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FDA Recommends Not Using Lidocaine to Treat Teething Pain

Agency requires new boxed warning

The FDA has warned that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. The agency is requiring a new boxed warning to be added to the drug label to highlight this information.

Oral viscous lidocaine solution is not approved to treat teething pain, and its use in infants and young children can cause serious harm, including death, the FDA says.

According to the agency, health care professionals should not prescribe or recommend the product for teething pain. Parents and caregivers should follow the American Academy of Pediatrics’ (AAP) recommendations for treating teething pain:

  • Use a teething ring chilled in the refrigerator (not frozen).
  • Gently rub or massage the child’s gums with a finger to relieve the symptoms.

In the FDA’s opinion, topical pain relievers and medications that are rubbed on the gums of infants 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.

In 2014, the FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2% solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions.

In addition to the boxed warning, the agency is requiring revisions to the “warnings” and “dosage and administration” sections of the drug label to describe the risk of severe adverse events and to include additional instructions for dosing when the drug is prescribed for approved uses.

The FDA is also encouraging parents and caregivers not to use topical medications for teething pain that are available over the counter because some of them can be harmful. The agency advises following the AAP recommendations listed above to help lessen teething pain.

Source: FDA; August 26, 2014.

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