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Over-the-counter (OTC) benzocaine products can cause methemoglobinemia. Methemoglobinemia is a rare condition that reduces the amount of oxygen carried in the blood. The most serious cases can result in death. Symptoms of methemoglobinemia include confusion, discolored lips, nail beds, or skin, fatigue, headache, lightheadedness, rapid heart rate, or shortness of breath. Symptoms usually occur within minutes to 2 hours after application, and may occur after 1 or more uses. If any of these symptoms occur after using benzocaine, stop use and seek medical attention.
Over-the-counter benzocaine-containing products include gels, lozenges, ointments, solutions, and sprays. Some branded products include Anbesol, Baby Orajel, Hurricaine, Orabase, Orjel, and Topex. Infants and children younger than 2 years old should not use these products. FDA is recommending labeling changes to benzocaine products to include a standardized methemoglobinemia warning and contraindications for use in teething infants and children younger than 2 year old. Any benzocaine products marketed to these patient populations will be removed from the market by FDA. A standardized methemoglobinemia warning will also be added to prescription local anesthetics. FDA will continue to evaluate the risk of methemoglobinemia associated with benzocaine and provide updated information as necessary.
Consumers should follow labeled recommendations for use of benzocaine products, using the smallest amount possible and not exceeding 4 applications per day. Topical pain relievers are not useful in teething, as the product washes away within minutes. The American Academy of Pediatrics recommends giving children a chilled teething ring as well as softly rubbing or massaging the child’s gums for teething pain relief.
Adults and children 2 years of age and older should only use topical benzocaine products if the labeling contains a warning regarding the risk of methemoglobinemia.
The American Dental Association has recommendations for the treatment of mouth sores in adults that do not include the use of topical benzocaine products.
FDA recommends healthcare professionals familiarize themselves with the signs and symptoms of methemoglobinemia. When recommending benzocaine products, advise patients to monitor for signs and symptoms of methemoglobinemia. Elderly patients, patients with underlying breathing problems or heart disease, and patients who smoke are at greater risk for methemoglobinemia-related complications. Report any benzocaine-related side effects to the FDA MedWatch program at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.
Additional information is available at the following links:
- Medwatch Alert (May 23, 2018)
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608612.htm - Drug Safety Communication (May 23, 2018)
www.fda.gov/Drugs/DrugSafety/ucm608265.htm - FDA News Release(September 30, 2016)
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm - MedWatch Alert (April 7, 2011)
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm250264.htm - MedWatch Alert (February 13, 2006)
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150501.htm - Drug Safety Communication (Benzocaine Liquids and Gels)
www.fda.gov/Drugs/DrugSafety/ucm250024.htm - Drug Safety Communication (Benzocaine Sprays)
www.fda.gov/Drugs/DrugSafety/ucm250040.htm