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FDA Approves Spray to Help Control Bleeding During Surgery


The FDA approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery.

 

Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature, or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding.

 

Raplixa contains fibrinogen and thrombin, two proteins found in human plasma, the liquid portion of blood. The two protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the risk for the transmission of blood-borne viruses. The fibrin sealant components are then spray-dried, blended and packaged in a vial. Raplixa can be applied directly from the original product vial or by spraying with a delivery device onto a bleeding site. It is approved for use in conjunction with an absorbable gelatin sponge.

 

“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature.”

 

The most commonly reported adverse reactions were surgical pain, nausea, constipation, fever, and decreased blood pressure.

 

See the FDA Announcement

 

See Medical Law Perspectives March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks

 

See Medical Law Perspectives December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death

 

 

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