A black-box warning issued by the FDA may curtail aggressive use of marketed anemia drugs Aranesp and Epogen from Amgen, as well as Procrit, sold by Johnson & Johnson's Ortho Biotech unit.
The revised product labeling for erythropoiesis-stimulating agents (ESAs) recommends physicians monitor red blood cell levels (hemoglobin) and to adjust the ESA dose so as not to exceed recommended levels.
Studies showed 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 higher doses.
Increased risks were reported in other uses, as well, such as in patients with cancer who were not receiving chemotherapy and in patients following orthopedic surgery.
The label change, which Amgen and J&J have agreed to, came ahead of a planned meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss revisions to the labeling of ESAs. The FDA left the door open for further labeling revisions once that meeting occurs.
In addition to the three products already on the market, Roche is planning to launch its ESA product, Cera, this spring.
Even though the FDA warning is confined to uses not approved by the drugs' label, it's still expected to take a bite out of the companies' sales. Analyst Gene Mack of HSBC Securities said that the warning could reduce Amgen's sales by 10%, or $700 million this year, wrote The Wall Street Journal. Aranesp and Epogen accounted for $5.3 billion in US sales last year, while Procrit had $2 billion in US sales.