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FDA Warns Against using Viscous Lidocaine in Infants

Oct 21, 2014

When a baby begins teething, a number of parents may be inclined to use topical viscous lidocaine to numb the gums and relieve pain. The U.S. Food and Drug Administration (FDA), however, warns that use of this product can be harmful and even cause death. In a Safety Announcement issued June 26, 2014, the FDA stated that a new Boxed Warning, the agency’s strongest warning, will be added to the label of oral viscous lidocaine 2 percent solution products to reflect this information.

The Safety Announcement pointed out that the FDA has not approved oral viscous lidocaine for teething pain. Using the product could lead to serious, potentially fatal consequences in infants. According to, Traverse City dentist Dr. Peter Piché said “It’s been shown that when too much Lidocaine Viscous gets swallowed it can cause seizures, brain injuries and problems with the heart,”

“The husband gives it, and the mom doesn’t know that, so she gives more. The product is flavored, so the baby is intentionally licking his gums and swallowing the medicine.” Piché said. “Parents should know that teething pain is a short term thing. It will pass,”

This year, the FDA reviewed 22 reported cases of children and infants who suffered serious reactions, including some deaths, after being given oral viscous lidocaine 2 percent solution. The children, who were between the ages of 5 months and 3.5 years, were given the product for mouth pain, such as teething or stomatitis, or ingested the product accidentally.

In addition to being harmful, the FDA says viscous lidocaine is not even effective at treating gum pain because it washes out of an infant’s mouth within minutes of being administered. “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 alert reads.

The FDA supports the American Academy of Pediatrics’ recommendations for teething pain, which includes using a chilled, but not frozen, teething ring. The Academy also advises gently rubbing or massaging the child’s gums with your finger to reduce the pain.

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