FDA warns against lidocaine for teething pain

July 10, 2014

Don’t prescribe 2% oral viscous lidocaine to relieve teething pain in infants and children, the US Food and Drug Administration cautions health care providers in a new safety announcement.

Don’t prescribe 2% oral viscous lidocaine to relieve teething pain in infants and children, the US Food and Drug Administration (FDA) cautions health care providers in a new safety announcement. The FDA will require the addition of a boxed warning to the product label.

Oral viscous lidocaine, which isn’t approved for teething pain, can cause seizures, severe brain injury, heart problems, even death, when babies and young children get too much of it. Lidocaine and other topical medications that are rubbed into the gums are washed out of the mouth quickly, limiting their usefulness, the FDA points out.

The FDA warning followed an agency review this year of 22 case reports of serious adverse reactions and deaths in children aged 5 months to 3.5 years who accidentally ingested 2% oral viscous lidocaine or were given the drug to relieve pain from teething or stomatitis.

Health care professionals shouldn’t prescribe or recommend the drug for teething, the FDA advises, and parents and caregivers should also avoid over-the-counter (OTC) topical teething medications. Topical OTC products containing benzocaine have been known to cause local reactions, seizures (with overdose), and methemoglobinemia.

The FDA suggests that parents and caregivers follow the American Academy of Pediatrics recommendations for relieving teething pain-including giving the child a chilled (not frozen) teething ring or gently massaging the gums.

Besides the boxed warning on the lidocaine label, the FDA will mandate that the Warnings and Dosage and Administration sections of the labeling describe the risk of severe adverse events and include additional dosing instructions for when the drug is prescribed for approved uses.

 

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