The FDA issued a warning today that that over-the-counter teething products containing benzocaine pose a serious risk to teething infants and children, and said it is taking steps to stop the sale of such products.
Benzocaine is the active ingredient in several OTC oral health care gels, lonzenges, ointments, solutions and sprays such as Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel, Topex, as well as store brand and generic versions of these same products, a press release stated. These products wash out of a baby’s mouth within minutes and hence, are not useful for treating sore gums due caused by teething, according to the FDA.
The agency said signs and symptoms of methemoglobinemia include fatigue; headache; lightheadedness; pale, gray- or blue-colored skin, lips and nail beds; rapid heart rate; and shortness of breath. These adverse events may occur after the first use of benzocaine or after previous uses and can begin within minutes to 1 to 2 hours after using benzocaine and require immediate medical attention.
Though the products are primarily used by teething infants and children, the FDA also indicated health care providers frequently utilize sprays with benzocaine in adults to numb the mucous membranes of the mouth and throat or to suppress the gag reflex during medical and surgical procedures, such as transesophageal echocardiograms, endoscopy, intubation and feeding tubes.
“Because of the lack of efficacy for teething and the serious safety concerns we’ve seen with OTC 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,” Scott Gottlieb, MD, FDA Commissioner, said in the release.
“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 OTC products containing benzocaine for teething pain. We will also continue working with Congress to modernize our OTC drug monograph regulatory framework as part of our mission to protect and promote public health,” he continued.
“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 OTC 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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release.
“As part of the action, the agency is also requiring that prescription local anesthetics add updated warnings about their risk of this condition,” she added.
The FDA issued a warning today that that over-the-counter teething products containing benzocaine pose a serious risk to teething infants and children, and said it is taking steps to have these companies stop selling such products for this purpose.
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Manufacturers of approved, prescription local anesthetics will have 30 days to reply to the agency’s letter regarding these new Safety Labeling Changes or face FDA regulatory action, the release said.
The FDA recommended that health care providers, parents and caregivers follow the AAP recommendations on teething, which include utilizing an unfrozen teething ring consisting of firm rubber, or to use the finger to gently massage or rub the child’s gums.
Gottlieb and Woodcock are employed by the FDA.