New Drug Safety Communication on benzocaine - Drug Information Update

The U.S. Food and Drug Administration (FDA) is warning that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. We are also warning 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. These products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething. Benzocaine, a local anesthetic, 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, we have urged manufacturers that they should stop marketing OTC oral drug products for treating teething in infants and children younger than 2 years. If companies do not comply, we will take action to remove these products from the market. We have also urged manufacturers of OTC oral drug products containing benzocaine for adults and children 2 years and older to make the following changes to the labels of their products: Adding a warning about methemoglobinemia; Adding contraindications, FDA’s strongest warnings, directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years; and Revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years. We continue to monitor the safety and effectiveness of OTC benzocaine products and intend to take additional actions in the future as needed. We will notify the public about any updates. In addition to our recent actions regarding OTC benzocaine products, we are also requiring a standardized methemoglobinemia warning to be included in the prescribing information of all prescription local anesthetics. For more information, please visit: Benzocaine.