FDA Warns of Health Threat from Using Benzocaine

Could your baby’s teething gel be dangerous? Could using benzocaine spray or lozenges for a sore throat lead to a potentially fatal condition? Maybe, according to a new safety announcement from the U.S. Food and Drug Administration (FDA) released late last week.

Commonly found in over-the-counter products for the relief of mouth and teething pain, as well as many other pain and itch-relief products, benzocaine has been widely used for over a hundred years as a local anesthetic. Many popular teething gels and liquids, as well as products sold for canker sore and adult tooth pain relief, contain benzocaine. But the FDA is warning consumers and healthcare professionals to be cautious about the use of any oral benzocaine product because it can cause a rare condition that reduces the amount of oxygen carried through the blood stream which can be fatal, and can occur even if you’ve used benzocaine without any side effects in the past.

According to the FDA:

Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5%. The cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. People who develop methemoglobinemia may experience pale, gray or blue colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and rapid heart rate. In some cases, symptoms of methemoglobinemia may not always be evident or attributed to the condition. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. If you or your child has any of these symptoms after taking benzocaine, seek medical attention immediately.

The FDA is now recommending benzocaine-containing products should not be used on children less than two years of age, except under the advice and supervision of the child’s doctor or healthcare professional. Adults who use benzocaine products should talk with their healthcare provider before using and follow all label directions and of course, should always keep these products out of the reach of children.

For more information, read the FDA’s benzocaine safety announcement and talk with your healthcare provider if you have concerns about using benzocaine products.

About the Author

Tamara Walker, R.N., aka “MomRN”, is the mom of two teenagers, a registered nurse, a child safety expert and instructor, and host of the “Ask MomRN Show”. Her passions are to help parents as they navigate the journey through parenthood and to protect children of all ages. Her websites are http://www.MomRN.com and http://www.blogtalkradio.com/FlyLady. MomRN has been a member of the PedSafe Expert team


5 Responses to “FDA Warns of Health Threat from Using Benzocaine”

  1. I’m so glad my kids aren’t teething but this is good to know because my oldest is about to lose teeth and I just figured if he had a toothache I’d give him this stuff. Now I won’t!

    • Stefanie Zucker sazucker says:

      Honestly I’m embarrassed to admit it but I’ve used “Baby Anbesol” myself for tooth-aches, the occasional canker-sore, etc. It works quickly and I’ve never had a problem with it (although now I’d probably think twice about using it). I wonder what the drug companies will come up with next to replace it.

  2. Julie and Stefanie, I was surprised to learn of this and felt it was important to share, since so many of us use products with benzocaine in them, whether for teething kids, tooth pain, canker sores or sore throats. Time to look for alternatives. Stefanie, I would bet any parent who has baby teething gel has used it for their own pain as well. 🙂

  3. Thank you for sharing. Last night I called the triage nurse and they since the warning on the box said under 4 months talk to doc. They say to use as last resort but didn’t say why. I am sharing this info with all mom i know.


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