FDA: Oral Viscous Lidocaine Should Not Be Used for Kids' Teething Pain — Physician’s First Watch
FDA: Oral Viscous Lidocaine Should Not Be Used for Kids' Teething Pain
By Amy Orciari Herman
Prescription oral viscous lidocaine 2% should not be applied topically to treat teething pain in infants and children, as it may cause serious injury including seizures and death, the FDA warned on Thursday. A black-box warning will be added to the drug's label to emphasize this risk.
An FDA review of adverse events through 2013 identified 22 cases of harm from oral viscous lidocaine 2% in children aged 5 months to 3.5 years: six cases were fatal, three were considered life-threatening, eleven required hospitalization, and two required medical intervention without hospitalization.
The FDA reminds healthcare providers that the drug is not approved to treat teething pain and thus should not be prescribed for this indication. Clinicians should advise parents to follow the American Academy of Pediatrics' recommendations for managing teething pain. These include using a teething ring chilled in the refrigerator (not freezer) and gently massaging the child's gum with one's finger.