Recombinant Activated Factor VII, a blood coagulant made by Danish pharmaceutical company Novo Nordisk and sold under the name NovoSeven, was approved only for treating people with a rare form of inherited hemophilia when it was introduced in 1999.
However, when trauma specialists for the American and Israeli militaries decided that the drug might save wounded soldiers on the battlefield, it began being used for a vastly different purpose.
The drug, which is still only approved for treating hemophiliacs, has now been administered to more than 1,000 wounded American troops in Iraq and more than 300 bombing victims in Israel. But many hematologists and blood specialists think that the drug may be killing patients by creating blood clots that travel to the heart, brain and lungs.
The opinion among these blood experts is borne out by an FDA warning issued nearly a year ago, which noted that giving NovoSeven to patients without hemophilia can be deadly (43 deaths, mostly among non-hemophiliacs, were blamed on clots). Similar dangerous side effects have been observed by doctors treating wounded soldiers evacuated from Iraq in military hospitals.
If the drug is approved for all patients, it could bring in profits of $2 billion each year.
