FDA Demands Orajel to Soothe Teething Babies Be Taken Off Market

(Bloomberg) -- Consumer-health companies must stop selling products such as Baby Orajel to parents with teething infants, U.S. health regulators said, given the risk of developing a potentially deadly condition that reduces oxygen levels in the blood.

The Food and Drug Administration on Wednesday asked companies including Church & Dwight Co., maker of the Baby Orajel brand, to voluntarily stop selling oral anesthetics that contain benzocaine to soothe teething pain. The agency also wants all products that contain the pain reliever to include warnings about infant use, including Colgate-Palmolive Co.’s Orabase and Prestige Brands Holdings Inc.’s Chloraseptic for treating sore throats.

Pfizer Inc.’s Anbesol gel and liquid for toothaches and cold sores already carries a warning for the rare condition, called methemoglobinemia.

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. The FDA analyzed 119 of the episodes from February 2009 to October 2017, including 11 linked to patients younger than 2 years old. In one of those cases, the patient died.

The FDA warned about the potential dangers of benzocaine in 2006 and 2011, and has said parents shouldn’t use the products in children younger than 2. Signs of methemoglobinemia include shortness of breath, fatigue, and pale, gray, or blue-colored skin, lips and nail beds.

“Because of the lack of efficacy for teething and the serious safety concerns we’ve seen with over-the-counter benzocaine oral health products, the FDA is taking steps to stop use of these products in young children and raise awareness of the risks associated with other uses of benzocaine oral health products,” FDA Commissioner Scott Gottlieb said in a statement.

The American Academy of Pediatrics says pain relievers parents rub on their children’s gums aren’t useful, as they can wash out of a baby’s mouth within minutes. Instead, the academy suggests trying teething rings made of firm rubber or massaging a child’s gums.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett

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