The U.S. Food and Drug Administration is warning consumers that over-the-counter teething products containing benzocaine pose a serious risk to infants and children.
The agency says these products should no longer be marketed and is asking companies to stop selling these products for such use. If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market.
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 FDA warns of risks associated with benzocaine products for methemoglobinemia, a dangerous condition from elevated levels of methemoglobin in the blood which can lead to death. It causes the amount of oxygen carried through the blood to be greatly reduced.
The agency is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks and also 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.
For advice on treating teething pain, the FDA recommends parents and caregivers follow the American Academy of Pediatrics' (AAP) 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 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 health care professional for safe alternatives.
When buying OTC oral health drug products, consumers should refer to the OTC Drug Facts Label to see if benzocaine is an active ingredient and, if using these products, look for signs and symptoms of methemoglobinemia. Signs and symptoms may occur after using benzocaine for the first time, or after prior uses and may appear within minutes to 1 to 2 hours after using benzocaine. These 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 after using benzocaine, the person should receive medical attention immediately. All drug products, including local anesthetics, should be stored out of reach of children.