FDA: Prescribing Change for ESAs

ESAs are approved for to treat anemia due to chronic kidney disease, chemotherapy, and certain HIV treatments
ESAs are approved for to treat anemia due to chronic kidney disease, chemotherapy, and certain HIV treatments

Prescribers and hospitals no longer need to be certified to prescribe and/or dispense erythropoiesis-stimulating agents (ESAs) to patients with cancer as the Food and Drug Administration (FDA) has released the Risk Evaluation and Mitigation Strategy (REMS) requirement for these drugs.

ESAs (EpogenProcritAranesp) are approved for the treatment of anemia due to chronic kidney disease, chemotherapy, certain HIV treatments, and also to reduce the number of blood transfusions during and after certain major surgeries. The FDA has determined that the ESA REMS, which was limited to the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy, is no longer necessary to ensure that the benefits of these agents outweigh the risks of shortened overall survival and/or increased risk of tumor progression or recurrence in patients with cancer.  

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The decision was made based on data which showed that clinicians demonstrated acceptable knowledge of the product risks and the need for counseling of patients about these risks. Drug utilization data also showed appropriate prescribing of ESAs consistent with the intended use as a treatment alternative to red blood cell transfusion for anemia associated with myelosuppressive chemotherapy.

The labeling for ESAs continues to include information on the increased risk of tumor progression or recurrence, death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access, so while the REMS may no longer be required, clinicians should keep these risks in mind when prescribing. Clinicians are encouraged to discuss the risks and benefits of using ESAs with each patient before initiating use.

For more information visit FDA.gov.