FDA Warns Against Using OTC Benzocaine Teething Products

Faith Castro
May 25, 2018

The ultimate objective here is to discontinue these treatments' marketing altogether; if companies don't play ball, "the FDA will initiate a regulatory action to remove these products from the market".

Out of 119 cases reviewed in detail, mostly involving adults (with the benzocaine-containing product most commonly used during transesophageal echocardiography), 36 reported methemoglobinemia levels of 30% to 55% - a normal level ranges from 1% to 2%. These include pale, gray- or blue-colored skin, lips and nail beds; shortness of breath; fatigue; headache; lightheadedness; and rapid heart rate.

The agency has warned parents about certain teething products in the past.

For treatment of teething pain, the American Academy of Pediatrics recommends using teething rings made of firm rubber (not frozen), or gently rubbing or massaging the child's gums with a finger.

Benzocaine is also used in popular over-the-counter products for toothaches and cold sores in adults, including Orajel and Anbesol and dozens of generic drugstore brands.

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"Because of the lack of efficacy for teething and the serious safety concerns we've seen with over-the-counter benzocaine oral health products, the FDA is taking steps to stop use of these products in young children and raise awareness of the risks associated with other uses of benzocaine oral health products", FDA Commissioner Dr. Scott Gottlieb said in a statement. The latest target? Children's gel teething products that contain the painkiller benzocaine.

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. At that time, the FDA was aware that methemoglobinemia was a rare reaction to benzocaine; it had received a total of 319 reports of this particular complication, not limited to children. In 2011, the agency warned consumers about the methemoglobinemia potential of the products. There are probably additional cases that weren't documented.

Wednesday's action comes more than four years after the consumer advocacy group Public Citizen petitioned the FDA to stop sales of teething products. Medications are usually ineffective "because they wash out of the baby's mouth within minutes", the agency said. It suggests that parents can rub their babies' gums to give them temporary relief.

Teething products with benzocaine include Baby Orajel.

New Jersey-based manufacturer Church and Dwight Co. I have, for a while, cautioned against topical gels because of the danger, and babies are in the population at the highest risk for harm, and if you look at the risk versus benefit, it's not even all that helpful.

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