FDA says stop using over-the-counter benzocaine products on teething infants

The U.S. Food and Drug Administration released a warning on May 23, 2018, that over-the-counter benzocaine teething products pose a serious safety risk to infants and lack benefit for teething children. (Photo: Rob Hainer/Getty Images/iStockphoto)

FDA says stop using over-the-counter on teething infants


Parents: Your kids don’t need topical soothing medicines for their teething gums, the U.S. Food and Drug Administration is saying.

In fact, Wednesday morning the FDA issued a warning against over-the-counter teething products containing benzocaine, saying they pose a “serious risk to infants and children” and lack benefit, as well.

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Benzocaine and the risk

Benzocaine is a “topical anesthetic” used to relieve pain in teething, sore throats, canker sores and mouth and gum irritation, according to the FDA and National Institutes of Health.

The agency says there is “accumulating evidence” that benzocaine is associated with methemoglobinemia, a dangerous blood condition that can lead to death.

Well-known benzocaine brands:

The medication comes in various forms, including “gels, sprays, ointments, solutions and lozenges,” according to the FDA. Popular brands include:

  • Anbesol
  • Baby Orajel
  • Cepacol
  • Chloraseptic
  • Hurricaine
  • Orabase
  • Orajel
  • Topex
  • Store brands and generics

FDA recommendations for infants:

The FDA and the American Academy of Pediatrics recommend a firm but not frozen rubber teething ring. Parents can also gently massage kids’ gums.

If your child has ingested products with benzocaine, look for symptoms of methemoglobinemia. Kids demonstrating any of the symptoms should seek medical attention.

Methemoglobinemia symptoms:

  • pale, gray- or blue-colored skinlips and nail beds
  • shortness of breath
  • fatigue
  • headache
  • lightheadedness
  • rapid heart rate

What the FDA is doing about it

The agency sent letters to multiple manufacturers producing such pain-relief products, asking them to no longer market them and cease selling them “for such use.”

“If companies do not comply,” the FDA said it will “initiate a regulatory action to remove these products from the market. “

Director Janet Woodcock said the FDA is working to “add warning information about methemoglobinemia and a contraindication against use for teething pain and against use in children under 2 years of age to the remaining oral health care drug products containing benzocaine.”

The FDA will also require “that prescription local anesthetics add updated warnings about their risk of this condition.”

Source: All The Moms


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