FDA Warns Parents About Teething Medicine Risks

Federal health officials have issued a warning to parents about the dangers of teething remedies containing a popular numbing ingredient. Products containing the drug benzocaine have been linked to rare but deadly side effects in children. The Food and Drug Administration asked manufacturers to stop selling benzocaine products intended for babies and toddlers.

Benzocaine is used in popular over-the-counter products under brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store brands and generics. They are generally used for teething pain, toothaches, and cold sores. Benzocaine products can be found as gels, sprays, ointments, solutions and lozenges.

Benzocaine can cause a rare blood condition called methemoglobinemia, where the oxygen level in blood dips dangerously low. Symptoms include shortness of breath, lightheadedness, difficulty breathing, headache, pale skin and nails that are blue or gray. It can be fatal. Babies who experience these symptoms should get medical attention immediately. In 2011, it was estimated that there had been more than 400 cases of benzocaine-associated methemoglobinemia since 1971.

The American Academy of Pediatrics does not recommend teething creams for infants because there is little evidence they actually work. Instead, parents should give babies teething rings or massage their gums to relieve pain. Parents are cautioned to avoid frozen teething toys, as they can injure the mouth and cause more pain.

FDA Commissioner Dr. Scott Gottlieb said in a statement, “Because of the lack of efficacy for teething and the serious safety concerns we’ve seen with over-the-counter benzocaine oral health products, the FDA is taking steps to stop use of these products in young children and raise awareness of the risks associated with other uses of benzocaine oral health products.”

The FDA has sent letters to manufacturers asking them to stop selling teething products containing benzocaine. At least one major manufacturer, Church and Dwight Co. Inc., has said it would pull its products intended for infants from the shelves. The company is discontinuing its four Orajel teething brands, including Baby Orajel and Orajel Medicated Teething Swabs.

The FDA said it will take legal action against companies that don’t voluntarily comply as soon as possible. Products for adults can remain on the market but the FDA wants the manufacturers to add new warnings about the risks. Church and Dwight has said that it will continue to sell its other Orajel products.