The warnings for the medications used to treat certain types of anemia are designed to address the risks the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure, the FDA said.
The labeling changes include a statement that symptoms of anemia, fatigue and quality of life haven't been shown to improve in patients with cancer who are treated with ESAs.
The new boxed warnings emphasize ESAs caused tumor growth and shortened survival in some patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer.
The newly approved boxed warning also clarifies ESAs should only be used in cancer patients when treating anemia specifically caused by chemotherapy and not for other causes of anemia.
The revised labeling provides specific instructions for dosage adjustments and hemoglobin monitoring.
ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells.
The drugs are manufactured by Amgen Inc. (NASDAQ:AMGN)

