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Health Canada Health products

Benzocaine-Containing Products and the Risk of Methemoglobinemia in Children under Two Years of Age

Issued October 22, 2020
Issue
Benzocaine is known to cause a serious blood condition known as methemoglobinemia (MetHb) both in adults as well as in children. Currently, all benzocaine-containing products (except lozenges) marketed in Canada are required to carry a warning regarding the risk of MetHb. In 2018, Health Canada stopped authorizing benzocaine-containing products for use in children under 2 years of age because the serious risk of MetHb is greater than the benefit, especially since children under 2 years old may be unable to communicate that they are experiencing symptoms of MetHb such as weakness, confusion, headache, and/or difficulty breathing. Health Canada is concerned that children under 2 years of age may still be given benzocaine-containing products despite previous warnings concerning this health risk.
Hazard description
Product safety