The Food and Drug Administration (FDA) has reissued a warning about the use of benzocaine gels or liquids torelieve teething pain for children under age 2.
Benzocaine is a local anesthetic and can be found in such over-the-counter products as Anbesol, Hurricaine,Orajel, Baby Orajel, and Orabase.
FDA is warning parents and caregivers that the use of benzocaine gels and liquids for mouth and gum pain canlead to a rare but serious—and sometimes fatal—condition called methemoglobinemia, a disorder in which theamount of oxygen carried through the blood stream is greatly reduced. Adults with heart disease or breathingproblems and smokers are also at greater risk for the disease.
According to the agency, since it first warned about potential dangers in 2006, FDA has received 29 reports ofbenzocaine gel-related cases of methemoglobinemia. Nineteen of those cases occurredin children, and 15 of the 19 cases occurred in children under 2 years of age, says FDA pharmacist Kellie Taylor, PharmD, MPH, in a news release. FDA remains particularly concerned about the use of these OTC benzocaine productsas parents may have difficulty recognizing the signs and symptoms of Methemoglobinemia.
According to the FDA’s warning, methemoglobinemia caused by benzocaine may require treatment with medications and admission to a hospital right away. If left untreated, or if treatment is delayed, FDA noted, methemoglobinemia may cause permanent injury to the brain and body tissues, and even death.
For moreinformation, visit fda.gov/ForConsumers/ConsumerUpdates/ucm306062.htm