Off-label use of erythropoiesis-stimulating agents (ESAs), a class of genetically engineered drugs for treatment of anemia, increases mortality and morbidity risk, warns the US Food and Drug Administration (FDA).
The warning follows publication late last year of studies suggesting that correction of anemia in patients with chronic kidney disease did not reduce the risk of cardiovascular events and that reaching a target hemoglobin level of 13.5 g/dL, compared with a target level of 11.3 g/dL, was associated with increased risk of cardiovascular events. Earlier this year, the FDA was also notified of several studies involving patients with cancer treated for anemia—studies that suggested ESAs increased various health risks.
Mitka M. FDA Sounds Alert on Anemia Drugs. JAMA. 2007;297(17):1868-1869. doi:10.1001/jama.297.17.1868