FDA: popular teething gels are not safe for children

Stephanie Nano  APOrajel is displayed for sale in a pharmacy in New York

Stephanie Nano APOrajel is displayed for sale in a pharmacy in New York

The FDA has urged the makers of such remedies to stop the sales of such products.

These new directives may have parents wondering - what are they supposed to do with a teething baby? Benzocaine is a topical anesthetic used in teething ointments, gels, lozenges and sprays. Benzocaine can cause rare but deadly side effects in children, especially those two-years-old and younger. At the time, it estimated that there have been more than 400 cases of benzocaine-associated methemoglobinemia reported to the FDA or published in medical literature since 1971.

If your child is having teething pain, the FDA says to try massaging their gums with your finger or give your child a teething ring made of firm rubber to chew on.

FDA officials are requesting that these products no longer be marketed or sold - or, at the least, that companies add warnings with up to date drug safety information to all oral health products containing benzocaine.

The FDA expects manufactures to voluntarily remove their products as soon as possible.

The agency said parents of teething children should follow advice from the American Academy of Pediatrics. The AAP notes that pain relievers and medications that are rubbed on the gums for teething are not useful because they wash out of the baby's mouth within minutes and may present safety concerns. It can cause lowering of oxygenation in the body and lead to shortness of breath, rapid heart rates and headaches.

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. However the labels of these products need to carry appropriate warnings against use in babies and toddlers.

New Jersey-based manufacturer Church and Dwight Co.

The headline was followed with, "Agency urges companies to discontinue teething products, include new warnings for other OTC benzocaine products and revise warnings for approved prescription local anesthetic drugs".

The FDA claimed the teething products with benzocaine has no health benefits because it must be removed immediately from the mouth. A study comparing the relative ability of benzocaine and lidocaine to make methemoglobin showed that benzocaine generated much more methemoglobin than lidocaine in a red blood cell model.

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