ESAs come under scrutiny

March 19, 2007

The FDA has issued a public health advisory about revised product labeling for erythropoiesis-stimulating agents (ESAs), including darbepoetin (Aranesp, Amgen) and epoetin alfa (Epogen, Amgen; Procrit, Ortho Biotech).

The FDA has issued a public health advisory about revised product labeling for erythropoiesis-stimulating agents (ESAs), including darbepoetin (Aranesp, Amgen) and epoetin alfa (Epogen, Amgen; Procrit, Ortho Biotech). The updated information notes that patients should be informed of the increased risks of mortality, serious cardiovascular events, thromboembolic events, and tumor progression when used in off-label dose regimens or populations. A new boxed warning alerts prescribers that when hemoglobin levels are targeted greater than 12 gm/dl, an increased risk for death and serious cardiovascular events occurs. Also, beyond this level, there is shortened time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy and shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy. The revision in labeling also states that an increased risk of death exists at target levels of 12 gm/dl for cancer patients who are not receiving chemotherapy or radiation. Therefore, use of ESAs is not recommended in this population. The lowest dose of ESAs should be initiated that will gradually increase the hemoglobin to the lowest level sufficient to avoid the need for red blood cell transfusions, but not to exceed 12 gm/dl. The FDA is planning to further review the safety and efficacy of ESAs on May 10 at a meeting of the Oncologic Drugs Advisory Committee.

 

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