Other safety alerts
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| Canada: Benzocaine products should not be used in children under two years of age |
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Health Canada is reminding parents and caregivers not to use products containing benzocaine in children under two years of age. Benzocaine products may cause a serious blood condition called methemoglobinemia (MetHb), which reduces the ability of red blood cells to deliver oxygen throughout the body.
Over-the-counter (OTC) products that contain benzocaine are used in children and adults for the temporary relief of minor pain from a variety of conditions, including sore throat, toothache, canker sores, and mouth or gum irritation. In the past, OTC benzocaine products were also used to treat teething pain. Benzocaine products are available in a variety of formulations including gels, sprays, swabs, liquids, lotions, creams and lozenges.
Health Canada previously communicated on this safety issue in Nov 2006, April 2011 and introduced new labelling requirements in Apr 2012.
In 2018, Health Canada stopped authorizing benzocaine products for use in children under two years of age. For young children, the serious risk of MetHb is greater than the benefits of benzocaine, especially since children may be unable to communicate that they are experiencing symptoms of MetHb such as weakness, confusion, headache, and/or difficulty breathing.
Most manufacturers of benzocaine products licensed prior to 2018 have added warnings regarding the risk of MetHb and stopped promoting the use of these products in children younger than two years of age. In Aug 2020, Health Canada issued stop-sales for the few existing benzocaine products that had not updated their labelling. Despite these measures, Health Canada is concerned that healthcare professionals, parents and caregivers may be continuing to recommend or use benzocaine products in this age group given its long history of use as a teething pain reliever.
Information for parents and caregivers:
- Parents and caregivers should not use products that contain benzocaine in children under two years of age.
- Consult with healthcare professional for more details on this new safety information or about alternative options to relieve teething pain and other pain in the mouth.
Information for healthcare professionals:
- Products that contain benzocaine should not be recommended for use in children under two years of age.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74129a-eng.php
In Hong Kong, there are 11 registered pharmaceutical products containing benzocaine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to benzocaine.
News related to risk of methemoglobinemia of benzocaine was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 8 Apr 2011, with the latest update posted on 24 May 2018. Letters to inform local healthcare professionals were issued by DH on 8 Apr 2011, 10 Apr 2012 and 24 May 2018. In Jun 2011 and Apr 2013, the Registration Committee of the Pharmacy and Poisons Board (the Committee) discussed the matter, and decided that the labelling of benzocaine products for topical oral use and all benzocaine products except lozenges preparation should contain information on the risk of methemoglobinemia respectively. In Feb 2019, the Committee further discussed the matter, and decided that the sales pack labels and/or package inserts of benzocaine products for topical oral use should include the instruction of do not use for teething and in children under 2 years of age. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Oct 16, 2020
Issued at HKT 16:00
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