FDA issues warning to consumers, healthcare professionals on the use of teething topicals for infants

SILVER SPRING, Md. — The Food and Drug Administration on Thursday notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a boxed warning to be added to the prescribing information label to highlight this information. 

The agency also encouraged parents and caregivers to steer clear of over-the-counter teething remedies like benzocaine "because some of them can be harmful." "FDA previously communicated about safety concerns related to use of OTC topical benzocaine teething preparations," the agency stated. "In 2011, we warned that using OTC benzocaine gels for teething or mouth pain can cause a rare but serious condition called methemoglobinemia. 

“Today’s suggestion from FDA regarding [OTC ingredients like] benzocaine does a disservice to parents and caregivers who use FDA-approved OTC gel and liquid medicines containing benzocaine to treat their children suffering from teething pain," the Consumer Healthcare Products Association released in a statement. "Consumer updates are not the appropriate means to alter the indicated use for FDA-approved medicines, and this suggestion creates confusion among consumers and healthcare providers as well. In 2012, the FDA advised parents and caregivers not to use benzocaine products for children younger than 2 years, unless under the advice and supervision of a healthcare professional. They provided no data as to why they changed the recommendation."

"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," the agency stated. "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."

In 2014, the FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2% solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions. 

Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death, the agency warned.