FDA Warns on OTC Teething Products with Benzocaine

The US Food and Drug Administration issued a warning to consumers Wednesday to stop using over-the-counter teething products that contain benzocaine

The US Food and Drug Administration issued a warning to consumers Wednesday to stop using over-the-counter teething products that contain benzocaine

Benzocaine can cause rare but deadly side effects in children, especially those two-years-old and younger.

The agency asked manufacturers to stop the sale of teething products and include warnings for other over-the-counter oral health products which contain benzocaine, according to a statement released on May 23. The agency on Wednesday 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. Products for adults can remain on the market but the FDA wants companies to add new warnings. Inc., makers of this product based in New Jersey yesterday, they would stop the further production of the four different Orajel teething brands as well as Orajel Medicated Teething Swabs. This unsafe condition is the result of elevated levels of methemoglobin in the blood and it can lead to death. FDA Commissioner Dr. Scott Gottlieb also noted that benzocaine, which is an anesthetic, can pose a safety risk when used on children. More than 400 cases have been reported to the FDA or appear in the medical literature, the agency said in a data summary.

On the American Academy of Pediatrics site, HealtyChildren.org, the page on teething babies has a warning that reads, "Stay away from teething tablets that contain the plant poison belladonna and gels with benzocaine".

Pharmacists should educate parents to avoid using benzocaine, and other local anesthetics to treat teething pain in infants and children.

Those concerned by the warning are advised to check if benzocaine is an active ingredient in products, and keep an eye out for symptoms of methemoglobinemia if they are used. The condition, called methemoglobinemia, causes a major drop in oxygen in the blood. Rapid heart rate, headache, lightheadedness, difficulty in breathing, sleepiness, pale skin, and blue or gray eyes are some of the symptoms of methemoglobinemia.

Benzocaine is found in gels, sprays and lozenges for teething, canker sores, sore throats and toothaches, for both adults and children.

Teething products with benzocaine include Baby Orajel.

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