Black Box Warning Ordered for Aranesp, Epogen, and Procrit - Part I
ROCKVILLE, Md., March 9 -- The FDA warned today that aggressive use of erythropoiesis-stimulating agents to raise hemoglobin to a target of 12 g/dL or higher was associated with "serious and life-threatening side-effects and/or death."
The agency ordered a black-box warning for the drugs that recommended the lowest possible dose to slowly raise the hemoglobin concentration to the lowest level that will avoid the need for a blood transfusion.
Moreover, the FDA said that there has never been any evidence to support claims made in direct-to-consumer advertising that treatment with darbepoetin (Aranesp), epoetin alfa (Epogen), or epoetin alfa (Procrit) could increase energy or ease fatigue in patients undergoing cancer therapy.
For cancer patients who are not on chemotherapy, the FDA said that erythropoiesis-stimulating agents did not benefit anemia. But they appeared to shorten time to death.