The FDA is warning consumers that over-the-counter (OTC) teething products that contain Benzocaine pose “a serious risk to infants and children.” The agency announced that those products containing that pain reliever should no longer be marketed, and is asking companies to stop selling these products. If the companies do not comply, the FDA will initiate a regulatory action to remove those products from the market. The FDA is also asking that companies add warnings to all other benzocaine oral health products to describe some serious health risks.
FDA Commissioner Scott Gottlieb said, “The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit. 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 marketed as a pain reliever to help with conditions such as teething, sore throat, canker sores, and mouth and gum irritation. 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 issued a Drug Safety Communication last week, in which the agency builds on previous warnings. The product can cause a “rare but serious and potentially fatal adverse effect” called methemoglobinemia, which can be life-threatening. Benzocaine can cause this condition, which reduces the amount of oxygen carried through the blood. The FDA wants companies to stop marketing products containing benzocaine to children and infants under the age of 2.
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research 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. As part of the action, the agency is also requiring that prescription local anesthetics add updated warnings about their risk of this condition.”
The agency recommends that all consumers look at the Drug Facts Label on products when buying over the counter oral health drug products to see if benzocaine is listed. If it is, and the consumer chooses to use it, they should look for symptoms of methemoglobinemia.
The symptoms of this condition can appear after one use. They include pale, gray or blue-colors skin, lips and nail beds; shortness of breath; fatigue; headache; lightheadedness; and rapid heart rate. Anyone experiencing these conditions should seek medical attention immediately.
