FDA: Don't use teething products with benzocaine

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

You swing, rock and walk with your baby for what seems like hours. It's better to give your child a rubber teething ring or a gentle finger massage (frozen toys have been known to also cause oral injuries). You repeat all of the above in what seems like an endless loop of desperation as you attempt to soothe your very uncomfortable little one. The over-the-counter benzocaine products is a sample of a product that poses a serious safety risk with not apparent demonstrated benefit.

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. Lastly, the FDA has sent a letter to manufacturers asking them to stop selling teething products with benzocaine in them - and said it will take legal action against companies that refuse to comply with the FDA's warning. The FDA has urged the makers of such remedies to stop the sales of such products.

Health officials say certain teething gels can cause rare, but deadly side effects.

The FDA will also require that prescription local anesthetics for teething children update their product box warnings to let parents know that they too may lead to methemoglobinemia.

So what's a desperate parent to do?

An agency spokesperson says these products are not for use for treating sore gums due to teething because they wash out of a baby's mouth within minutes.

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Revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years.

Benzocaine is found in many popular teething products sold as gels, sprays, ointments, solutions and lozenges. If this doesn't happen, the agency may use regulatory action to take the products off the market.

It is made by the New Jersey-based Church and Dwight Co. Other Orajel products that are meant for adult use would not be stopped, the spokesperson added.

Since 2009, 119 cases of benzocaine-associated methemoglobinemia have been reported to the FDA, 4 of which were fatal.

In January 2017, the FDA warned against homeopathic teething tablets after finding "inconsistent amounts of belladonna" that sometimes far exceeded the amounts indicated on the label.

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