You are here

FDA Issues Alert for Erythropoiesis Stimulating Agents

February 20, 2007 -- FDA is issuing this alert to advise you of results from a large clinical trial evaluating use of an erythropoiesis-stimulating agent (ESA) to treat anemia in cancer patients not receiving chemotherapy. By random assignment, patients received either Aranesp (darbepoetin alfa), an ESA, according to the dosing regimen in approved labeling or placebo. In this study, patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo. ESAs are not FDA approved to treat anemia in cancer patients not receiving chemotherapy. The findings in this study of Aranesp may apply to other ESAs. See the Healthcare Professional Sheet below for more details.

Health care professional sheet in PDF or HTML.

Recent Headlines

Related Settlement Would End Many but Not All Lawsuits
Chronic Kidney Patients With Hyperphosphatemia May Be Another Market for the Drug
Nitrosamine Impurity Also Affects Other Ranitidine Drugs
Mesh Implants, Now Banned by FDA, Work as Well as Hysterectomy
One in Five Kids’ Office Visits Results in an Off-Label Rx
Disrupting Gut Microbiome Could Be Key
Drug Boosts Levels of Natural Endocannabinoids
Judicious Use of Antibiotics May Not Be Enough To Defeat Bacteria That Carry On By Going Into a Dormant State
KRAS Oncogene Is a Problematic Target So Researchers Are Trying Workdarounds