FDA Announcement on OTC Teething Gels

May 28, 2018

This past week the Food and Drug Administration (FDA) made a very important announcement regarding a common product used by many parents.

Over-the-counter (OTC) teething gels, such as Orajel, Orabase, Anbesol and Cepacol use the active ingredient benzocaine to help numb the area and alleviate teething symptoms. This topical anesthetic numbs the area for a limited amount of time causing temporary relief. The American Academy of Pediatric Dentistry (AAPD) in the past has discouraged their use due to potential toxicity in infants.

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Now, the FDA is taking an even stronger stance on these products. They have starting by asking companies that sell benzocaine-containing products to not market them for teething infants as well as stop selling the products for that intended use. The FDA then stated if the companies do not comply with this request, they will take regulatory action in order to remove the products from the market.

The reason for this announcement is due to the growing research and evidence showing benzocaine’s association with methemoglobinemia. This is a dangerous condition that can affect the way your infant’s red blood cells carry and distribute oxygen to the body. With methemoglobinemia the amount of oxygen that is carried through the blood is greatly reduced, which can leave to adverse events, including death.

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While discussing teething it is also important to re-visit another product that the FDA has taken a stance on in the past. Some homeopathic teething tablets contain unregulated and inconsistent amounts of belladonna, a toxic substance, even exceeding the amount claimed on the product’s label. The FDA, in 2017, urged the recall of Hyland’s Teething Tablets due to risk of seizures, difficulty breathing and even death. In 2016 there was a similar issue with three other belladonna-containing homeopathic teething products.

Paramount Pediatric Dentistry, along with the AAPD, American Academy of Pediatrics (AAP) and the FDA recommend other palliative treatment during teething. Gently massage the child’s gum with a finger, use a firm rubber teething ring or a cold washcloth for the child to chew on. OTC analgesics, such as Children’s Tylenol or ibuprofen can also help relieve discomfort. Do not use frozen items, as that can cause a frozen burn to the child’s gingiva.

Teething can be a very stressful and sleepless time for both you and your child. We understand that parents want to find a reprieve from the pain for their child. However, we want to make sure that everyone gets through this difficult but exciting rite of passage safely. Please if you have any questions about teething or any of this new information, feel free to contact Dr. Frady or Dr. Belisle at our office!

FDA Announcement on Teething Gels:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm

FDA Announcement on Belladonna-containing Homeopathic Teething Products:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm


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