FDA Warning On Benzocaine Ointments

Benzocaine  Alert

The FDA has recently published a recommendation and warning against the use of Benzocaine topical anesthetic ointments that could result in a rare condition called methemoglobinemia.  Since their original report in 2006 there have been 29 cases of methemoglobinemia reported and of those, 19 were children, 15 were under two years old.

Benzocaine is a local anesthetic and can be found in such over-the-counter (OTC) products as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase.

Mothers with babies that are teething may resort to some of these gels or ointments in an effort to soothe their babies gums, but this can result in the rare but almost always fatal condition.

The FDA rec­ommends that parents and care­givers not use benzocaine prod­ucts for children younger than 2 years, except under the advice and supervision of a health care professional.

The symptoms can be confused with other problems, here is a list of the signs of methemoglobinemia:

• pale, gray, or blue-colored skin, lips and nail beds

• shortness of breath

• fatigue

• confusion

• headache

• light-headedness
• rapid heart rate

If your child has any of these symptoms after using benzocaine discontinue using it and call 911.

As an alternative to ointments, you can use a chilled teething ring or gently rub your child’s gums with a clean finger.

Children present a higher risk, but adults can be affected also.

For the original article by the FDA please see the link below:

http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM306069.pdf

FDA advises consumers to:

• store any products containing ben­zocaine out of the reach of children.

• use benzocaine gels and liquids sparingly and only when needed. Do not use them more than 4 times a day.

• read the label to see if benzocaine is an active ingredient when buying OTC products. Labels on OTC prod­ucts containing benzocaine are not currently required to carry warn­ings about the risk of methemoglo­binemia. If you have any concerns, talk to your health care professional before using them.

Carlos Boudet, DDS DICOI
1840 Forest Hill Blvd Suite 204
West Palm Beach, Florida. 33406
Website: http://www.boudetdds.com
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