Blood Clotting Protein Helps Stem Surgical Bleeding
TUESDAY, Aug. 28 -- The U.S. Food and Drug Administration has approved the blood-clotting protein Evithrom (human thrombin) to help stem bleeding during surgery, the agency said Tuesday.
Evithrom is the first form of human thrombin approved since 1954, and is the only form of the human protein currently licensed. Derived from human blood plasma, it is obtained from "carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases," the FDA said in a statement.
The product, applied to the surface of bleeding tissue, is used to stop minor bleeding from small blood vessels when standard surgical techniques are impractical or ineffective.
Forms of thrombin currently used are obtained from cattle. In clinical trials, Evithrom was found "comparable" to the cattle-derived equivalents, the FDA said.
Evithrom is made by the Israeli firm Omrix Biopharmaceuticals and will be distributed domestically by Johnson & Johnson Wound Management of Somerville, N.J.
The FDA has more information about the approval.
Posted: August 2007