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FDA warns consumers against using benzocaine products

May 24, 2018

By Jennifer Garvin

Silver Spring, Md. — The U.S. Food and Drug Administration issued a safety announcement May 23 warning consumers not to use teething products containing benzocaine in infants and children younger than 2 years.

The announcement updates previous FDA Drug Safety Communications reporting benzocaine’s association with methemoglobinemia, a disorder in which the amount of oxygen carried through the blood stream is greatly reduced.

The FDA warns that benzocaine-containing products not be used to treat infants and children younger than 2 years because the agency has found the products carry serious risks and provide little to no benefit for treating sore gums in infants due to teething. FDA further advises that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label because the local anesthetic benzocaine can cause the life-threatening condition, methemoglobinemia. 

FDA is urging companies to stop marketing these products to treat teething in infants and children younger than 2 years. If the companies do not comply, action to remove these products from the market may be taken. FDA is also urging manufacturers to add warnings about methemoglobinemia and contraindication language to labels directing parents and caregivers not to use these products for teething.

“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 prepared remarks on May 23.

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.

Commissioner Gottlieb added that the FDA will also continue working with Congress to modernize its OTC drug monograph as part of its “mission to protect and promote public health.” The ADA is on the record with supporting both House and Senate legislation calling for modernizing the monograph.

The FDA estimated that more than 400 cases of benzocaine-associated methemoglobinemia have been reported to FDA since 1971. From 2009-17, the FDA evaluated 119 such cases reported to the agency’s MedWatch Safety Information and Adverse Event Reporting Program. Of those cases, 22 occurred in patients younger than 18 years and 11 were in children under 2.

The agency said health care professionals should warn patients of the possibility of methemoglobinemia and advised providers using local anesthetics to monitor patients for signs and symptoms and to have resuscitation equipment and medications readily available, including methylene blue.

Dentists can refer their patients to MouthHealthy.org for more information on safety concerns surrounding over-the-counter benzocaine gels and liquids.

The FDA encourages health care professionals and patients to report adverse events or side effects to the MedWatch program by submitting a form on its website at www.fda.gov/MedWatch/report.htm.