FDA OKs Fresenius Drug for Blood Loss
Associated Press 12.27.07, 7:12 PM ET

Government regulators on Thursday approved a blood-thickening solution from Fresenius AG to treat patients who have lost massive amounts of blood.

The injectable fluid, Voluven, is designed to increase the volume of red blood cells and plasma. A rapid drop in blood volume can occur during and after surgery, leading to sometimes fatal shock.

FDA said studies by the Frankfurt, Germany-based company showed the drug was as safe as similar solutions, including Hespan, a drug made by B. Braun Medical Inc. The most common side effects were itching and nausea.

Voluven is made with a synthetic starch that does not dissolve in water.


The drug is not recommended for dialysis patients or those with kidney failure or internal bleeding of the head.



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