FDA Issues Warning On Benzocaine-Based Products

Posted Wednesday, August 10, 2011 --- 4:55 p.m.

From the Public Health Madison & Dane County:

- FDA Issues Warning on Benzocaine-based Products
- Warning focuses on Risk to Young Children

The Food and Drug Administration has just published a warning regarding the use of over the counter benzocaine-based products that are designed to reduce pain when applied to the mouth or gums with children less than two years of age, typically used when they are teething. Public Health Madison and Dane County is passing this information to the local media. Further information about this is available in the link provided below.

Benzocaine warning

The Food and Drug Administration (FDA) has published a drug safety communication on oral benzocaine products such as Orajel, Orabese, Anbesol and others used in infants for teething. Benzocaine is the main ingredient in these over-the-counter gels and liquids which are applied to the gums or mouth to reduce pain. The FDA has received reports of a rare but potentially life threatening condition known as methemoglobinemia caused by use of these products. The condition results in a great reduction of the amount of oxygen carried through the blood stream and, in most severe cases, can cause death. The FDA is recommending that benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a health care professional. For more information, go to http://www.fda.gov/Drugs/DrugSafety/ucm250024.htm.


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