FDA Drug Safety Communication

FDA is requiring all drugs called Erythropoiesis-Stimulating Agents (ESAs) to be prescribed and used under a risk management program, known as a risk evaluation and mitigation strategy (REMS). The ESAs that are part of the REMS are marketed under the names Epogen, Procrit, and Aranesp. FDA required Amgen, the manufacturer of these products, to develop a risk management program because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.

As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. In addition to the Medication Guide, Amgen was required to develop the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology program for healthcare professionals who prescribe ESAs to patients with cancer.

The ESA APPRISE Oncology program requires that all healthcare professionals who prescribe ESAs for patients with cancer to complete a training module that covers the use of ESAs, sign the patient/healthcare professional acknowledgement form prior to the patient receiving an ESA, and re-enroll in the ESA APPRISE Oncology program every three years.

Healthcare professionals who prescribe ESAs for anemia not caused by cancer chemotherapy are required to provide a copy of the Medication Guide to each patient or their representative when an ESA is dispensed. Healthcare professionals who use ESAs only for non-cancer uses are not required to enroll in the ESA APPRISE Oncology program.

View the full FDA Drug Safety Communication on FDA.gov