FDA Warning Regarding Benzocaine Use and Rare, But Serious Condition

April 14, 2011 12:51 pm

Food and Drug Administration (FDA) has issued a warning to consumers and health care providers regarding the use of benzocaine and its association with a rare, but serious condition, methemoglobinemia. Methemoglobinemia results in the amount of oxygen carried through the blood stream being greatly reduced, and in the most severe cases, can result in death. Benzocaine gels and liquids are sold over-the-counter (OTC) under different brand names – such as Anbesol^®, Hurricaine^®, Orajel^®, Baby Orajel, Orabase^®, and store brands – and are used to relieve pain from a variety of conditions including teething, canker sores, and irritation of the mouth and gums. Benzocaine is also sold in other forms such as lozenges and spray solutions.

FDA notes that methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5%. Further, the cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. Symptoms include pale, gray or blue colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and rapid heart rate and usually appear within minutes to hours of applying benzocaine. Symptoms may occur with the first application of benzocaine or after additional use. FDA advises the following:

• Benzocaine products should not be used on children less than two (2) years of age, except under the advice and supervision of a health care professional.
• Treatments for teething pain as recommended by the American Academy of Pediatrics, including using chilled teething rings, and gently rubbing the teething child’s gums to relieve teething symptoms should be considered.
• Benzocaine products should be stored out of reach of children.
• Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label.
• If benzocaine products are used, patients and/or health care providers should watch for the signs and symptoms of methemoglobinemia noted above.
• If consumers or their children experience any of the symptoms noted above after taking benzocaine, they should seek medical attention immediately.

More information about the FDA warning regarding benzocaine gels and liquids is available in an FDA Drug Safety Communication. An FDA Drug Safety Communication about benzocaine sprays is also posted on the FDA Web site.