Anemia in the News
European Regulators Adjust Epoetin Drug Recommendations for Cancer Patients
The European Medicines Agency (EMEA) has recommended updating the product information for epoetin-containing medicines with a new warning for their use in cancer patients being treated in Europe. The warning will state that blood transfusion should be the preferred method of correcting anemia in patients suffering from cancer.
EMEA’s advisory committee concluded that in cancer patients with a reasonably long life-expectancy, the benefit of using epoetins does not outweigh the risk of tumor progression and shorter overall survival and therefore anemia should be corrected with blood transfusions. Although blood transfusions should be deemed the preferred treatment, the Committee also concluded, at its June 2008 meeting, that the benefits of epoetins continue to outweigh their risks in the approved patient populations. (Epoetins are approved for use in Europe in patients with chronic renal failure and for the treatment of anemia in symptomatic patients with non-myeloid tumors receiving chemotherapy.)
For patients with cancer, anemia is a common complication and can be treated with either blood transfusion or epoetin administration. When choosing a treatment option, EMEA advises doctors and patients to weigh the risks and benefits of administering epoetins on an individual basis, taking into account the following factors:
- type of tumor
- stage of tumor
- degree of anemia,
- patient’s life-expectancy
- environment in which the patient is being treated, and
- patient preference
In the United States, the Food and Drug Administration (FDA) and the Oncologic Drug Advisory Committee (ODAC) have also been addressing the safety of epoetins for use in cancer patients. Please reference the FDA’s current guidelines for the use of epoetins (also known as ESAs) to treat anemia in the United States. In general, blood transfusions have been used to correct very severe anemia of cancer (hemoglobin level <8 g/dL) and epoetin has been administered when anemia is less severe (hemoglobin level 8-10 g/dL).