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Label Changes for:

Evicel (Fibrin Sealant)

April 2010

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Biologics Evaluation and Research (CBER) – April 2010

WARNINGS AND PRECAUTIONS 

Application Precautions 
  • Apply Evicel as a thin layer. Excessive clot thickness may negatively interfere with the product’s efficacy and the wound healing process. 
  • Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer Evicel. This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface. 
  • When applying Evicel using a spray device, be sure to use the pressure within the pressure range recommended by the spray device manufacturer. In the absence of a specific recommendation avoid using pressure above 20-25 psi. Do not spray closer than the distance recommended by the spray device manufacturer. In the absence of a specific recommendation avoid spraying closer than 10-15 cm from the surface of the tissue. When spraying Evicel, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism.

ADVERSE REACTIONS

Postmarketing
  • A post marketing fatality was reported in association with the use of Evicel when applied using a spray device. The case involved an attempt to stop active bleeding by applying Evicel using a spray device attached to a wall unit at a higher than recommended pressure for the spray device. In addition, the spray head was placed at a distance from the bleeding site that was closer than the recommended distance guidelines for the application of the sealant. The patient suffered a fatal air embolism.
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