FDA warns against using teething remedies for babies

By Dr. Ananya Mandal, MDMay 24 2018

According to health officials at the Food and Drug Administration (FDA), popular teething remedies for babies may not be free from dangers. The officials in their statement this Wednesday (23rd May 2018), say these remedies normally contain a numbing agent that numbes the gums of the babies and prevent teething woes. The FDA has urged the makers of such remedies to stop the sales of such products.

Image Credit: Tolikoff Photography

At present several gels and creams are being sold to parents of babies and toddlers who are teething. These gels and creams contain the drug benzocaine that is a local anesthetic gel and can numb the area stopping the pain. Benzocaine has been found to have deadly adverse effects especially when used in children below the age of two say the officials. For the past decade, the agency has been urging parents not to buy these products for their babies because of the reports of deaths and illnesses associated with the use of these teething gels and creams.

Now they want these products completely off the market. “We urge parents, caregivers and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain,” said FDA Commissioner Scott Gottlieb in his statement. The FDA has warned companies of legal action if these products are not removed from the market and their sales are not stopped for babies. Manufacturers would be complying soon with these new directives.

According to the American Academy of Pediatrics (AAP), oral teething gels or creams are not of much use because they get washed away in saliva in a few minutes. The AAP does not recommend these gels and suggests teething rings and massaging the gums to ease the teething pain.

Benzocaine is found to cause a rare blood disorder methhemoglobinemia, that is associated with severe and often fatal breathing problems. It can cause lowering of oxygenation in the body and lead to shortness of breath, rapid heart rates and headaches.

Benzocaine, a local anesthetic agent is also found in over-the-counter products that are used for mouth sores, mouth ulcers, toothaches, cold sores etc. They are sold as brands Orajel and Anbesol for adults. These products may remain on the shelves for adults say the FDA. However the labels of these products need to carry appropriate warnings against use in babies and toddlers. At present the package of Baby Orajel says, “Instant relief for teething pain.”

According to Church and Dwight Co. Inc., makers of this product based in New Jersey yesterday, they would stop the further production of the four different Orajel teething brands as well as Orajel Medicated Teething Swabs. Other Orajel products that are meant for adult use would not be stopped, the spokesperson added.

The FDA warnings regarding benzocaine in baby teething products have been issued in the past in 2006, 2011 and 2014. Between 2009 and 2017 there have been 119 cases of the rare blood disorder associated with benzocaine including deaths of four babies associated with the use of benzocaine. These have all prompted the directive on removal of these products.