Doctors have also been warned that patients should be given the lowest possible dose in order to avoid blood transfusions. The warnings come on the heels of studies that suggest Epogen, Aranesp, and Procrit might cause blood clots, worsen cancer, and increase the risk of death.
A black box warning is the highest level of alert that the FDA uses.
The New York Times reports that the FDA is re-evaluating claims made in advertisements that anemia drugs such as Epogen can raise a patient's energy level or improve a patient's quality of life. The FDA had approved the drugs to reduce the need for blood transfusions but said that manufacturers have not proven that the drugs improve either energy levels or quality of life in patients using chemotherapy.
The biggest risks with Epogen, Aranesp, and Procrit occur when the drug is used to raise the level of hemoglobin to higher than 12 grams per deciliter of blood. Although previous labels carried a recommendation not to exceed that level, the new labels emphasize this warning more strongly.
Epogen is usually used to treat anemia brought on by kidney failure or chemotherapy. The drug is given by injection and used to increase the body's production of red blood cells, which carry oxygen to the body's tissues.
The FDA is concerned that doctors are over-using the anemia medications. A cancer drug advisory committee is scheduled to have a meeting in May to discuss the risks associated with Epogen and other anemia medication.
According to the FDA website, the use of erythropoiesis-stimulating agents (ESAs), which the anemia drugs are, "shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy," "shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy," and "increased the risk of death" for patients with active malignant disease who were not undergoing either chemotherapy or radiation therapy.
In response to the warnings from the FDA, federal health officials are reviewing federal health insurance programs to determine whether or not to continue paying for Aranesp, Epogen, and Procrit.
Even Congress is getting involved, beginning an inquiry into the marketing and regulation of the drugs. Letters were sent to the drug manufacturers requesting that they stop any advertising of the drugs and also stop any incentive programs for doctors until the FDA determines whether or not further safety precautions are required.
Epogen, known generically as epoetin alfa, and Aranesp, known generically as darbepoetin alfa, are sold by Amgen. Procrit, which is also known generically as epoetin alfa, is sold by Johnson & Johnson. The drugs are all forms of erythropoietin (Epo), a protein that is manufactured by the kidney to help with the production of red blood cells.