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FDA Recommends Not Using Lidocaine to Treat Teething Pain, Requires New Boxed Warning

August 20, 2014

The U.S. Food and Drug Administration (FDA) has warned that prescription oral viscous lidocaine 2 percent solution should not be used to treat infants and children with teething pain.

The FDA is requiring a new Boxed Warning, which is the FDA’s strongest warning, to be added to the drug label to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.

Health care professionals should not prescribe or recommend this product for teething pain. Parents and caregivers should follow the American Academy of Pediatrics’ recommendations for treating teething pain:

  • 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.

The FDA is also encouraging parents and caregivers not to use topical medications for teething pain that are available over-the-counter (OTC) because some of them can be harmful.