[Posted 06/26/2014]

AUDIENCE: Consumer, Pediatrics, Family Practice

ISSUE: FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (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.

Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the babys 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.

BACKGROUND: 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 who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions.See further details in the FDA Drug Safety Communication.

RECOMMENDATION: 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 childs gums with your finger to relieve the symptoms.

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. FDA recommends following the American Academy of Pediatrics recommendations to help lessen teething pain.

For additional information for health professionals and patients, including the full data summary, see the FDA Drug Safety Communication.

[06/26/2014 - Drug Safety Communication - FDA] [06/26/2014 - Consumer Update - FDA]