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

View metadata and access the original English HTML file: Summary Safety Review - Viscous Lidocaine 2% - Assessing the Potential Risk of Severe Side Effects in Infants and Young Children.

Format

HTML

Access

file-only

Publisher-reported update

2024-05-10

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.

Access original file