Summary Safety Review - Viscous Lidocaine 2% - Assessing the Potential Risk of Severe Side Effects in Infants and Young Children

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2016-08-29

Product

Viscous Lidocaine 2%

Potential Safety Issue

Severe side effects in infants and young children

Key Messages

  • Viscous lidocaine 2% is used to reduce pain and discomfort in the mouth or to numb an area in the mouth before a medical exam or procedure.
  • A safety review was carried out by Health Canada after the United States Food and Drug Administration issued a safety announcement that this product should not be used in infants and children for teething pain, and that the labels must describe the risk of severe side effects such as seizures, severe brain injury, heart problems and death which have been reported in patients from 5 months to 4 years of age in the United States. No similar cases were reported in Canada.
  • Health Canada's safety review concluded that there is a link between the use of viscous lidocaine 2% and severe side effects in infants and young children. Health Canada is working with the manufacturers of viscous lidocaine 2% products to update the Canadian product information to include these severe side effects.

Overview

Health Canada carried out a safety review to assess the potential risk of severe side effects in infants and young children with the use of viscous lidocaine. The issue was triggered after the United States Food and Drug Administration issued a safety announcement that viscous lidocaine should not be used for teething pain in infants and children. In addition, the Food and Drug Administration required that labels describe the risk of severe side effects in this age group. The severe side effects reported in the United States have not been seen in Canada, but they have been reported in the international medical literature. The current Canadian product information does not recommend the use of viscous lidocaine for teething pain in infants and young children.

In addition, the Canadian Paediatric Society, an association that represents professionals who work with and care for children, have developed teething guidelines a that do not support the use of these products.

Use in Canada

  • Viscous lidocaine 2% is used to reduce pain and discomfort in the mouth or to numb an area in the mouth before a medical exam or procedure in the mouth area.
  • There are 4 non-prescription viscous lidocaine 2% products sold in Canada. They can be obtained without a prescription from a pharmacist.

Safety Review Findings

  • At the time of the review, there were no Canadian cases of serious side effects reported with the use of viscous lidocaine 2% products.
  • The review of the international medical literature showed 13 reported cases of serious side effects with the use of viscous lidocaine 2% products in infants and young children.
  • Although the Canadian product information does not recommend using viscous lidocaine 2% for teething pain, the product labelling and dosing instructions for some products do not specify about how much time should be left between doses. This could lead to high levels of lidocaine in the patient, resulting in the severe side effects reported in infants and young children.

Conclusions and actions

  • Health Canada's safety review concluded that there is a link between viscous lidocaine 2% and severe side effects (seizures, severe brain injury, heart problems, and death) in infants and young children from 5 months to 4 years of age.
  • Health Canada is working with the manufacturers of viscous lidocaine 2% products to update the product information with warnings about the risk of severe side effects in infants and young children and clarify directions for approved uses.
  • Health Canada continues to monitor side effect information involving viscous lidocaine 2%, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Footnotes

  1. a The Canadian Paediatric Society. Caring for Kids: Healthy Teeth for Children.

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