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.
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(Xinhua News Agency December 29, 2007)