The press release states that if companies do not comply, the FDA will initiate a regulatory action to remove these products from the market. The agency has been warning about the product for a decade but said reports of illnesses and deaths have continued. This unsafe condition is the result of elevated levels of methemoglobin in the blood and it can lead to death. At the time, it estimated that there have been more than 400 cases of benzocaine-associated methemoglobinemia reported to the FDA or published in medical literature since 1971. Signs of methemoglobinemia include shortness of breath, fatigue, and pale, gray, or blue-colored skin, lips and nail beds. Now it says there's little evidence these products actually work. Also, they are not of that much effect, because they can be washed out of the mouth very quickly.
Do Teething Babies Need Medicine on Their Gums?
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Benzocaine is found in many popular teething products sold as gels, sprays, ointments, solutions and lozenges.
"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", said Dr. Lisa Thebner, a New York-based pediatrician. "No" and told parents to instead gently rub a child's gums with a finder or use a firm rubber teething ring.
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 advised that consumers should refer to the OTC Drug Facts Label to check if the oral health drug product they are buying uses benzocaine as an active ingredient.