Drug for Troops Labeled Dangerous

BALTIMORE (AP) — A blood-coagulating drug designed to treat rare forms of hemophilia is being used on critically wounded U.S. troops in Iraq despite evidence it can cause clots that lead to strokes, heart attacks and death in other patients, The (Baltimore) Sun reported for Sunday's editions.

Recombinant Activated Factor VII, which is made by Danish pharmaceutical company Novo Nordisk, is approved in the United States for treating forms of hemophilia that affect fewer than 3,000 Americans. It costs $6,000 a dose.

The Food and Drug Administration said in a warning last December that giving Factor VII to patients who don't have the blood disorder could cause strokes and heart attacks. Its researchers published a study in January blaming 43 deaths on clots that developed after injections of Factor VII.

However, the Army medical command considers it a medical breakthrough that gives front-line physicians a way to control deadly bleeding. Physicians in Iraq have injected it into more than 1,000 patients, reported The Sun, which makes its first Sunday edition available Saturday afternoon.

"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."

Critics strongly disagree.

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

Military doctors said patients requiring transfusions of 10 or more units of blood have a 25 percent to 50 percent chance of dying from their injuries, and there is enough evidence of the drug's effectiveness to continue promoting its use.

"I've seen it with my own eyes," said Air Force Lt. Col. Jeffrey Bailey, a trauma surgeon deployed this summer as 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, 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 some have begun to suspect Factor VII, The Sun reported.

Contacted Saturday by The Associated Press, an Army spokeswoman, Mary Ann Hodges, declined to comment immediately on the report because she had not seen it.

Doctors say determining the precise cause of blood clots is rarely possible, making it difficult to establish definitively whether Factor VII is responsible for complications. And military doctors caution against drawing any conclusions from individual cases.

Officials at Novo Nordisk said complications don't mean the drug is too dangerous to use.

"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.

"We're making decisions, in the middle of a war, with the best information we have available to us," said Holcomb at the Army's Institute of Surgical Research.

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