Anemia drugs require risk management

Erythropoiesis-stimulating agents (ESAs), sold under the brand names Epogen, Procrit, and Aranesp, now require a risk management program for their prescription and use, the FDA announced last week.

The program, known as a risk evaluation and mitigation strategy (REMS), has been instituted in response to studies showing that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer and increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions, according to an FDA press release.

As part of the REMS, a medication guide explaining the risks and benefits of ESAs must be provided to all patients taking the drugs. In addition, manufacturer Amgen was required to develop the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) program, which will provide specific training and certification for health care professionals who prescribe ESAs to patients with cancer.