Medication Guides and More Required for Erythropoiesis-Stimulating Agents

FDA has announced that it 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), to ensure their safe use. 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. As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs.

ESAs are approved for the treatment of anemia resulting from chronic kidney failure, chemotherapy, and certain treatments for Human Immunodeficiency Virus (HIV). They have other indications as well. However, studies have shown that ESAs can increase the risk of tumor growth, can shorten survival in patients with cancer who use these products, and can increase the risk of heart attack, heart failure, stroke, or blood clots in patients who use these drugs for other conditions. FDA wants to be sure that all patients are aware of these risks.

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. FDA reports that under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program.

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