FDA warns: Don’t let your children sink their teeth into benzocaine

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Over-the-counter teething gels containing a popular numbing agent pose a "serious risk" to babies and young children, federal health officials warned Wednesday (May 23). The agency today announced that OTC oral health products containing the pain reliever benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed and is asking companies to stop selling these products for such use. The ultimate goal here is to discontinue these treatments' marketing altogether; if companies don't play ball, "the FDA will initiate a regulatory action to remove these products from the market". Specifically, regulators say that these benzocaine-containing products may be associated with a scary condition called methemoglobinemia, "the result of elevated levels of methemoglobin in the blood [which] can lead to death" by sharply reducing the amount of oxygen carried through the blood.

Health officials have previously warned consumers about benzocaine, which can cause a rare but life-threatening blood condition, especially in children under age 2. Inc., said Wednesday it would discontinue its four Orajel teething brands, including Baby Orajel 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. Symptoms include rapid heart rate, lightheadedness, difficulty breathing, sleepiness, headache, skin that is pale and nails that are blue or gray.

"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.

This is not the first warning about benzocaine from the FDA.

The traditional recommendation of a gentle massage with your fingers on your child's gums is the go-to treatment. Benzocaine products are not effective for teething since they wash out of the mouth within minutes. "In addition, we are adding warning statements to more clearly identify the risks and symptoms presented by methemoglobinemia, a rare but serious condition associated with the use of benzocaine".

"It often has the word "baby" in the title, so parents will naturally reach for the product", she said.

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