported clinical trials, a black box warning had been added to the labels of the three drugs.
The warning states:
Avoid serious cardiovascular and arterial and venous thromboembolic events by using the lowest dose of Aranesp, Epogen, or Procrit that will gradually raise the hemoglobin concentration to the lowest level sufficient to avoid the need for blood transfusion.
Aranesp, Epogen, and Procrit and other erythropoiesis-stimulating agents increased the risk for death and for serious cardiovascular events when dosed to achieve a target a hemoglobin of greater than 12 g/dL.
Use of erythropoiesis-stimulating agents to achieve a target hemoglobin of 12 g/dL or greater in cancer patients shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy; shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy; and increased the risk of death in patients with active malignant disease not under treatment with chemotherapy or radiation therapy. Erythropoiesis-stimulating agents are not indicated for this patient population.
Patients treated before surgery with epoetin alfa to reduce allogenic red blood cell transfusions had a higher incidence of deep vein thrombosis. Aranesp is not approved for this indication.