The FDA has issued a drug safety requirement stating that all Erythropoiesis-Stimulating Agents (ESAs) are to be prescribed and used under a risk management program, called risk evaluation and mitigation strategy (REMS), in order to ensure and promote safe usage of these drugs.

ESAs are used to treat anemia in individuals with chronic kidney failure, undergoing chemotherapy, HIV patients using zidovudine (Retrovir) and to reduce the number of blood transfusions during and after particular major surgeries. The mechanism of action of ESAs is to stimulate red blood cell production by the bone marrow.

The ESAs that are included in the REMS program are Epogen (epoetin alfa), Procrit (epoetin alfa), and Aranesp (darbepoetin alpha).

Amgen, the manufacturer of ESAs, introduced REMS because studies showed an increase risk of tumor growth and shorter survival rates in cancer patients taking ESAs. In non-cancer patients taking ESAs for other conditions, such as HIV patients taking EDAs for anemia, studies found an increase in risk of a heart attack, heart failure, stroke or blood clots.

The main requirement for REMS is that all health professionals must provide patients with a Medication Guide that outlines all the risks and benefits of ESAs.

Additionally, ESA APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology program was developed as additional guidance for health professionals that provide treatment to cancer patients.

One main goal of REMS is to help physicians and patients in making informed decisions by providing information on the risks of ESAs. Another goal is to increase the survival rate and decrease the number of poor tumor outcomes through ESA APPRISE.

Currently, ESAs are not approved for the treatment of side effects of anemia, such as fatigue, in cancer, surgical or HIV patients taking zidovudine.

To ensure safe usage, the FDA and Amgen have changed the prescribing information for these drugs, which includes a new boxed warning, updated warning, and changes to the dosage and administration sections.

For more information, please see FDA’s press release and FDA’s transcribed podcast.