FDA Advises Against Topical Medications for Babies’ Teething Pain

FDA-Advises-Against-Topical-Medications-for-Teething-BabiesThe Food and Drug Administration (FDA) has issued a warning to parents about the dangers of using topical pain medication for babies’ teething pain, citing concerns about serious side effects, even death.

The FDA issued a safety warning in June about prescription oral viscous lidocaine 2 percent solution.  The agency said it should not be used to treat teething pain and now requires a boxed warning to highlight the fact that its use in infants and young children can cause serious harm and possibly death. 

Medications that are rubbed on the gums wash out of the baby’s mouth within minutes, so the pain relieving or numbing effect lasts only a short time. When too much viscous lidocaine is used or a child accidentally swallows too much, it can cause seizures, severe brain injury, and problems with the heart. Some lidocaine overdoses have resulted in the child’s hospitalization and the FDA has received reports of six deaths.

The June safety alert also warned of the dangers of over-the-counter products containing benzocaine. OTC benzocaine products for teething or mouth pain can cause a rare but serious condition called methemoglobinemia that results in a large decrease in the amount of oxygen carried through the blood. OTC benzocaine products – in liquid and gel forms – are sold under such brand names as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and as store brands.

The FDA advises health care professionals not to prescribe or recommend any of these products for teething pain. Parents are advised to seek immediate medical attention if their child has a seizure after using one of these medications. To treat teething pain, the American Academy of Pediatrics recommends using a chilled (not frozen) teething ring or gently massaging the child’s gums with a fingertip.

Dr. Patricia Flanagan of Hasbro Children’s Hospital told TV station NBC10 in Providence, Rhode Island, that teething is a “normal process” and parents often don’t even notice it. Because of the dangers of the topical medications, “babies should probably not have medicine for teething pain,” Flanagan said.


This entry was posted in Benzocaine, Health Concerns, Pharmaceuticals. Bookmark the permalink.

© 2005-2020 Parker Waichman LLP ®. All Rights Reserved.