On June 26, the FDA issued a safety announcement(www.fda.gov) that said health care professionals should not prescribe oral viscous lidocaine 2 percent solution to treat infants and children with teething pain.
The agency's statement explained that rubbing topical pain relievers on a child's gums is not effective because they wash out of the child's mouth within minutes. The FDA went on to warn that if an excessive amount of viscous lidocaine is used, infants and young children can accidentally swallow too much, which can result in seizures, severe brain injury and related heart issues.
So far this year, the FDA has reviewed 22 cases of serious adverse reactions -- including death -- in infants and young children age 5 months to 3.5 years who were given oral viscous lidocaine 2 percent solution to treat mouth pain, including teething and stomatitis, or who had accidental ingestions. According to the safety announcement, the FDA is now requiring the addition of a boxed warning to the label to highlight this information.
The FDA also is recommending that parents and caregivers not use OTC topical medications for teething pain. Instead, the agency suggests following the American Academy of Pediatrics' recommendations(www2.aap.org) to assuage teething pain. These recommendations include
- using a chilled teething ring that is kept in the refrigerator (not frozen), and
- gently rubbing or massaging the child's gums with a finger to relieve symptoms.
In 2011, the FDA issued a warning(www.fda.gov) that using OTC benzocaine gels for teething or mouth pain can cause a rare but potentially fatal condition called methemoglobinemia. According to the current safety advisory, the agency has continued to receive reports of methemoglobinemia in infants and children associated with use of these products since that warning was issued. The products are sold under a number of different brand names, such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase and various store brands.