Teething Products Containing Benzocaine Not Safe For Kids: FDA

Over-the-counter teething pain relief products that contain benzocaine pose a serious risk to infants and children and often have no benefit, the FDA warned this week. The agency said products containing benzocaine for teething pain should no longer be marketed and is asking companies to stop selling them for that purpose.

In its warning, the FDA said that if companies do not comply, the agency will initiate a regulatory action to remove the products from the market. The FDA also asked companies to add new warning to all other benzocaine oral health products.

Benzocaine is marketed as a pain reliever for several conditions like sore throat, canker sores and teething and the products are sold as gels, sprays, ointments, solutions and lozenges. Some of the brand names the products are sold under include Anbesol, Baby Orajel and Cepacol.

According to the FDA, there are risks associated with benzocaine products for methemoglobin, a condition that causes the amount of oxygen in the blood to drop and can lead to death. The FDA also sent a letter to manufacturers outlining safety concerns.

"The FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information about the risk of methemoglobinemia in product labeling across this class of products," the agency said in its release. "Manufacturers of approved, prescription local anesthetics will have 30 days to reply to the FDA’s letter regarding these new Safety Labeling Changes."

Signs and symptoms of methemoglobin include pale, gray- or blue-colored skin, lips and nail beds; shortness of breath; fatigue; headache; lightheadedness; and rapid heart rate. The FDA says signs and symptoms may occur after using benzocaine for the first time and may appear within minutes or 1 to 2 hours after use. If any of these symptoms occur after using benzocaine, the FDA says the person should receive medical attention.

For treating teething pain, the FDA pointed to the American Academy of Pediatrics' recommendations to use a teething ring made of firm rubber or to gently rub or massage a child's gum with a finger. The AAP's recommendations also say that pain relievers or medications rubbed on gums are not useful because they was out of a baby's mouth within minutes and may present safety concerns.

You can read the full warning from the FDA here.

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