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.

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