FDA approves raplixa to help control surgical bleeding

FDA approves raplixa to help control surgical bleeding

(HealthDay)—Raplixa (human fibrin sealant) has been approved by the U.S. Food and Drug Administration to help control bleeding during surgery, the agency said in a news release.

Raplixa's use is sanctioned when standard surgical techniques—such as suture, ligature, or cautery—are "ineffective or impractical," the FDA said. The spray-dried fibrin sealant is dissolved in the blood and triggers a reaction that promotes clotting. The product contains fibrinogen and thrombin derived from . Its includes purification designed to render blood-borne viruses inactive, the agency said.

Raplixa, designed to be used with an absorbable gelatin sponge, was clinically evaluated among more than 700 people over 11 months. The most common side effects included surgical pain, nausea, constipation, fever, and hypotension.

"The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial," Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature."

The product is manufactured by ProFibrix BV, a unit of The Medicines Company, based in Parsippany, N.J.


Explore further

FDA OKs new adhesive to treat burn victims

More information: More Information

Health News Copyright © 2015 HealthDay. All rights reserved.

Citation: FDA approves raplixa to help control surgical bleeding (2015, May 4) retrieved 14 August 2020 from https://medicalxpress.com/news/2015-05-fda-raplixa-surgical.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
8 shares

Feedback to editors

User comments