Benzocaine products should not be used in children under two years of age

Starting date:

October 15, 2020

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public, Healthcare Professionals

Identification number:

RA-74129

Last updated:
2020-10-15

Summary

• Product:
  Over-the-counter benzocaine products.
• Issue:
  The risk of methemoglobinemia (MetHb), a serious blood condition that reduces the ability of red blood cells to deliver oxygen throughout the body.
• What to do:
  Parents and caregivers should not use any products containing benzocaine in children under two years of age because of the risk of MetHb. Consult with your healthcare professional for alternative options to treat teething and other pain in the mouth.

• 
  Media enquiries
• 
  Public enquiries

OTTAWA – 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 November 2006, April 2011, and introduced new labelling requirements in April 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 August 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.

Health Canada continues to monitor the safety of benzocaine products, as it does for all health products on the Canadian market, to identify and assess potential risks. Health Canada will take appropriate and timely action if any new health risks are identified.

Information for parents and caregivers:

• Parents and caregivers should not use products that contain benzocaine in children under two years of age.
• Consult with your healthcare professional for more details on this new safety information or about alternative options to relieve teething pain and other pain in the mouth.
• All health products should be stored out of the reach of children to avoid accidental exposure.

Information for healthcare professionals

• Products that contain benzocaine should not be recommended for use in children under two years of age.

Media enquiries

Health Canada

(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991

1-866 225-0709