The US Food and Drug Administration (FDA) announced today that over-the-counter (OTC) teething products containing benzocaine pose a serious risk to infants and children.
Currently, benzocaine is marketed to help relieve pain from a variety of conditions, and 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 agency said that products containing benzocaine for the temporary relief of sore gums due to teething should no longer be marketed and is asking that companies stop selling them for this purpose.
“If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market,” the FDA said in a news release.
According to a recently released Drug Safety Communication, the FDA says that these products are associated with an increased risk for methemoglobinemia—a dangerous condition that occurs when there are elevated levels of methemoglobin in the blood. The condition causes the amount of oxygen carried through the blood to increase, and can lead to death.
The FDA announced that they have outlined safety concerns in letters that were sent to manufacturers of these products. The agency has made recommendations to the manufacturers in an effort to protect patients and ensure that the drug labels are up-to-date on safety information. The labels must now standardize warning information about the risk of methemoglobinemia in product labeling across this class of products. The companies have 30 days to reply to the FDA’s letter regarding these updates.
“The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit,” Scott Gottlieb, MD, commissioner of the FDA, said in a press 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.
Additionally, Dr Gottlieb warned against the use of these products and outlined a plan for legislation to increase regulatory standards for OTC 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,” he said. “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.”
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