The FDA has issued a warning that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain, and that OTC topical medications may also be harmful and should not be used.
The warning was issued after a review of 22 case reports of serious adverse reactions, including deaths, in infants and young children ages 5 months to 3.5 years who were given oral viscous lidocaine 2% solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions. The administration of too much viscous lidocaine in infants and young children or accidentally swallowing too much can result in seizures, severe brain injury, and cardiac issues. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying. A Boxed Warning to the prescribing information will be added per the FDA mandate. The FDA is also encouraging parents and caregivers not to use OTC topical medications for teething pain because some of them can be harmful.
Healthcare professionals are advised to not prescribe or recommend this product for teething pain in infants and children. Parents and caregivers should follow the American Academy of Pediatrics’ recommendations for treating teething pain by using a teething ring chilled in the refrigerator (not frozen) or gently rubbing or massaging the child’s gums with their finger to relieve the symptoms.
For more information visit FDA.gov.