The U.S. Food and Drug Administration (FDA) has approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery, the federal agency said on Friday.
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.
As a new blood volume expander manufactured by Fresenius Kabi in Germany, Voluven contains a synthetic starch that does not dissolve in water. It is made by linking individual starch molecules together and combining them with a salt solution, similar to the salt concentration typically found in blood. Voluven expands the volume of blood plasma and thus draws fluid into small blood vessels.
In clinical trials, Voluven was compared to other approved blood volume expanders. During orthopedic surgery, Voluven was as safe and effective in expanding blood volume as Hespan, an approved starch solution.
In newborns and infants undergoing major surgery, Voluven was as safe and effective as an equivalent volume of another expander containing albumin. In other trials, Voluven was as safe as other blood volume expanders used in patients ranging in age from less than 2 years to 75 years who were undergoing a variety of surgical procedures.
(Xinhua News Agency December 29, 2007)
