The FDA warned that prescription oral viscous lidocaine 2 percent solution should not be used to treat infants and children with teething pain. The FDA is requiring a new Boxed Warning, the 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 for treating teething pain:
- 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 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, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children five months to three and a half years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions. In addition to the Boxed Warning, the FDA is requiring revisions to the Warnings and Dosage and Administration sections of the drug label to describe the risk of severe adverse events and to include additional instructions for dosing when the drug is prescribed for approved uses.
The FDA is also encouraging parents and caregivers not to use topical medications for teething pain that are available over the counter (OTC) because some of them can be harmful. The FDA previously communicated about safety concerns related to use of OTC topical benzocaine teething preparations. In 2011, the FDA warned that using OTC benzocaine gels for teething or mouth pain can cause a rare but serious condition called methemoglobinemia. This condition results in a large decrease in the amount of oxygen carried through the blood. It is life-threatening and can result in death. The FDA has continued to receive reports of methemoglobinemia in infants and children associated with OTC benzocaine gels and liquids since the 2011 warning was issued. OTC benzocaine gels and liquids are sold under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and various store brands.
See the FDA Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication