Amgen’s three treatments - Aranesp and Epogen, as well as Procrit (which is actually sold by Johsnon & Johnson’s Ortho-Biotech unit) - all get updated warnings, a new boxed warning, and modifications to dosing instructions. The boxed warning advises docs to monitor red blood cell levels (hemoglobin) and to adjust the dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions. Doctors aretold to carefully weigh the risks of ESAs against transfusion risks.

This is the fourth time the labels have been revised. Why the latest action? Recently completed studies describe an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses. In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses.

“The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies,” says Steven Galson, director of the agency’s drug center. “The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the oncologic drugs advisory committee meets in May and further revisions to the labeling may occur after that meeting.”

This isn’t good news for Amgen, which will post a ‘Dear Doctor’ letter on its web site. But this step has been anticipated, given recent controversy over dosage guidelines and the studies.

Amgen statement;
FDA press release;
Forbes: Amgen’s Latest Mess;
The New York Times: Treatment of Anemia Questioned;
The New York Times: Heart Risk Seen in Anemia Drug.

[tags]Amgen, Aranesp, Epogen, FDA, Ortho-Biotech, Procrit, Safety[/tags]