FDA Orders Labeling Changes for ESAs

The FDA is requiring Amgen to modify physician labeling for its erythropoiesis stimulating agents (ESAs) Aranesp and Epogen with a revised boxed warning and a new restricted indication, using language that Amgen has opposed.

The agency used authority it gained through the FDA Amendments Act of 2007 to order the company to make the changes. Amgen has five days to appeal the order or 15 days to update the labels. The company said it would communicate the new labels to physicians soon.

The revised boxed warning and indications section of physician labeling for Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) — both indicated to treat chemotherapy-induced anemia — warn that physicians who expect to cure their patients’ cancer with myelosuppressive therapy should not also prescribe ESAs.

Amgen wanted the boxed warning and new restricted indication to state that, if the anticipated outcome of myelosuppressive therapy is to cure the disease, ESAs are only indicated to treat anemia when red blood cell transfusion is not an option, according to an FDA labeling change order letter.

The letter also orders modifications to the labeling dosage and administration sections for both drugs. The new labels are supposed to state that dosing needs to be initiated when hemoglobin levels are less than or equal to 10 g/dL. Amgen’s proposed statement — “except where the patient is unable to tolerate this degree of anemia due to co-morbid conditions” — which it wanted to immediately follow the 10 g/dL dosing instruction, was rejected by the FDA.