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Factor VII timeline

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• March 1999 -- The U.S. Food and Drug Administration approves Recombinant Activated Factor VII for treating bleeding in patients with rare forms of hemophilia.

• May 1999 -- U.S. Army Col. John B. Holcomb and Israeli Dr. Uri Martinowitz discuss the use of Factor VII in battlefield trauma at a medical conference in Israel.

• June 1999 -- Martinowitz injects two doses of Factor VII into a 19-year-old Israeli soldier who was shot through the abdomen with a high-powered rifle, the first reported use of the drug in a non-hemophiliac. The bleeding "stopped immediately," according to Martinowitz.

• March 2001 -- Holcomb and a group of other American doctors meet in Chicago to begin planning a clinical trial to test Factor VII in trauma patients. The FDA later orders a stop to the effort, citing a lack of evidence that the drug is safe.

• Early 2002 -- An international clinical trial, based at a trauma center in South Africa, begins using the same test proposed by the American doctors.

• February 2004 -- The U.S. Army establishes Factor VII as a standard treatment for wounded soldiers in Iraq, based on unpublished results from the South African study suggesting that the drug is no more dangerous than a placebo.

• February 2005 -- A Columbia University study published in the New England Journal of Medicine suggests that Factor VII is an effective treatment for bleeding in the brain, but with a rate of clot-related complications as high as 10 percent.

• July 2005 -- Results of the 277-patient South Africa trial are published, showing no increased complication rate but also showing little effect on treating patients with penetrating injuries.

• September 2005 -- Researchers at the University of Colorado publish results of a 315-patient survey of Factor VII use in American hospitals, showing a 9.8 percent complication rate caused mostly by "undesirable clotting."

• December 2005 -- The FDA issues a "safety alert" about clots in Factor VII patients without hemophilia, and the drug's label is revised to warn of the potential for heart attacks and strokes.

• January 2006 -- Researchers for the FDA publish a paper in the Journal of the American Medical Association attributing 43 deaths to clots after injections of Factor VII, mostly in patients without hemophilia.

• April 2006 -- Novo Nordisk withdraws a request in Europe for approval of Factor VII to treat bleeding in the brain, after regulators there express concerns about "excessive clotting."

• September 2006 -- Doctors at the R Adams Cowley Shock Trauma Center in Baltimore present results of a study showing an 8.7 percent rate of clot-related complications in their patients given Factor VII, including 12 deaths attributed, in part, to the drug.

Copyright © 2014, The Baltimore Sun
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