Off-label use of blood clotting prescription drug may be killing U.S. soldiers, military doctors say

Denmark-based company Novo Nordisk's Recombinant Activated Factor VII was originally designed to coagulate blood and treat rare forms of hemophilia, but reports say that it is being used on critically wounded U.S. troops deployed to Iraq, despite being linked to clots resulting in strokes, heart attacks and death in other patients.

In December, the FDA issued a warning against giving Factor VII to patients who did not have the rare hemophilia -- which affects fewer than 3,000 Americans -- because of the dangerous side effects. FDA scientists also released a January study that blamed 43 blood-clot-related deaths on Factor VII.

The Army medical command, however, considers the drug a medical breakthrough in treating deadly bleeding on the front lines. More than 1,000 patients in Iraq have been treated with the drug.

"When it works, it's amazing," said Col. John B. Holcomb, an Army trauma surgeon and commander of the Army's Institute of Surgical Research. "It's one of the most useful new tools we have."

Military doctors have reported that soldiers who are in need of 10 or more units of blood have between a 25 and 50 percent chance of dying, and Factor VII has proven itself useful in such situations.

"I've seen it with my own eyes," said Lt. Col. Jeffrey Bailey, an Air Force trauma surgeon and senior physician at the American military hospital in Balad, Iraq. "Patients who are hemorrhaging to death, they get the drug and it stops. Factor VII saves their lives."

However, some doctors still stand in opposition of the off-label use of Factor VII.

"It's a completely irresponsible and inappropriate use of a very, very dangerous drug," said blood-clotting and blood-thinning medication specialist Dr. Jawed Fareed, who is director of the hemostasis and thrombosis research program at Loyola University in Chicago.

Some doctors in German and U.S. military hospitals have reported unusual, sometimes fatal, blood clots in soldiers who have been evacuated from Iraq, resulting in unexplained strokes, heart attacks and blood clots in the lungs. A number of doctors fear Factor VII is responsible. The problem is that finding the exact cause of a blood clot is often impossible, which makes it hard to identify any direct relation between clots and Factor VII.

"It's really not a question of an absolute safety level, but rather a ratio of benefit to risk that has to be established," said Dr. Michael Shalmi, vice president of biopharmaceuticals for Novo Nordisk.