MediMedia Managed Markets
Managed Care magazine
P&T Community, The Online Resource for P&T Decision Makers
Login / Register
Join Us  Facebook  Twitter  Linked In


News Categories




FDA Warns Against Use of Lidocaine Viscous for Teething Pain

Boxed warning to be added for products

Prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain, says the FDA — and it is requiring the addition of a boxed warning to the product’s prescribing information to drive home that point.

Topical pain relievers and medications rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes, the FDA said. 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.

A search of FDA’s Adverse Event Reporting System database and the medical literature through December 2013 identified 22 cases of toxicity with the use of prescription oral viscous lidocaine 2% solution in infants and young children 5 months to 3.5 years of age. Of those cases, six resulted in death, three were categorized as life-threatening, 11 required hospitalization, and two required medical intervention without hospitalization.

The root cause of the overdose in seven of the 22 cases was the administration technique by caregivers, who did not follow prescriber directions for application of the product or gave additional doses beyond what was prescribed. Accidental ingestion occurred in seven additional cases, and four cases involved overdose due to a prescribing error.

The drug has been prescribed for the treatment of mouth pain, including teething and stomatitis. In 2012, infants and children 2 years of age and younger accounted for approximately 4% of all patients who received dispensed prescriptions in the outpatient retail setting for oral viscous lidocaine solution.

Rather than prescribing or recommending this product or over-the-counter (OTC) topical medications for teething pain, health care professionals can advise parents and caregivers to follow the American Academy of Pediatrics’ recommendations for treating teething pain. These include using a teething ring chilled in the refrigerator (not frozen) and gently rubbing or massaging the child’s gums with a finger to relieve symptoms.

In 2011, the FDA warned that use of OTC benzocaine gels and liquids applied to the gums or mouth to reduce pain was associated with methemoglobinemia, mainly in children aged 2 years and younger.

Source: FDA; June 26, 2014.

More stories