Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug information. On June 26, 2014, FDA warned that prescription oral viscous lidocaine 2 percent solution should not be used to treat infants and children with teething pain. We are requiring a new Boxed Warning, FDA’s strongest warning, to be added to the drug label to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.

Health care professionals should not prescribe or recommend this product for teething pain. Parents and caregivers should follow the American Academy of Pediatrics’ recommendations:

• Use a teething ring chilled in the refrigerator (not frozen).
• Gently rub or massage the child’s gums with your finger to relieve the symptoms.

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. 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 heart problems. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.

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

FDA is also encouraging not to use topical medications for teething pain that are available OTC as some of them can be harmful. In 2011 FDA warned that using OTC benzocaine gels for teething or mouth pain can cause a rare but serious condition called methemoglobinemia. It is life-threatening and can result in death. FDA has continued to receive reports of methemoglobinemia in infants and children associated with OTC benzocaine gels and liquids.

Patients should be encouraged to read the updated label for all oral viscous lidocaine products. Please report adverse reactions to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. A link to the full communication detailing specific information for healthcare professionals, all required labeling changes, and the complete Data Summary can be found atwww.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us atdruginfo@fda.hhs.gov.

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