FDA cracks down on benzocaine for teething

The U.S. Food and Drug Administration is banning the marketing of products containing the pain reliever benzocaine to relieve teething pain in infants and children, and asking companies to stop selling these products for this use.

Last week the FDA announced it was cracking down on companies selling benzocaine-containing products for teething relief due to “serious safety concerns.”

“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 Dr. Scott Gottlieb in a news release. “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-thecounter products containing benzocaine for teething pain.”

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 under such brand names as Anbesol, Baby Orajel, Cepacol, and Chloraseptic, as well as store brands and generics.

The new announcement builds on the FDA’s previous warnings about the risks associated with benzocaine products for methemoglobinemia. This dangerous condition is the result of elevated levels of methemoglobin in the blood and it can lead to death. It causes the amount of oxygen carried through the blood to be greatly reduced. The FDA also outlined these safety concerns in letters that the agency sent to manufacturers of these products.

In addition to urging companies not to sell or market these products for teething, the FDA announced was requesting that companies add new warnings to all other benzocaine oral health products to describe these safety risks.

The FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information about the risk of methemoglobinemia in product labeling across this class of products. Manufacturers of approved, prescription local anesthetics will have 30 days to reply to the FDA’s letter regarding these new safety labeling changes.

For advice on treating teething pain, the FDA recommends parents and caregivers follow the American Academy of Pediatrics’ recommendations, which are to use a teething ring made of firm rubber (not frozen), or to gently rub or massage the child’s gums with a finger to relieve symptoms. The FDA also previously cautioned parents and caregivers to not give certain homeopathic teething tablets to children and to seek advice from their health care professional for safe alternatives.