EMA Advises on Safer Use of Fibrin Sealants

Megan Brooks

Disclosures

November 16, 2012

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) today released recommendations to reduce the risk for gas embolism associated with spray application of the fibrin sealants Evicel and Quixil (both Johnson & Johnson Medical Ltd) during surgery.

The agency said a review of these hemostatic agents was initiated after reports of gas embolism occurring 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," the agency said.

"Following review of all available information, the CHMP concluded that the existing instructions for healthcare professionals on the use of these medicines were not sufficient to minimise the risk of this rare but life-threatening adverse effect," the agency noted.

The committee has therefore recommended the following measures to ensure correct use of these medicines when applied as a spray:

  • "Evicel and Quixil should be sprayed using CO2 only, instead of pressurised air, because the greater solubility of CO2 in blood reduces the risk of embolism;

  • 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;

  • 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;

  • the marketing authorisation-holder for Evicel and Quixil should ensure that these products 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."

Healthcare professionals in the European Union will receive a letter explaining these new risk-reduction strategies, as well as new educational material, which the marketing-authorization holder for Evicel and Quixil has committed to develop as a follow-up to this safety review, the European Medicines Agency said.

As previously reported by Medscape Medical News, the US Food and Drug Administration issued an alert more than 2 years ago reminding clinicians to adhere to recommendations regarding proper use of fibrin sprayers.

At the time, the administration said it had received reports of air or gas embolisms and 1 fatality that occurred during or immediately after the application of hemostatic agents using pressurized sprayers.

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