Wednesday, January 2, 2008

FDA OK's Voluven for Post-operative Blood Loss

Filed under: Anesthesiology

The FDA has approved a novel hydroxyethyl starch (HES) solution called Voluven®, from Fresenius Kabi, a Bad Homburg, Germany company, for treatment of post-operative volume loss. This lower substituted hydroxyethyl starch volume expander was found in numerous studies to effectively treat hypovolemia with a minimum number of coagulation side effects, but that is not why the FDA approved it.

From the FDA:

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 -- the liquid portion of the blood -- and thus draws fluid into small blood vessels known as capillaries.

"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 Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

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, a protein found in the blood. In other trials conducted overseas, Voluven was as safe as other blood volume expanders used in those countries in patients ranging in age from less than two years to 75 years who were undergoing a variety of surgical procedures.

Press release: FDA Approves Voluven to Treat Serious Blood Volume Loss following Surgery ...

Abstract: Voluven®, a Lower Substituted Novel Hydroxyethyl Starch (HES 130/0.4), Causes Fewer Effects on Coagulation in Major Orthopedic Surgery than HES 200/0.5 ... Anesth Analg 2001;92:855-862

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