Of particular concern is a rare but potentially life-threatening side effect benzocaine can have in babies and young children called methemoglobinemia, in which the amount of oxygen in a person's blood is reduced. If they do not comply, the FDA says it will "will initiate a regulatory action to remove these products from the market".
Many over the counter products designed for teething pain contain benzocaine, a chemical that may pose serious health risks for infants and children. The agency has been warning the public about the dangers of these products, but reports of illnesses and deaths over the past decade have continued.
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According to the FDA, there have been approximately 400 cases of benzocaine-associated methemoglobinemia, with 11 patients younger than 2 years of age. These include pale, gray- or blue-colored skin, lips and nail beds; shortness of breath; fatigue; headache; lightheadedness; and rapid heart rate.
The FDA has been warning parents about gum-numbing products for years, but chose to take this tougher stance because of continuing concerns about the health and safety risks posed by these products.
Inflammation from teething may also stimulate pain-causing nerves, so reducing inflammation may help relieve baby's pain.
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The headline was followed with, "Agency urges companies to discontinue teething products, include new warnings for other OTC benzocaine products and revise warnings for approved prescription local anesthetic drugs".
The FDA highlighted in a statement that products such as Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store-brand alternatives, have benzocaine as an active ingredient. "Teething rings are helpful, too, but they should be made of firm rubber".
If lidocaine is used, healthcare staff should be familiar with appropriate dosing, proper administration techniques, and safety monitoring; benzocaine sprays are not FDA-approved to numb mucous membranes of the mouth and throat or to suppress the gag reflex during medical procedures.
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This is not the first warning about benzocaine from the FDA.