FDA NEWS RELEASE

FDA Approves Voluven to Treat Serious Blood Volume Loss following Surgery

This press release contains revisions posted Jan. 25, 2008 and Mar. 7, 2008.

The U.S. Food and Drug Administration today 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. Hydroxyethyl starch-linked units (polymers) increase and maintain blood volume more effectively when used in combination with salt-and-water solutions.

"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 Hetastarch, 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.

The most common side effect from Voluven was itching.

Voluven is not recommended for the following:

• patients with known abnormal sensitivity to the synthetic starch used in the product
• patients experiencing fluid overload
• patients with kidney failure not related to low blood volume
• patients on dialysis
• patients with severe increases in blood levels of sodium or chloride
• patients with bleeding inside the head

Voluven was not studied in patients with sepsis, an infection of the blood. A post-market clinical trial involving patients with sepsis is planned.

Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is manufactured by Fresenius Kabi, Bad Homburg, Germany.

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