FDA Drug Safety Communication on Benzocaine

PUBLISHED: May 23, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office, Pharmacy

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. The FDA is 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 methemoglobinemia which can be life-threatening and result in death.

Due to the significant safety risk of methemoglobinemia, the FDA has 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, the FDA will take action to remove these products from the market.

FDA has 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.

The FDA will continue to monitor the safety and effectiveness of OTC benzocaine products and intend to take additional actions in the future as needed. In addition to their recent actions regarding OTC benzocaine products, FDA are also requiring a standardized methemoglobinemia warning to be included in the prescribing information of all prescription local anesthetics.

For more information, follow the link below.

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