Teething gels pose 'serious risk' to babies, FDA warns

Teething gels pose 'serious risk' to babies, FDA warns

Twenty-seven years after the US Food and Drug Administration (FDA) approved a mild oral painkiller for over-the-counter use, the agency is reversing its stance.

In addition, the FDA has asked manufacturers of OTC benzocaine-containing oral drug products to make changes to the labeling with regard to use in adults and children over the age of 2.

The agency on Wednesday said it wants manufacturers to stop selling products intended for babies and toddlers because the products contain a drug ingredient that can cause a rare but risky blood condition that interferes with normal breathing.

Along with asking companies to stop selling children's products with benzocaine, the FDA is also requesting more warning labels on all other benzocaine oral-health products.

Benzocaine is associated with a unsafe health condition called methemoglobinemia, that results in decreased oxygen in the blood - and that could lead to death. Manufacturers of prescription local anesthetics containing benzocaine must also include warning information regarding the risk of methemoglobinemia, and must respond to the FDA's letter within 30 days.

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"Its always been an issue with the choking and this is a new warning the fda has come out with for certain children that are predisposed to this", Lykins said.

The traditional recommendation of a gentle massage with your fingers on your child's gums is the go-to treatment.

Benzocaine is marketed as a pain reliever for babies who are teething.

"Benzocaine, a local anesthetic, can cause a condition in which the amount of oxygen carried through the blood is greatly reduced", FDA officials wrote in a drug safety update. 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. Signs of methemoglobinemia include shortness of breath, fatigue, and pale, gray, or blue-colored skin, lips and nail beds. The products are sold as gels, sprays, ointments, solutions and lozenges under the OTC brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store brands and generics.

According to Church and Dwight Co.

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