WASHINGTON—The U.S. Food and Drug Administration (FDA) said yesterday it would review the safety of Amgen’s Aranesp and Epogen and Johnson & Johnson’s Procrit anemia drugs after clinical trials raised "major concerns regarding the use of ESAs to increase hemoglobin concentrations" in chronic kidney disease patients above levels needed to avert blood transfusions.
In an article published in the New England Journal of Medicine yesterday, FDA "anticipates convening a public advisory committee meeting in 2010 to reevaluate the use of drugs known as erythropoiesis-stimulating agents (ESAs) in people with chronic kidney disease.
As reported by Reuters, FDA Spokeswoman Karen Riley said an "important question" for the advisory panel would be what level of hemoglobin doctors should try to achieve with the drugs. The medicines raise levels of oxygen-carrying hemoglobin in the blood. The FDA officials, in the journal article, said "optimal hemoglobin targets have never been established" for patients with chronic kidney disease.
"Beyond lowering hemoglobin targets and reducing doses of ESAs, it is also possible that more frequent hemoglobin monitoring" and other dosing changes might "improve outcomes" for patients, the FDA officials said.
