FDA takes action against use of OTC benzocaine teething products
WASHINGTON — The U.S. Food and Drug Administration is warning consumers that OTC teething products containing benzocaine pose a serious risk to infants and children and is asking that companies stop selling these products for such use.
If companies do not comply, the FDA stated that it will initiate regulatory action to remove these products from the market. The agency also is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.
Benzocaine is marketed to help relieve pain from a variety of conditions such as teething, sore throat, canker sores and irritation of the mouth and gums. 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.
In a Drug Safety Communication issued on Wednesday, the agency builds on its previous warnings about risks associated with benzocaine products for methemoglobinemia. This dangerous condition is the result of elevated levels of methemoglobin in the blood and it can lead to death. It causes the amount of oxygen carried through the blood to be greatly reduced. The FDA also outlined these safety concerns in letters that the agency sent to manufacturers of these products. The agency made specific recommendations to manufacturers in order to protect patients and make sure the most up-to-date drug safety information will appear on drug labels.
“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 over-the-counter 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,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “As part of the action, the agency is also requiring that prescription local anesthetics add updated warnings about their risk of this condition.”
The FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information about the risk of methemoglobinemia in product labeling across this class of products. Manufacturers of approved, prescription local anesthetics will have 30 days to reply to the FDA’s letter regarding these new Safety Labeling Changes.
If companies do not comply, the FDA stated that it will initiate regulatory action to remove these products from the market. The agency also is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.
Benzocaine is marketed to help relieve pain from a variety of conditions such as teething, sore throat, canker sores and irritation of the mouth and gums. 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.
In a Drug Safety Communication issued on Wednesday, the agency builds on its previous warnings about risks associated with benzocaine products for methemoglobinemia. This dangerous condition is the result of elevated levels of methemoglobin in the blood and it can lead to death. It causes the amount of oxygen carried through the blood to be greatly reduced. The FDA also outlined these safety concerns in letters that the agency sent to manufacturers of these products. The agency made specific recommendations to manufacturers in order to protect patients and make sure the most up-to-date drug safety information will appear on drug labels.
“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 over-the-counter 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,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “As part of the action, the agency is also requiring that prescription local anesthetics add updated warnings about their risk of this condition.”
The FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information about the risk of methemoglobinemia in product labeling across this class of products. Manufacturers of approved, prescription local anesthetics will have 30 days to reply to the FDA’s letter regarding these new Safety Labeling Changes.