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

Starting date:
October 22, 2020
Posting date:
October 22, 2020
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs, Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Issue:
Important Safety Information, Product Safety, Supply
Audience:
Healthcare Professionals
Identification number:
RA-74173

Last updated:

Audiences

Healthcare professionals including family physicians, general practitioners, dermatologists, pediatricians, dentists, nurses, and pharmacists.

Key messages

  • Benzocaine has been associated with methemoglobinemia (MetHb), a serious, potentially life-threatening adverse reaction. 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.
  • Healthcare professionals are reminded to NOT recommend benzocaine-containing products for children under 2 years of age.
  • In 2018, Health Canada stopped authorizing these products for use in children under 2 years of age, because the benefits of these products do not outweigh the serious risk of MetHb in this age group, especially as children under 2 years old may be unable to communicate that they are experiencing symptoms of MetHb.

   

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.

Products affected

Over-the-counter benzocaine-containing products.

Background information

Over-the-counter (OTC) benzocaine-containing products are available in different formulations (gels, sprays, swabs, liquids, lotions, creams and lozenges) and are commonly used for the temporary relief of minor pain due to a variety of conditions, including, sore throat, toothache, canker sores, and mouth or gum irritation. OTC benzocaine-containing products have also been used to treat teething pain. 

Benzocaine has been associated with methemoglobinemia (MetHb), a serious blood condition that reduces the ability of red blood cells to deliver oxygen throughout the body. Health Canada previously communicated on this safety issue in April 2012, April 2011 and November 2006.

In 2012, Health Canada requested manufacturers of all benzocaine-containing products (except lozenges) to add new warnings regarding the risk of MetHb to the packaging and labelling. The warnings included a statement to consult a healthcare professional prior to using these products in children less than 2 years of age.

The US Food and Drug Administration issued a Drug Safety Communication (DSC) in 2018 warning about the rare, but serious, potentially fatal adverse reaction MetHb with the use of benzocaine products (gels, liquids and sprays) applied to the gums or mouth, or used for medical procedures. The DSC warned that these products should no longer be used in infants and children less than 2 years of age due to an unfavourable benefit-risk profile, and to use caution when used in older children and adults.

In 2018, Health Canada decided to stop authorizing benzocaine-containing products for children under 2 years of age because:

  • the benefits of these products do not outweigh the serious risk of MetHb in children younger than 2 years of age.
  • the warnings for MetHb directed to parents/caregivers are insufficient, as children under 2 years of age may be unable to communicate that they are experiencing symptoms of MetHb like weakness, confusion, headache, and/or difficulty breathing.

Most of the manufacturers of benzocaine-containing products, which were licensed prior to 2018, have added the warnings regarding the risk of MetHb and stopped promoting the use of these products in children younger than 2 years of age. In August 2020, Health Canada issued stop-sales for the few existing benzocaine-containing products that had not updated their labelling.

Despite these measures, Health Canada is concerned that healthcare professionals and parents/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.

Who is affected

Information for consumers

Over-the-counter (OTC) benzocaine-containing products are available in different dosage forms (gels, sprays, swabs, liquids, lotions, creams and lozenges) and are commonly used for the temporary relief of minor pain from a variety of conditions, including, sore throat, toothache, canker sores, and mouth or gum irritation. OTC benzocaine-containing products have also been used to treat teething pain.

OTC benzocaine-containing products have been associated with methemoglobinemia (MetHb). MetHb is a serious blood condition that reduces the ability of red blood cells to deliver oxygen throughout the body.

Since 2018, Health Canada has not authorized the use of any benzocaine-containing products for children under 2 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. Parents and caregivers are advised not to use benzocaine-containing products in infants and children under 2 years old.

Parents and caregivers should contact their 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

Healthcare professionals are reminded to NOT recommend benzocaine-containing products for children under 2 years of age.

Action taken by Health Canada

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-containing products for use in children under 2 years of age. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect™ e-Notice email notification system, as well as through social media channels, including LinkedIn and Twitter.

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare professionals and consumers reporting adverse reactions and medical device incidents. Any case of serious or unexpected side effects, including MetHb, in patients receiving benzocaine-containing products should be reported to respective product manufacturers or Health Canada.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate
E-mail: hc.mhpd-dpsc.sc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738