US FDA takes action against OTC benzocaine products for teething infants

24 May 2018 --- The US Food and Drug Administration (FDA) has warned that over-the-counter (OTC) teething products containing benzocaine may pose a serious risk to infants and children. The popular numbing agent can offer temporary relief to sore gums in teething infants; however, the FDA advises that companies stop marketing and selling these products for use. The agency is also raising awareness of the risks that, they state, come with other oral health benzocaine products. 

“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,” says FDA Commissioner Scott Gottlieb, M.D.

“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 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 often sold as gels, sprays, ointments, solutions and lozenges under a range of OTC brands, as well as store brands and generics. 

In a Drug Safety Communication issued recently, the agency builds on its previous warnings about risks associated with benzocaine products for the condition methemoglobinemia. This condition is the result of elevated levels of methemoglobin in the blood and it can be fatal. The FDA outlined these safety concerns in letters to manufactures and made specific recommendations to manufacturers in attempts to protect patients and make sure the most up-to-date drug safety information would appear on drug labels.

“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,” says Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

For advice on treating teething pain, the FDA is recommending parents and caregivers follow the American Academy of Pediatrics' (AAP) recommendations, which are to use a teething ring made of firm rubber, or to gently rub or massage the child's gums with a finger to relieve symptoms. The AAP notes that pain relievers and medications that are rubbed on the gums for teething are not useful because they wash out of the baby's mouth within minutes and may present safety concerns. The FDA also previously cautioned parents and caregivers to not give certain homeopathic teething tablets to children and to seek advice from their healthcare professional for safe alternatives.

The FDA further suggest that when buying OTC oral health drug products, consumers should refer to the OTC Drug Facts Label to see if benzocaine is an active ingredient. If consumers go on to use these products, they should look for signs and symptoms of methemoglobinemia.