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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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FDA Safety Notification: Risk of Life-Threatening Air or Gas Embolism with the Use of Spray Devices Employing Pressure Regulator to Administer Fibrin Sealants - Evicel

September 22, 2009

IMPORTANT DRUG WARNING

SUBJECT: Risk of Life-Threatening Air or Gas Embolism with the Use of Spray Devices Employing Pressure Regulator to Administer Fibrin Sealants

Concerned product: EVICEL® Fibrin Sealant (Human)

Dear Healthcare Professional:

Omrix Biopharmaceuticals Ltd. and Ethicon, Inc., in cooperation with the U.S. Food and Drug Administration (FDA), would like to inform you of an important safety update to the WARNINGS/PRECAUTIONS, Application Precautions (5.2) of EVICEL® Fibrin Sealant (Human) prescribing information. This safety update applies to all fibrin sealants.

The existing Warning and Precaution relating to the application of fibrin sealants has been updated to reflect a post-marketing report regarding the risk of life-threatening air or gas embolism with the use of spray devices employing a pressure regulator to administer fibrin sealants. These events appear to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue.

Specifically, the safety update includes the following instructions for sealant application using a spray device to help prevent air or gas embolism:

  • utilize spray pressure that is within the recommended guidelines by the device manufacturer
  • ensure that distance between the spray head and the application bed is within the recommended guidelines by the device manufacturer
  • monitor patients for the possibility of air or gas embolism
     

Fatality Reported for EVICEL® Fibrin Sealant (Human) Using a Spray Device at Higher than Recommended Pressure and in Close Proximity to the Surface of the Tissue.

The FDA has received a post-marketing fatality report in association with the use 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.

Given the life-threatening and potentially fatal consequences of air or gas embolism, the WARNINGS/PRECAUTIONS, Application Precautions section (5.2) of EVICEL® Fibrin Sealant (Human) prescribing information includes the following important safety update:

5 WARNINGS/PRECAUTIONS
5.2 Application Precautions

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. 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 fibrin sealants 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 the fibrin sealant, 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.

In addition, the Highlights of the Prescribing Information has been updated as follows:
WARNINGS AND PRECAUTIONS

  • Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. These events appear to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue. (5.2)

The updated EVICEL® Fibrin Sealant (Human) prescribing information is enclosed. Please see the EVICEL® Fibrin Sealant (Human) Indication and additional important safety information on page 3 of this letter.

Please contact the ETHICON Customer Support Center at 1-877-ETHICON (877-384-4266) should you have any questions regarding the use of EVICEL® Fibrin Sealant (Human), require further information on product safety, or to report adverse patient experiences.

Reporting Adverse Events to FDA

You are encouraged to report suspected adverse events, regardless of causality to FDA’s MedWatch reporting system

  • By phone (1-800-FDA-1088), by facsimile (1-800-FDA-0178)
  • Online www.fda.gov/medwatch
  • Mailed, using MedWatch FDA 3500 postage paid form, to the FDA Safety Information and Adverse Event Reporting Program, 5600 Fishers Lane, Rockville, MD 20852-9787

Sincerely,

Moshe Kamar, MD Jeffrey
Medical Director & Head of Pharmacovigilance
Omrix Biopharmaceuticals Ltd.

Jeffrey Hammond MD, MPH
Medical Director Johnson & Johnson Wound Management
a division of Ethicon, Inc.

Important Product Information for EVICEL® Fibrin Sealant (Human)
Indication

EVICEL® Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

Important Safety Information

  • For topical use only. Do not inject directly into the circulatory system.
  • Not indicated for the treatment of severe or brisk arterial bleeding.
  • Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
  • Because this product is made from human plasma it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • 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 surface of the tissue. Follow labeled application instructions regarding pressure range and distance when using a spray device and monitor patients for the possibility of air or gas embolism.
  • Anaphylactic reactions may occur.
  • Most common adverse events reported in clinical trials (≥5%) are bradycardia, nausea, hypokalemia, insomnia, hypotension, pyrexia, graft infection, vascular graft occlusion, oedema peripheral, constipation.