FDA warns some teething medicines unsafe, wants them off shelves

Henrietta Brewer
May 25, 2018

Federal health officials in the US warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers.

"In addition, we also are revising the Drug Facts Label on all over-the-counter oral health care products that contain benzocaine with an intended use other than teething to emphasize that these products should not be used for teething pain or in children under 2 years of age", the statement said. The ultimate goal here is to discontinue these treatments' marketing altogether; if companies don't play ball, "the FDA will initiate a regulatory action to remove these products from the market". As such, the Agency is urging manufacturers to stop marketing OTC oral drug products containing benzocaine for teething to this patient population.

Using these products can lead to a serious and sometimes fatal condition where the oxygen-carrying capacity of red blood cells is greatly reduced.

The FDA recommends massaging your child's gums with your finger if your child is having teething pain. Symptoms include a gray or bluish appearance, especially in the lips and nail beds, as well as rapid breathing and an elevated heart rate.


Wednesday's action comes more than four years after the consumer advocacy group Public Citizen petitioned the FDA to stop sales of teething products.

Cold washcloth, spoon, or chilled teething ring can also soothe the baby's gums. Further, the academy has advised parents to avoid giving children frozen teething toys.

The issued warning referred to benzocaine teething products for not being able to demonstrate sufficient benefits. Signs and symptoms may occur after using benzocaine for the first time, or after prior uses and may appear within minutes to 1 to 2 hours after using benzocaine.

The FDA expects manufactures to voluntarily remove their products as soon as possible.


Some brands that have benzocaine includes brands like Baby Orajel, Anbesol and Topex.

If lidocaine is used, healthcare staff should be familiar with appropriate dosing, proper administration techniques, and safety monitoring; benzocaine sprays are not FDA-approved to numb mucous membranes of the mouth and throat or to suppress the gag reflex during medical procedures.

"Here you have a product that doesn't really help and can induce harm", says Meeks. Now, it wants teething products off the market, noting there is little evidence they actually work.


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