FDA Petitioned to Remove Over-the-Counter Teething Gels

FDA Petitioned to Remove Over-the-Counter Teething GelsJuly 31, 2014 — Public Citizen, a consumer advocacy group, has filed a petition (PDF) asking the U.S. Food and Drug Administration (FDA) to remove over-the-counter teething gels from the market due to a rare but potentially deadly side effect known as methemoglobinemia.

The group also wanted the FDA to issue warnings about over-the-counter products containing benzocaine that are used by adults.

The problem is that benzocaine, a topical anesthetic, has never been tested in clinical trials as a teething gel for infants. The FDA has never approved the products for this purpose.

In May 2012, the FDA issued a warning, Benzocaine and Babies: Not a Good Mix, for products like Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. Since 2006, the FDA has received 29 reports of the side effect. They recommend against using the products in children under two years old. In May, the FDA also recommended against using lidocaine gel.

Public Citizen said these actions do not go far enough. The organization is also concerned that a warning label is not sufficient and the only solution is removing the products from the market.

In some cases, symptoms occur hours after the gel is applied. Some teething gels are advertised for nighttime use, such as Orajel Medicated Teething Nighttime Gel, making it even more likely that the family will be asleep if a side effect occurs. Even more troubling, the nighttime formula contains an even higher concentration of benzocaine — 10.5% vs. 7.5%.

Safer alternatives to benzocaine recommended by the American Academy of Pediatrics include the use of cold items, such as refrigerated teething rings, wet washcloths, and bananas. Gently massaging the infants gums with your fingers can also help.

Symptoms of Methemoglobinemia

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

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