The FDA has approved a risk management program to inform health care providers and their patients about the risks of erythropoiesis-stimulating agents (ESAs), which include epoetin alfa and darbepoetin alfa.

In April 2008, FDA required Amgen, which makes the drugs, to establish this risk management program based on studies showing that ESAs caused tumors to grow faster and resulted in earlier deaths in some cancer patients, according to an FDA statement.

A part of the program called APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) “requires specific training and certification of health care professionals who administer chemotherapy to patients with cancer and counseling of their patients,” the FDA noted. APPRISE does not apply to patients treated with ESAs for anemia due to other circumstances.

Continue Reading