US FDA calls for stronger warnings on ESAs Aranesp, Epogen and Procrit

Following concerns earlier this year about the safety of erythropoiesis-stimulating agents (Marketletters February 26 and March 19), the US Food and Drug Administration has approved revised boxed warnings - the most serious that a drug can carry - and other safety-related labeling changes for these products, which treat certain types of anemia.

These new statements address the risks that biotechnology major Amgen's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and health care giant Johnson & Johnson's and Procrit (epoetin alfa) pose to patients with cancer and chronic kidney failure. The drugs have been linked to higher tumor growth rates and increased risk of death in cancer patients.

An FDA panel recently voted against restricting the dosage of ESAs (Marketletter September 17). Prior to the problems, the three products generated combined annual sales of some $10.0 billion, but these have dwindled somewhat, and the latest FDA move is unlikely to help the situation. Amgen and J&J's Ortho Biotech subsidiary have both announced that they have updated the US prescribing information for their products in accordance with the FDA's requirements.