New U.S. Restrictions On Aranesp, Epogen?

It has been reported that the United States' Food and Drug Administration is concerned that erythropoiesis-stimulating agents (ESAs) such as Epogen, Aranesp and

Procrit are increasing the risks of strokes and other cardiovascular problems in humans.

According to an article by The Wall Street Journal, the FDA has asked an advisory panel for the appropriate use of the drugs in light of the stroke and cardiovascular issues. The drugs are used to fight anemia and kidney disease.

The article states that the results from a recent clinical trial known as TREAT -- which looked at Aranesp used for patients with kidney disease that weren't on dialysis -- didn't meet a study goal of reducing death and cardiovascular events in patients whose hemoglobin levels were targeted at 13 grams per deciliter of blood (the current drug labels recommend not exceeding 12). It also showed patients treated with Aranesp had double the rate of strokes compared with patients not receiving the drug.

Aranesp and EPO made major headlines in the horse racing industry just a few years ago, as major fines and suspensions were handed down by the Ontario Racing Commission to those found guilty of having a connection to the drugs' presence in racehorses.

(With files from The Wall Street Journal)