American soldiers critically wounded in Iraq are being treated with a potent, experimental, blood-coagulating drug despite evidence it can cause clots in the lungs, heart and brain, leading to strokes, heart attacks and death.
The drug, Recombinant Activated Factor VII, was originally designed to treat rare forms of hemophilia and costs $6,000 a dose.
Late last year the Food and Drug Administration (FDA) issued a warning that patients who given the drug without the rare blood disorder, could have strokes and heart attacks and a study by researchers published in January found there were 43 deaths because of clots which developed following injections of Factor VII.
Factor VII is considered by the Army's medical experts to be a medical breakthrough in that it gives front-line physicians a way of control deadly bleeding.
It appears that as many as 1,000 patients in Iraq have been injected with it and though the Army doctors view it as one of the most useful new tools they have, many experts disagree and say it is an irresponsible and inappropriate use of an extremely dangerous drug.
U.S. military doctors in Iraq insist Factor VII saves lives but doctors at military hospitals in Germany and the United States have reported unusual and sometimes fatal blood clots in soldiers evacuated from Iraq, including unexplained strokes, heart attacks and pulmonary embolisms, or blood clots in the lungs and say Factor VII is a suspect.
However doctors say determining the precise cause of blood clots is usually impossible, which makes it difficult to definitively point the finger of suspicion at Factor VII and drawing any firm conclusions.
Doctors and researchers at civilian hospitals, in some hospitals in the U.S. have rejected it as a standard treatment for trauma patients, and other hospitals are cautious about administering it because the drug has never been subjected to a large-scale clinical trial to verify that it is safe for patients without hemophilia.