The FDA on Thursday warned that prescription oral viscous lidocaine should not be used to treat infants and young children with teething pain because it can cause serious harm, including death.
The Food and Drug Administration is requiring a boxed warning be added to the drug's label to highlight this information. The FDA's warning follows its review this year of 22 cases of serious adverse reactions, including deaths, in infants and young children 5 months to 3 1/2 years who were given oral viscous lidocaine solution for the treatment of mouth pain or who had accidental ingestion.
Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby's mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.
The FDA also is urging parents and caregivers to not use over the counter topical medications for teething pain because some of them can be harmful.
To treat teething pain, parents and caregivers should follow the American Academy of Pediatrics' recommendations:
- Use a teething ring chilled in the refrigerator (not frozen).
- Gently rub or massage the child's gums with your finger to relieve the symptoms.
