ROCKVILLE, Md. -- The FDA today allowed a human thrombin (Evithrom) on the market after the risk of transfusion-transmitted viral infection kept it on the sidelines for more than a half-century.
ROCKVILLE, Md., Aug. 28 -- The FDA today allowed a topical human thrombin (Evithrom) on the market to help reduce minor bleeding during surgery.
The risk of transfusion-transmitted viral infection kept human thrombin on the sidelines for more than a half-century. The alternative was bovine thrombin.
"Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research.
The new Israeli-made agent is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for viral transmission, said the FDA.
In 1954, human thrombin was delicensed, primarily because of the risk of transmitting what was then known as non-A, non-B hepatitis (now hepatitis C). Now, according to the FDA, the human thrombin has dedicated viral inactivation and removal steps.
A recombinant-DNA product, which would be a competitor of human thrombin, is in the final stages of an FDA review.
Human thrombin was 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, said the FDA. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge.
The agency said human thrombin must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal.
In a clinical trial involving several hundred patients, human thrombin was found comparable to cattle-derived thrombin in both safety and effectiveness, said the FDA.