FDA mandates changes to ESA labeling info

New labeling for Aranesp and Procrit will tighten the use of both medications in cancer patients. The Food and Drug Administration ordered Amgen of Thousand Oaks, California to make changes to the prescribing information for its anemia drug darbepoetin alfa (Aranesp). Johnson & Johnson’s Ortho Biotech had already accepted the changes for the labeling of its ESA epoetin alfa (Procrit).

The labels must now state that treatment with an ESA should not be initiated unless hemoglobin levels drop below 10 g/dL. FDA also requested the removal of language that implies that ESAs are safe to use until a patient’s hemoglobin level rises to 12 g/dL. In addition, the labeling must state that ESAs should not be used in patients receiving myelosuppressive therapy when the expected outcome is cure.

The changes do not include all of the recommendations made in March by FDA’s Oncologic Drugs Advisory Committee. ODAC had recommended that patients with advanced breast cancer or head-and-neck cancer should not receive ESAs.

This is the first time that the agency has invoked a 2007 law that allows it to force companies to make changes to prescribing information rather than negotiate changes. In a statement, Amgen said, “This label is consistent with our expectations.”