FDA Drops Prescriber Training for ESAs in Chemo Patients

April 13, 2017

The US Food and Drug Administration (FDA) announced today that it no longer requires special training for clinicians to prescribe erythropoiesis-stimulating agents (ESAs) for chemotherapy-related anemia.

The FDA has concluded that clinicians now have a better handle on prescribing ESAs appropriately and explaining their considerable risks to patients.

The ESAs in question are epoetin alfa (Epogen and Procrit) and darbepoetin alfa (Aranesp), all made by Amgen. Like the human protein erythropoietin, ESAs stimulate bone marrow to make red blood cells. Both agents are indicated to treat anemia induced by chemotherapy when a cure is not expected or chronic kidney disease. The FDA also approved epoetin alfa to treat anemia related to zidovudine therapy for HIV and to reduce the number of blood transfusions during and after certain surgeries.

Boxed warnings on the labels of these ESAs note that the agents increased the risk for tumor progression or recurrence in patients with cancer and shortened their survival in clinical trials. With these issues in mind, the FDA ordered a risk evaluation and mitigation strategy (REMS) in 2010 for oncologists who prescribe epoetin alfa and darbepoetin alfa for patients with chemotherapy-induced anemia. Under the REMS, these clinicians had to receive extra training on both administering the drugs and counseling patients about their risks, benefits, and permitted uses. 

In a news release today, the FDA said that the REMS was no longer needed to ensure that the benefits of ESAs outweigh their risks. The FDA based this decision on an Amgen study of the REMS as well as its own analysis of how various regulatory actions have affected the use of ESAs. 

According to the drug manufacturer's study, surveyed prescribers demonstrated "acceptable knowledge" about the risks of ESAs and the need to communicate them to patients. In addition, "drug utilization data indicates appropriate prescribing of ESAs consistent with the intended use as a treatment alternative to [red blood cell] transfusion for anemia associated with myelosuppressive chemotherapy." 

An FDA evaluation of ESA prescribing trends found an increase in the proportion of patients who begin taking the agents at the correct dosage and at the indicated hemoglobin level, which is less than 10g/dL. Also, the proportion of patients undergoing chemotherapy who use ESAs decreased. The FDA said the REMS had minimal impact on these trends, leading the agency to conclude that it is no longer necessary to certify clinicians to prescribe ESAs. 

However, the risk for shortened survival and higher risk for tumor progression or recurrence haven't gone away, and clinicians need to counsel patients about that, the agency said. 

More information about today's announcement is available on the FDA website.

To report any problems with ESAs, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Follow Robert Lowes on Twitter @LowesRobert


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