The agency also said adults and children 2 and older should use benzocaine oral drug products only if they contain specific warnings on the drug label.
"These products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething," the FDA said.
Used as a local anesthetic, benzocaine can cause methemoglobinemia, which can be life-threatening.
The FDA also announced it sent letters to manufacturers of these products, urging them to stop marketing the OTC oral drug products for treating teething in infants and children younger than age 2.
"If companies do not comply, we will take action to remove these products from the market," the agency said.
The FDA urged these manufacturers to make the following label changes for their products for use in children age 2 and older:
"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," said FDA Commissioner Scott Gottlieb, M.D., in a news release.
When recommending or prescribing local anesthetic products, the FDA advises health care professionals to warn patients about the potential risk of methemoglobinemia, and its signs and symptoms.
The agency said patients at greater risk for complications related to methemoglobinemia include those with breathing problems such as asthma, bronchitis or emphysema; heart disease; or those who are elderly.
Additionally, health care professionals using local anesthetics during medical procedures should take steps to minimize the risk for methemoglobinemia, the FDA said.
"These include monitoring patients for signs and symptoms suggestive of methemoglobinemia; using co-oximetry when possible; and having resuscitation equipment and medications readily available, including methylene blue," the agency's drug safety warning said.
Benzocaine is a local anesthetic contained in some OTC products for the temporary relief of pain due to minor irritation, soreness or injury of the mouth and throat.
The FDA said benzocaine products are marketed as gels, sprays, ointments, solutions and lozenges under brand names such as Anbesol, Orabase, Orajel, Baby Orajel, Hurricaine and Topex, as well as store brands and generics.
Prescription local anesthetics include articaine, bupivacaine, chloroprocaine, lidocaine, mepivacaine, prilocaine, ropivacaine and tetracaine.
The FDA recommends that parents and caregivers follow the American Academy of Pediatrics' recommendations to assuage teething pain. These recommendations include
In January 2017, the FDA cautioned parents and caregivers against giving children specific homeopathic teething tablets because the drugs contained inconsistent amounts of belladonna, a toxic substance. These products included Standard Homeopathic Co.'s Hyland's brand homeopathic teething products.
The FDA said it's closely monitored the risk of OTC and prescription local anesthetics, and issued related warnings in 2014, 2011 and 2006.
"We estimate that more than 400 cases of benzocaine-associated methemoglobinemia have been reported to the FDA or published in the medical literature since 1971," the agency's drug safety warning said. "There are likely additional cases about which we are unaware."
As part of its monitoring of this safety risk, the FDA said it recently evaluated 119 cases of benzocaine-associated methemoglobinemia that were reported to the agency and identified in medical literature between February 2009 and October 2017.
"We have continued to receive cases even after our 2014 communication," the agency said. "Most of the 119 cases were serious and required treatment."
Furthermore, the FDA said 22 of these cases occurred in patients younger than age 18, and 11 were in children younger than age 2. Four of the 119 patients died, including one infant.
"We also conducted a study comparing the relative ability of the two local anesthetics benzocaine and lidocaine to make methemoglobin," the FDA's drug safety warning said. "The study showed that benzocaine generated much more methemoglobin than lidocaine in a red blood cell model."
The FDA concluded its drug safety communication by urging health care professionals and consumers to report adverse reactions involving benzocaine or other medicines to the FDA's MedWatch program.
The agency said it will continue to monitor the safety of benzocaine products and take additional actions as appropriate.
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