WASHINGTON (Reuters) - The U.S. Food and Drug Administration warned on Thursday against using a lidocaine solution as a pain reliever on teething babies' gums, saying it can cause deaths and serious injuries in infants and toddlers.
The agency will require a boxed warning on the label for prescription oral viscous lidocaine 2 percent solution to highlight that it should not be used for teething pain, the FDA said in a statement.
Viscous lidocaine is normally used to treat mouth or throat ulcers, such as that surface from chemotherapy, or to reduce children's gag reflex during dental procedures.
"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 statement said.
Overdoses or accidental swallowing have led to infants and children being hospitalized or dying, the FDA said.
Pain relievers and medications rubbed on gums are useless because they wash out of the baby’s mouth within minutes, it also warned.
The FDA said it had reviewed 22 reports this year of serious reactions, including deaths, in children ages 5 months to 3.5 years who were given the lidocaine solution or who swallowed it by accident.
The agency urged parents to follow the American Academy of Pediatricians' recommendations for treating teething pain. They call for using a chilled teething ring, or gently massaging the child's gums with your finger.
FDA officials have also recommended against use of benzocaine products for children under age 2 except under a doctor's supervision. Like viscous lidocaine, benzocaine is a local anesthetic.
FDA representatives could not immediately say which pharmaceutical companies make the products that will have to carry the warnings.
Reporting by Ian Simpson; Editing by Susan Heavey