ROCKVILLE, Md., Dec. 28 — Voluven, an intravenous synthetic starch solution, won FDA approval as a blood volume expander for use during and after surgery.
In clinical trials that tested Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) in orthopedic surgery, the product was as safe and effective as Hespan, a starch solution already in use to expand blood volume.
The FDA said that Voluven also demonstrated safety and efficacy when used in newborns and infants undergoing major surgery. In the pediatric studies, the product was compared with an albumin-based blood volume expander.
Moreover, the FDA said, Voluven demonstrated safety in European trials that tested the product in patients ages two to 75.
Blood volume expanders are commonly administered to quickly restore some of the volume lost during surgery so that remaining red blood cells can continue to deliver oxygen to the body’s tissues.
Voluven contains a synthetic starch that does not dissolve in water. It is made by linking individual starch molecules 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 capillaries.
The most common side effects from Voluven were nausea and itching.
Voluven is not recommended for patients with known abnormal sensitivity to the synthetic starch used in the product, those experiencing fluid overload, patients on dialysis, and patients with kidney failure not related to low blood volume.
Nor is it recommended for patients with intracranial bleeding or those with severe increases in serum sodium or chloride.
Voluven was not studied in patients with sepsis but the FDA said a post-market clinical trial involving such patients was planned.
Voluven is manufactured by Fresenius Kabi, Bad Homburg, Germany.