New Recommendations for Safer Use of Fibrin Sealants

The European Medicines Agency (EMA; London, United Kingdom) has recommended a number of measures to minimize the risk of gas embolism when the fibrin sealants Evicel and Quixil are applied as spray during surgery.

Following a review of all available information, the EMA Committee for Medicinal Products for Human Use (CHMP) concluded that the existing instructions for healthcare professionals on the use of these medicines were not sufficient to minimize the risk of pressurized air or carbon dioxide (CO2) gas embolism, a rare but life-threatening adverse effect.

The Committee therefore recommended a number of new risk-minimization measures to ensure correct use of these medicines when applied as a spray. Specifically, the Committee recommended that Evicel and Quixil should be sprayed using CO2 only, instead of pressurized air, because the greater solubility of CO2 in blood reduces the risk of embolism. That the product information of these medicines should be updated with clear and consistent advice for healthcare professionals regarding recommended pressure and distance to use during spraying application. That these medicines should not be sprayed in endoscopic surgery; when used in laparoscopic (abdominal) surgery, care should be taken to ensure that the minimum safe distance from tissue is observed. That the products should be used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and should contain labels stating the recommended pressure and distance.

Evicel was authorized in October 2008 and is available in Austria, Denmark, Estonia, Finland, France, Germany, Ireland, the Netherlands, Spain, Sweden, the UK, and Norway. The marketing-authorization holder for Evicel is Omrix biopharmaceuticals (Somerville, NJ, USA), a Johnson & Johnson (New Brunswick, NJ, USA), company. The marketing-authorization holder is voluntarily withdrawing Quixil from the European market and replacing it by Evicel. The CHMP is also reviewing four other fibrin sealants marketed in the European Union: Tisseel, Tissucol, Artiss, and Beriplast P (and associated names); the review for these medicines is still ongoing.

Fibrin sealants are used in a wide range of surgical procedures to help reduce local bleeding. They can be applied by dripping or spraying the solution onto bleeding tissue, where they form a fibrin clot, stopping bleeding, and thereby helping the wound to heal.

Related Links:
The European Medicines Agency
Omrix biopharmaceuticals
Johnson & Johnson