Don’t use oral benzocaine products for teething, FDA warns

Products carry serious risks, provide little to no benefit

In May, FDA issued a safety communication warning health professionals and consumers that OTC benzocaine products should not be used in infants and children younger than 2 years and should only be used in adults and children older than 2 years if there are certain warnings on the drug label. FDA also urged manufacturers to add warnings to their products’ labels about benzocaine’s potential to cause methemoglobinemia, a serious condition that changes the transport of oxygen to body tissues.

“These products carry serious risks and provide little to no benefits for treating oral pain,” the statement says. “Due to the significant safety risk of methemoglobinemia, we have urged manufacturers [to] stop marketing OTC oral drug products for treating teething in infants and children younger than 2 years. If companies do not comply, we will take action to remove these products from the market.”

Serena Huntington, PharmD, CSPI, managing director at the California Poison Control System–Madera division at Valley Children’s Hospital, said that the way oral benzocaine products are marketed can give parents a false sense of security.

“Oral gels and teething gels have pictures of babies on the packaging, so people think it’s safe. They think, ‘They wouldn’t give me something that is toxic for my child,’ ” Huntington said.

Huntington added that it’s easy to use too much of the products. “Parents put it on their child’s gums, and the child is fine for 15 minutes. Then the child fusses again, so the parent puts more on. It’s therapeutic error. They think more is better, so they overdose their child.”

The consistency of oral gels contributes to potential overdosing, said Edward Bell, PharmD, BCPS, professor of pharmacy practice in the Department of Clinical Sciences at Drake University College of Pharmacy and Health Sciences in Des Moines.

“Babies swallow it, or it can wash out of their mouths, so then the parents think they didn’t give enough, so they’ll give some more, and the next thing you know, it’s too much,” Bell said.

Communicating with parents about oral benzocaine products presents a challenge because they can simply grab a product off the shelf and head up to the register without going near the pharmacy. Huntington suggests being proactive in alerting parents.

“You could put a sign up that says, ‘Child teething? Come to the pharmacist to discuss your options.’ Or you could post the FDA warning, which may prompt questions about why they should or shouldn’t use [these products],” Huntington said. “[Another option is] when you talk to parents about child-resistant caps, you can ask if they have any children who are teething.”

Bell encourages pharmacists to be prepared with options for parents of teething children.

“The best treatments, the ones that the American Academy of Pediatrics recommends, are basically non-drug treatments, like a teething ring for the child to chew on,” Bell said.

“Anything cold and hard could work—a cold washcloth the child can chew on, or a cold teething ring. Parents can also wash their hands and use their fingers to rub the child’s gums. But no ice cubes, and nothing they can swallow,” Huntington said.

For the full article, please visit for the August 2018 issue of Pharmacy Today.