Oral Lidocaine for Teething Pain May Cause Harm, FDA Says

Megan Brooks

Disclosures

June 26, 2014

Oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain because of a serious risk, the US Food and Drug Administration (FDA) advised in a drug safety communication issued today.

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

This year, the FDA has reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children who were given oral viscous lidocaine 2% solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions.

"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 warns.

The agency said it will require a boxed warning be added to the prescribing information to highlight this risk.

The FDA asks healthcare professionals not to prescribe or recommend oral viscous lidocaine 2% for teething pain. They advise telling parents and caregivers to follow the American Academy of Pediatrics' recommendations for treating teething pain: use a teething ring chilled in the refrigerator (not frozen) or gently rub or massage the child's gums with your finger to relieve the symptoms.

In 2011, as reported by Medscape Medical News, the FDA warned that using over-the-counter benzocaine gels for teething or mouth pain can cause a rare but serious condition called methemoglobinemia.

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