EMEA recommends new warnings on epoetins

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 stating that blood transfusion should be the preferred method of correcting anemia in this patient group.

Epoetin-containing medicines are indicated in chronic renal failure and for the treatment of anemia in symptomatic patients with non-myeloid tumors on chemotherapy. This drug class includes blockbusters such as Amgen's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) as well as Johnson & Johnson's Procrit (epoetin alfa).

The Committee for Medicinal Products for Human Use (CHMP) reviewed new data from studies that showed an increased risk of tumor progression, venous thromboembolism and shorter overall survival in cancer patients who received epoetins compared to those who did not. Following this review, the CHMP concluded at its June 2008 meeting that their benefits continue to outweigh their risks in the approved indications. However, in cancer patients with a reasonably long life-expectancy, the risk of tumor progression and shorter overall survival is too great and therefore the Committee concluded that, in these patients subjects should be corrected with blood transfusions.