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Benzocaine and Babies: Not a Good Mix

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When a baby is teething, many a mom or dad reaches for a pain remedy containing benzocaine to help soothe sore gums.  Benzocaine is a local anesthetic and can be found in such over-the-counter (OTC) products as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase.

But the use of benzocaine gels and liquids for mouth and gum pain can lead to a rare but serious—and sometimes fatal—condition called methemoglobinemia, a disorder in which the amount of oxygen carried through the blood stream is greatly reduced.  In the most severe cases, says FDA pharmacist Mary Ghods, R.Ph., methemoglobinemia can result in death.

And children under 2 years old appear to be at particular risk.

Since the Food and Drug Administration (FDA) first warned about potential dangers in 2006, the agency has received 29 reports of benzocaine gel-related cases of methemoglobinemia.  Nineteen of those cases occurred in children, and 15 of the 19 cases occurred in children under 2 years of age, says FDA pharmacist Kellie Taylor, Pharm.D., MPH. 

The agency repeated the warning in April 2011 and remains particularly concerned about the use of OTC benzocaine products in children for relief of pain from teething, says Taylor. This concern is fueled by the serious potential outcomes and the difficulty parents may have recognizing the signs and symptoms of methemoglobinemia when using these products at home. These symptoms may not always be evident or attributed to the condition.

For these reasons, 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.

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Danger Signs

Symptoms of methemoglobinemia include:

  • pale, gray, or blue-colored skin, lips and nail beds
  • shortness of breath
  • fatigue
  • confusion
  • headache
  • light-headedness
  • rapid heart rate

“Symptoms can occur within minutes to hours after benzocaine use,” Ghods says. “They can occur after using the drug for the first time, as well as after several uses.”

If your child has any of these symptoms after using benzocaine, she adds, stop using the product and seek medical help immediately by calling 911.  

Methemoglobinemia caused by benzocaine may require treatment with medications and admission to a hospital. Serious cases should be treated right away. If left untreated or if treatment is delayed, methemoglobinemia may cause permanent injury to the brain and body tissues, and even death, from the insufficient amount of oxygen in the blood.

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Teething: What’s a Parent to Do?

As for the crying baby, what’s a mom or dad to do? The American Academy of Pediatrics offers some alternatives for treating teething pain:

  • Give the child a teething ring chilled in the refrigerator.
  • Gently rub or massage the child’s gums with your finger.

If these remedies don’t provide relief, contact your health care professional for advice on other treatments.

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Adults Can Be Affected Too

Benzocaine products—which are sold as gels, liquids, sprays and lozenges—are also widely used by adults.  Doctors and dentists often use sprays containing benzocaine to numb the mucous membranes of the mouth and throat during such procedures as transesophageal  echocardiograms, endoscopy, intubation, and feeding tube replacements. 

Even though children are more at risk, it’s still a good idea to talk to your health care professional about using benzocaine, especially if you have heart disease; are a smoker; or have breathing problems such as asthma, bronchitis or emphysema. These conditions put you at greater risk for complications relating to methemoglobinemia, says Taylor.

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.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Posted May 31, 2012

For more about food, medicine, cosmetic safety and other topics for your health, visit FDA.gov/ForConsumers.
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