As such, the Agency is urging manufacturers to stop marketing OTC oral drug products containing benzocaine for teething to this patient population. Methemoglobinemia is a risky condition that results from elevated levels of methemoglobin, causing oxygen carried through the blood to be reduced, which can ultimately lead to death.
Signs and symptoms include short breath and pale, gray, or blue-colored skin, lips and nails, as well as fatigue, dizziness, headache and a fast heart rate. The symptoms can start minutes after a product is used or up to one to two hours later.
Pharmacists can play an important role in postmarketing surveillance of benzocaine products by reporting methemoglobinemia cases to the FDA's MedWatch program. 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. Those marketed to adults can stay on the market but may need new label information.
This is not the first warning about benzocaine from the FDA. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Officials reviewed 119 cases of the blood disorder linked to benzocaine between 2009 and 2017, including four deaths, according to the FDA.
Cold washcloth, spoon, or chilled teething ring can also soothe the baby's gums.
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Pharmacists should educate parents to avoid using benzocaine, and other local anesthetics to treat teething pain in infants and children.
Paducah pediatrician Dr. Van Meeks says there are major concerns with long-term use of the products.
"It often has the word "baby" in the title, so parents will naturally reach for the product", she said.
"Here you have a product that doesn't really help and can induce harm", says Meeks.
Pediatrician Ashley Logan of Physicians to Children sees children who struggle during teething all the time.
Story by Jen Christensen for CNN.