WASHINGTON, June 26 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
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
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
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)