Consumers should stop using over-the-counter teething products that contain benzocaine because they pose a serious health threat to infants and young children, U.S. health officials warn.
Benzocaine can cause a serious health threat called methemoglobinemia, which greatly reduces the level of oxygen carried through the blood. The condition is potentially fatal, the U.S. Food and Drug Administration said in a news release.
Benzocaine is marketed as a way to ease the pain of a variety of oral health problems, including teething, sore throat, canker sores, and irritation of the mouth and gums.
Products containing benzocaine are sold as gels, sprays, ointments, solutions and lozenges under such over-the-counter brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricane, Orabase, Orajel and Topex, the FDA said. There are also store brands and generics containing the compound.
The FDA said parents and caregivers should stop using the products and companies should stop selling them. If the manufacturers don’t comply with the order, the agency said it would take the necessary steps to remove the products from the market.
“Given the accumulating evidence regarding benzocaine’s association with methemoglobinemia, we are taking necessary action to work with industry to discontinue the distribution and sale of over-the-counter benzocaine oral health products intended for teething pain,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
Signs and symptoms of methemoglobinemia may set in after using benzocaine for the first time, and could appear within minutes to 1 to 2 hours. Symptoms include pale, gray- or blue-colored skin, lips and nail beds; shortness of breath; fatigue; headache; lightheadedness; and rapid heart rate. If any of these symptoms occur, the child should receive immediate medical care, the FDA said.
And, as always, store all drug products where children can’t reach them, the agency said.
To treat teething pain, the FDA suggests following recommendations from the American Academy of Pediatrics. The recommendations include using a teething ring made of firm rubber (but not frozen), or to gently rub or massage the child’s gums with a finger.
Pain relievers and medications that are rubbed on the gums for teething don’t work because they wash out of a baby’s mouth within minutes and may present safety concerns, the FDA said.