The U.S. FDA and European regulatory authorities have been notified about the findings, and Johnson & Johnson indicated in their statement that the drugs should only be used strictly in accordance with their approved indications and dosing recommendations.
Procrit and Epogen are members of a class of medications known as erythropoiesis stimulating agents (ESAs), which also includes Amgen’s Aranesp (darbepoetin alfa) . A number of concerns about potential side effects of these widely used drugs have emerged over the past two years.
In March 2007, the FDA added a “black box” warning to Epogen, Procrit and Aranesp about potential side effects which could increase the risk of blood clots, strokes, heart attacks or death when given at high doses. They have also been linked to an increased rate of tumor growth when given to patients with certain types of cancers.
The manufacturers of these drugs have also faced intense scrutiny surrounding the promotion of these drugs, which has led to wide overuse for unapproved conditions, such as symptoms of anemia. The drug makers have been accused of paying doctors hundreds of millions of dollars each year in return for prescribing the anemia drugs to their patients.