Additional ESA safety information

The FDA is reviewing new data regarding the risks of erythropoiesis-stimulating agents (ESAs) used to treat anemia. Two studies showed that patients with breast or advanced cervical cancers, who received ESAs to treat anemia caused by chemotherapy, died sooner or had more rapid tumor growth than similar patients who didn't received the anemia drug. These two studies were not among the six previously described in November 2007. The FDA plans to discuss this new data and revisit the risks and benefits of using ESAs in patients with chemotherapy-induced anemia

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152281.htm.