Benzocaine products often used by parents to relieve teething pain in infants and young children. However, following several previous warnings, the FDA has now issued an official warning to consumers. The agency has warned that these products could pose “a serious risk” and could lead to a condition called methemoglobinemia. The condition causes the levels of oxygen in the blood to drop. Symptoms include increased heart rate and breathing difficulties, and in some cases can be fatal.
Benzocaine teething products that are aimed at young children are often sold as gels, sprays, lozenges and solutions and come in a range of brand names. These include Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex; as well as other generic and own brand versions. Despite the fact that they are commonly used, most experts have agreed that they are not that effective in relieving pain and usually recommend alternatives like teething rings.
As a result of the recent warnings, the FDA has confirmed that it will be taking action to ensure the public know the risks. Benzocaine products aimed at children and infants will no longer be allowed to be sold over the counter, and letters will be sent to manufacturers to ask them to stop selling them. If they refuse, the FDA will take regulatory action. Products that are prescribed to children by doctors will also be required to carry new warnings on the packaging about the potential risks. Those that are marketing towards adults will still be allowed to be sold, but will need updated information on the packaging.
Dr. Lisa Thebner, a New York-based pediatrician, said: “It often has the word ‘baby’ in the title, so parents will naturally reach for the product. I will often address it when they ask, or I’ll try to address it during the well-baby checkups. I have, for a while, cautioned against topical gels because of the danger, and babies are in the population at the highest risk for harm, and if you look at the risk versus benefit, it’s not even all that helpful. Rubbing their gum or giving them something hard, like a teething ring, it will be a much bigger help.”
FDA Commissioner Dr. Scott Gottlieb said in a statement: “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. The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit.”