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Updated advice to reduce risk of gas embolism during spray application

EMA recommends new advice on safer use of fibrin sealant spray applications

London, UK (December 14, 2012) – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a number of new instructions for healthcare professionals using the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names) to optimise the safe use of these medicines when applied as spray during surgery.

This follows the CHMP advice on two other fibrin sealants, Evicel and Quixil, adopted in November 2012.

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.

The review of fibrin sealants was initiated following reports of gas embolism with Evicel and Quixil in association with the use of spray devices that use a pressure regulator to administer these medicines. These events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in closer-than-recommended proximity to the tissue surface.

Although the risk of gas embolism with Tisseel, Tissucol and Artiss when applied as spray during surgery was considered to be very low, the Committee concluded that the risk cannot be excluded, and recommended that the product information of these medicines be updated with new instructions to optimise their safe use. These include:

The product information should be updated with clear and consistent advice for healthcare professionals regarding recommended pressure and distance to use during spraying application.

The marketing-authorisation holders for these medicines should ensure that they are used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that they contain labels stating the recommended pressure and distance.

The product information should include a warning that the risk of gas embolism appears to be higher when fibrin sealants are sprayed using air, as compared to CO2, and patients should be closely monitored for signs of gas embolism.

Healthcare professionals in the European Union (EU) will receive a letter outlining the updated information on the safe use of these medicines.

For the fibrin sealant Beriplast P (and associated names), however, the CHMP concluded that there is no risk associated with this product because it does not require a gas-assisted spray device during application, therefore there is no risk of gas embolism with this product when used in accordance with prescribing advice and with the recommended device.

European Medicines Agency (EMA), 14.12.2012 (hB).