其 他 安 全 警 示
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| Singapore: Benzocaine and the risk of methaemoglobinaemia (English Only) |
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HSA would like to inform healthcare professionals of the risk of methaemoglobinaemia associated with the use of benzocaine containing products. A review of the US cases indicated that methaemoglobinaemia may occur following a single administration of the benzocaine spray and may not be related to the amount applied. Benzocaine is commonly administered orally as lozenges or applied topically as a gel or spray to relieve pain from a variety of conditions such as teething, canker sores, sore throat, irritation of the mouth and gums or during medical procedures to numb mucous membranes of the mouth and throat. Methaemoglobinaemia is a rare but serious and potentially fatal condition in which there is a reduction in the oxygen-carrying capacity of the blood. Signs and symptoms (including cyanosis, dyspnoea, lightheadedness, fatigue, decreased blood oxygen saturation levels and tachycardia) usually appear within minutes to hours after benzocaine administration and may occur after first application or following repeated use.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/
safety_information/product_safety_alerts/safety_alerts_2011/benzocaine_and_the.html
In Hong Kong, there are two pharmaceutical products containing benzocaine registered for topical oral use. Both products are part I poison and should be sold under the supervision of a pharmacist. The news has been released by the US FDA, Health Canada and China SFDA and was posted on the website of pharmaceutical service on 8 April 2011, 20 April 2011 and 14 July 2011. Press release and letter to inform the healthcare professionals were issued on 8 April 2011. The issue was discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board on 11 May 2011 and the Committee decided that appropriate warnings should be included in the labels/package inserts of products containing benzocaine for topical oral use.
Ends/ Friday, August 5, 2011
Issued at HKT 15:00
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