A Change in REMS Requirements

The US Food and Drug Administration (FDA) has lifted the Risk Evaluation and Mitigation Strategy (REMS) requirements for certain medications used to treat anemia.

These medications include epoetin alfa (marketed as Procrit, Epogen) and darbepoetin alfa (Aranesp), which belong to a class of medications called Erythropoiesis-Stimulating Agents (ESAs).

Epoetin alfa and darbepoetin alfa are approved to treat anemia (low red blood cells) caused by certain conditions, such as chemotherapy, chronic kidney disease and certain medications used to treat HIV.

The FDA is now saying the REMS is no longer needed because the benefits of these medications outweigh their risks. This update is for epoetin alfa and darbepoetin alfa specifically when they are being used to treat anemia that is tied to chemotherapy. In that context, the potential benefits outweigh the risks of reduced overall survival and/or increased risk of progression of tumors or cancer recurrence, according to the FDA. 

However, the fact that the REMS is no longer needed doesn't mean that these medications don't carry potentially serious risks.

The FDA will still require a REMS if the agency believes one is necessary to determine whether the benefits of a medication will outweigh its risks. A REMS can include patient package information, a medication guide, a communication plan or a plan for safe use.

Because the REMS is no longer needed for ESAs, the FDA noted that prescribers and hospitals no longer need a specific certification to prescribe and dispense these medications.

If you have any questions about epoetin alfa and darbepoetin alfa, ask your health care provider.