FDA Approves Fresenius’ Voluven for Surgical Blood Loss

By Anna Boyd
19:06, December 29th 2007
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FDA Approves Fresenius’ Voluven for Surgical Blood Loss

The U.S. Food and Drug Administration (FDA) has approved a new drug for patients who lose blood before or after a surgery.

The new drug, on its name, Voluven, is manufactured by the German-firm Fresenius  Kabi and is a intravenous solution that expands blood volume, the health agency said on Thursday in a release.

Losing a high quantity of blood can cause a rapid drop in the volume of red blood cells and plasma circulating through the veins of our body. This can further lead to shock, which is potentially fatal.

Voluven has in its composition a synthetic starch that does no dissolve in water. The drug is made by linking individual molecules together and combining them with a salt solution, similar to the salt concentration typically found in blood.

Clinical trials found Voluven to be as safe and effective as other blood expanders such as Hespan, the health agency said. The new drug is also safe when being administered to newborns or young infants.

The same clinical trials revealed that side effects associated with Voluven included nausea and itching. Furthermore, the drug is not recommended for patients on dialysis or those with internal bleeding of the head.

Voluven was not analyzed on patients suffering from sepsis but the FDA said that a clinical trial was planned in this sense.



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