Parents, your baby may be at risk if they're teething. The U.S. Food and Drug Administration is warning about over-the-counter teething products containing benzocaine like Anbesol and Orajel.

The products that provide temporary relief of sore gums due to teething should no longer be marketed and the FDA is asking companies to stop selling them. The agency is also asking companies to add new warnings to all other benzocaine oral health products to include certain serious risks.

“The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit,” said FDA Commissioner Scott Gottlieb, M.D. “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. In addition to our letters to companies who make these products, we urge parents, caregivers and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain. We will also continue working with Congress to modernize our over-the-counter drug monograph regulatory framework as part of our mission to protect and promote public health.”

Benzocaine is used to relieve teething pain, sore throat, canker sores and irritation of the mouth and gums and is sold in gels, sprays, ointments, solutions and lozenges under several brand names, store brands and generics.

Orajel and Baby Orajel

The Drug Safety Communication is also warnings about risks associated with benzocaine products for methemoglobinemia; elevated levels of methemoglobin in the blood that can lead to death. It causes the amount of oxygen carried through the blood to be greatly reduced.

“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, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Parents are being encouraged to use a firm rubber teething ring (not frozen), or gently rub or massage the child’s gums with a finger to relieve any pain. Pain relievers and medications rubbed on gums for teething are not useful. It washes out of the baby’s mouth within minutes and can have safety concerns.


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