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FDA: OTC Benzocaine Contraindicated for Teething

By Kelly Young

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM

The FDA is urging caregivers not to use over-the-counter topical benzocaine (e.g., Baby Orajel) to ease teething pain in children and not to use it for any reason in children under age 2 years, given its association with methemoglobinemia. 

Methemoglobinemia leads to a decrease in oxygen in the blood supply and can result in death. Signs of methemoglobinemia can arise within minutes or up to 2 hours of using benzocaine. More than 400 cases have been reported since 1971.

The agency is also sending warning letters to companies that sell such products and is requesting that oral benzocaine carry a warning label for its use among older children and adults.

The American Academy of Pediatrics offers tips for safely treating teething pain at the link below. They recommend rubbing a finger against infant's irritated gums or using a firm rubber teething ring.

FDA MedWatch safety alert (Free)

AAP teething pain guide (Free)

Background: Physician's First Watch coverage of methemoglobinemia and topical benzocaine (Free)

Benjamin Hidalgo-Matlock

Skin Care Physicians of Costa Rica

4000-1054

2101-9574

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