FDA Issues Warning Update on Serious Risks Associated With OTC Benzocaine-Containing Oral Products – APhA submits compounding comments to FDA. – (866) 348-2889.
OTC oral drug products containing benzocaine should not be used to treat infants and children younger than two years, warns FDA. The agency also advises that benzocaine oral drug products should only be used in adults and children two years and older, if they contain certain warnings on the drug label. According to FDA’s safety announcement, these products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething. Benzocaine can cause a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, can be life-threatening and result in death.
Due to the significant safety risk of methemoglobinemia, FDA has urged manufacturers that they should stop marketing OTC oral drug products for treating teething in infants and children younger than two years. FDA has also urged manufacturers of OTC oral drug products containing benzocaine for adults and children two years and older to make the following changes to the labels of their products: