On Wednesday, June 23, 2018, the U.S. Food and Drug Administration (FDA) issued a warning that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years old. This is significant because many of the medications are marketed specifically for teething infants and toddlers.
Among the teething-relief products containing benzocaine are Orajel Medicated Teething Gel; Nighttime Orajel Medicated Teething Gel; Orajel Medicated Teething Swabs. Additionally, several adult-targeted tooth pain products, including Orajel, Ambesol and DenTek, contain benzocaine.
The FDA stated that the local anesthetic benzocaine can cause methemoglobinemia, a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition can result in death.
Due to the significant safety risk of methemoglobinemia, the FDA has urged manufacturers that they should stop marketing OTC oral drug products containing benzocaine for treating teething in infants and children younger than 2 years old. In a statement on its website, the FDA added, “If companies do not comply, we will take action to remove these products from the market.”
The organization has also called on manufacturers of benzocaine oral drug products to add the warnings to the medication’s label:
- A warning about methemoglobinemia;
- Contraindications, FDA’s strongest warnings, directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years;
- And revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years.
In addition to the FDA’s actions regarding OTC benzocaine products, it has also required a standardized methemoglobinemia warning to be included in all prescription local anesthetics.