Black Box Warning Ordered for Aranesp, Epogen, and Procrit - Part III
Karen Weiss, M.D., deputy director of the FDA's Office of Oncology Drug Products, said the FDA became concerned when it started to receive results from a number of trials investigating aggressive use of erythropoiesis-stimulating agents to raise hemoglobin to targets higher than the targets on the drug label.
The results of those "more is better" studies were uniformly bad-ranging from increased cardiovascular events to progression of cancer.
A puzzling aspect of the FDA action today was the acknowledgement that there was no evidence to support marketing claims that the drugs could restore energy or reduce fatigue for patient in chemotherapy or radiation therapy.
Rafel Dwain Rieves, M.D., acting director, division of medical imaging and hematology products, said those claims were an extension of quality-of-life labeling from studies in renal dialysis patients.
But Dr. Rieves said that even the renal labeling was not supported by good quality-of-life measures, but rather results of a series of questionnaires that asked open-ended questions about a wide range of topics including sex life, appetite, happiness, and energy.
Dr. Pazdur said that going forward, all patients should be started on the lowest possible dose of Aranesp, Epogen, or Procrit.