I am not sure if somebody has posted this FDA announcement on Voluven. With my very busy schedule in my anesthesiology practice I realized lately that everybody should be aware of this very important alternative to blood transfusion.
The U.S. Food and Drug Administration today (December 27, 2007, with revisions posted Jan 25, 2008 and March 8, 2008)) approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery.
Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so that remaining red blood cells can continue to deliver needed oxygen to the body's tissues.
Voluven is manufactured from a water-insoluble starch modified to form hydroxyethyl starch. "Massive blood loss is a life-threatening problem. Approval of Voluven provides clinicians with an alternative blood volume product that is safe and effective in a wide range of age groups," said Jess L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research .
Voluven has been widely used for this indication in Europe and Asia-Pacific.