On May 10, 2007, an FDA advisory panel said the use of popular drugs for anemia should be restricted in cancer patients because they may lead to further tumor growth. The advisory committee recommended the manufacturers of the drugs, Amgen and Johnson & Johnson, conduct further clinical studies to test the safety of the drugs, called erythropoiesis-stimulating agents (ESAs) because they are mean to stimulate the growth of red blood cells.

The medications - Epogen and Aranesp, manufactured by Amgen, and Procrit, manufactured by Johnson & Johnson - combined for more than $10 billion in drug sales in 2006, according to data from healthcare information company IMS Health quoted in the Wall Street Journal. Many physicians have prescribed Procrit, Epogen and Aranesp for the anemia caused by cancer itself, but FDA medical officer Vinni Juneja told the panel that the three drugs “do not increase survival and may promote tumor growth” in these patients.

All three drugs received stiffer “black box” warning labels in March 2007 focusing on the cardiovascular and cancer-related risks associated with their use in higher-than-recommended doses. Both manufacturers told the FDA committee that they feel their products are safe when used according to current labeling guidelines. However, the panel voted 15 to 2 for more restrictions of the drugs in cancer patients and unanimously supported further research into the safety of the drugs.

Specifically, the panel said the labels for Epogen, Aranesp and Procrit should set a minimum recommended hemoglobin level at which patients should start the drugs. The drugs should also be discontinued after chemotherapy regimens have finished, and physicians should reassess a patient’s need for anemia therapy at that time.

Source: Anna Wilde Matthews, “Concern Rises Over Anemia Drugs,” Wall Street Journal, May 11, 2007.