FDA: Teething anesthetics could be deadly for children

FDA: Teething anesthetics could be deadly for children

The Food and Drug Administration is asking manufacturers to stop selling their products intended for babies and toddlers. 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.

If companies do not comply, FDA officials warn that they could take regulatory action to remove these products from the market.

Products containing benzocaine carry serious risks and provide little to no benefits for treating oral pain, including sore gums due to teething, the FDA says.

More than 400 cases of benzocaine-associated methemoglobinemia have been reported to the FDA or in medical literature since 1971, according to a drug-safety communication the agency posted.

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The danger the products pose could come in the form of methemoglobinemia, a condition in which the oxygen level in blood dips dangerously low; it can be fatal. That includes Orajel Medicated Teething Gel, Orajel Medicated Nighttime Teething Gel, Orajel Medicated Daytime & Nighttime Teething Twin Pack and Orajel Medicated Teething Swabs. Pharmacists can play an important role in educating patients on the dangers of benzocaine teething products, and to recommend safe ways to relieve teething pain in infants and children.

"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 a statement.

It's also not the first teething product that the FDA has cautioned against. It is made by the New Jersey-based Church and Dwight Co. 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. They're concerned about an ingredient - the drug benzocaine. Symptoms include a gray or bluish appearance, especially in the lips and nail beds, as well as rapid breathing and an elevated heart rate. The OTC benzocaine products should only be used sparingly in adults, and children 2 years and older and not more than four times a day.

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