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FDA Approves Topical Hemostatic Product

January 18, 2008 -- The U.S. Food and Drug Administration today approved the first clotting solution manufactured using recombinant DNA techniques to help stop small blood vessels from bleeding after surgery.

The new solution, called Recothrom, is a topical thrombin solution. Thrombin is a protein involved in the production of fibrin, a different protein necessary for blood to clot.

Recombinant DNA is the result of a genetic modification process that enables scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.

After surgery, bleeding from small blood vessels, such as capillaries, can cause significant blood loss. Physicians can apply Recothrom during surgery when standard surgical techniques for stopping blood loss are ineffective or impractical.

“With today’s approval, surgeons can choose recombinant thrombin, thrombin derived from human plasma or thrombin derived from cattle plasma to help control surgical bleeding and oozing,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.

Recothrom is made from Chinese Hamster Ovary cells (CHO), which have been genetically modified to produce human thrombin. These CHO cells are free from known infectious agents, and Recothrom undergoes an additional process of viral inactivation.

In a study of 411 patients undergoing various surgical procedures, Recothrom met the primary indicator of effectiveness, which was control of bleeding within 10 minutes. Recothrom was also evaluated on secondary indicators of effectiveness, which were control of bleeding within three and six minutes. These measures of Recothrom’s effectiveness were not inferior to ones displayed by the study’s active control, a licensed topical thrombin derived from cattle plasma.

Adverse events reported during the studies included incision site complications and pain related to the surgical procedure, and nausea.

Recothrom is manufactured by Seattle-based ZymoGenetics, Inc.

Source: Food and Drug Administration

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