EMA Advises on Safer Use of Additional Fibrin Sealants

Megan Brooks

Disclosures

December 14, 2012

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) today recommended a number of new instructions for healthcare providers using the fibrin sealants Tisseel, Tissucol, Artiss (all from Baxter Healthcare), and Beriplast P (and associated names, from CSL Behring).

The instructions are meant to optimize the safe use of these hemostatic agents when applied as spray during surgery, the agency said.

Today's action follows the CHMP advice on 2 other fibrin sealants, Evicel and Quixil (both Johnson & Johnson Medical Ltd), issued on November 16, as previously reported by Medscape Medical News.

The European Medicines Agency initiated a review of fibrin sealants after 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," the agency said.

Although the risk for gas embolism with Tisseel, Tissucol, and Artiss when applied as spray during surgery is considered to be "very low," the CHMP concluded that the risk "cannot be excluded."

They therefore recommend that the product information of these medicines be updated with the following new instructions to optimize their safe use:

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

  • Marketing authorization holders for these medicines should ensure that the sealants 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 for 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 will receive a letter outlining the updated information on the safe use of these medicines, the European Medicines Agency said.

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

In 2010, as reported by Medscape Medical News, the US Food and Drug Administration issued an alert, 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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