FDA is asking manufacturers to immediately stop selling OTC products containing the pain reliever benzocaine (such as Orajel) for teething in infants or children.
The agency found that teething products containing benzocaine pose a “serious risk to infants and children,” FDA said in a statement. If companies do not comply, FDA will initiate a regulatory action to remove the products from the market.
Pharma makers must also add new warnings to all other benzocaine oral health products to describe certain serious risks. FDA is also requiring that prescription local anesthetics add updated warnings about their risk of this condition.
“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,” said FDA Commissioner Scott Gottlieb, MD, in the statement.
Benzocaine is marketed to help relieve pain from a variety of conditions such as teething, sore throat, canker sores and irritation of the mouth and gums. The products are sold as gels, sprays, ointments, solutions and lozenges under the OTC brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store brands and generics.
The benzocaine-containing oral health products can cause methemoglobinemia, a dangerous condition that can lead to death. “It causes the amount of oxygen carried through the blood to be greatly reduced,” FDA said.
“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, and add warning information about methemoglobinemia and a contraindication against use for teething pain and against use in children under two years of age to the remaining oral health care drug products containing benzocaine,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research.