ADR that result in revision of patient information
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| European Union: European Medicines Agency recommends new measures for the fibrin sealants Evicel and Quixil to minimise the risk of gas embolism when these medicines are applied as spray during surgery |
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a number of risk-minimisation measures for the fibrin sealants Evicel and Quixil to minimise the risk of gas embolism when these medicines are applied as spray during surgery.
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 solution is currently sprayed using either pressurised air or carbon dioxide (CO2).
The review of these medicines was initiated following 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.
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 Committee therefore recommended a number of new risk-minimisation 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 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.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_001659.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 3 pharmaceutical products registered under the name of Evicel Solutions for Sealant (1ml: HK-61387, 2ml: HK-61386 and 5ml: HK-61369) and all are prescription-only medicines. There is no record of pharmaceutical product registered under the name of “Quixil” in Hong Kong. The Drug Office has not received any adverse drug reaction report in connection with the products. In view of the EMA's recommendation, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, November 17, 2012
Issued at HKT 12:00
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