Lidocaine Viscous: Boxed Warning Required – It Shouldn't Be ...

Lidocaine Viscous: Boxed Warning Required – It Shouldn’t Be Used to Treat Teething Pain

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Pediatrics, Family Practice healthcare personnel and consumers are informed by the FDA that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain.

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FDA Alert on Lidocaine Viscous

FDA’s reason for the warning is that, in 2014, the Agency reviewed 22 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% to treat mouth pain, or who had accidental ingestions.

If infants and young children are given too much viscous lidocaine or they accidentally swallow too much, this can lead to severe brain injury, seizures, and heart problems. A relative Boxed Warning is required by the Agency to be added to the prescribing information of viscous lidocaine.

FDA Recommendation on Lidocaine Viscous

“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.

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. FDA recommends following the American Academy of Pediatrics’ recommendations to help lessen teething pain.”

Contacting the FDA to report cases with Lidocaine Viscous

In case of detection of adverse events or side effects related to the use of Lidocaine Viscous, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

  • The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm
  • The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form
  • The completed form can be faxed to: 1-800-FDA-0178

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