Topical Painkillers for Teething Pain May Cause Serious Harm, FDA Warns

FDA issues warning of possible serious reactions to oral lidocaine to treat teething pain in infants and young children

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration (FDA) is warning that a certain oral pain reliever should not be used to treat infants and children with teething pain.

According to the FDA, doctors should not prescribe oral viscous lidocaine 2 percent solution to these young patients because it can cause serious harm and even death.

This topical pain reliever is not approved for treating teething pain.

"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," the FDA reported in a press statement.

The FDA is requiring that a Boxed Warning outlining these potential harms be placed on the drug label of oral viscous lidocaine 2 percent solution. A Boxed Warning is the FDA's strongest warning.

This warning stems from a recent FDA review of 22 case reports of serious reactions to oral viscous lidocaine 2 percent solution in infants and children aged 5 months to 3.5 years.

The FDA says that parents and caregivers should follow the American Academy of Pediatrics' guidelines for treating teething pain. To relieve symptoms, these guidelines recommend using a teething ring chilled, but not frozen, in the refrigerator and gently rubbing or massaging the child's gums with a finger.

Review Date: 
June 26, 2014
Last Updated:
June 26, 2014