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FDA Drug Safety Podcast: Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

FDA Drug Safety Podcast: Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On May 23, 2018, FDA warned that over-the-counter (or 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 life-threating condition, called methemoglobinemia, in which the amount of oxygen carried through the blood is greatly reduced.

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:

  1. Add a warning about methemoglobinemia;
  2. Add contraindications directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years; and
  3. Revise the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years.

Health care professionals should warn patients of the possibility of methemoglobinemia and advise them of the signs and symptoms when recommending or prescribing local anesthetic products. Some patients are at greater risk for complications related to methemoglobinemia: those with breathing problems, heart disease, and the elderly. Health care professionals using local anesthetics during medical procedures should take steps to minimize the risk for methemoglobinemia by monitoring patients for signs and symptoms suggestive of methemoglobinemia; using co-oximetry when possible; and having resuscitation equipment and medications readily available, including methylene blue. We have been monitoring the risk of methemoglobinemia with the use of OTC and prescription local anesthetics and previously communicated about this risk in 2014, 2011, and 2006. We estimate that more than 400 cases of benzocaine-associated methemoglobinemia have been reported to FDA or published in the medical literature since 1971.

Report side effects involving benzocaine or prescription local anesthetics to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing information for health care professionals, including a listing of these products and the Data Summary, can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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