Lidocaine, viscous (Oral solution)
WARNING: Life-threatening and fatal events in infants and young children
- Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Xylocaine 2% Viscous Solution when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Xylocaine 2% Viscous Solution should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.
- To decrease the risk of serious adverse events with use of Xylocaine 2% Viscous Solution, instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the prescription bottle safely out of reach of children
- Drug Safety Communication on OTC benzocaine gels and liquids).
- Prescription viscous lidocaine solution is NOT approved by FDA to treat teething pain.
FDA and Industry Communications
Updated January 2018