FDA Approves Human Thrombin for Topical Use in Surgery

The U.S. Food and Drug Administration today approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery.

Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases.

Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal.

“The approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research. “Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma.”

In a clinical trial involving several hundred subjects, Evithrom was found comparable to cattle-derived thrombin in both safety and effectiveness.

Evithrom is manufactured by Omrix Biopharmaceuticals, Ltd., Ramat Gan, Israel, and will be distributed by Johnson & Johnson Wound Management, a division of Ethicon, Inc., Somerville, N.J.