Federal health officials in the USA warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers.
The FDA is warning consumers to immediately stop using all baby teething products that contain benzocaine because they can pose a "serious risk" to infants and children. The ultimate objective 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". In a Drug Safety Communication issued today, the agency builds on its previous warnings about risks associated with benzocaine products for methemoglobinemia.
In rare cases, it can affect how the red blood cells carry oxygen. That includes Orajel Medicated Teething Gel, Orajel Medicated Nighttime Teething Gel, Orajel Medicated Daytime & Nighttime Teething Twin Pack and Orajel Medicated Teething Swabs.
The FDA wants all oral-health products for children with benzocaine, a type of pain reliever, to stop being marketed and sold. They include pale, gray- or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; headache; lightheadedness; and a rapid heart rate.
FDA commissioner Scott Gottlieb said in a release there are "no demonstrated benefits" from the benzocaine products.
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The FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information about the risk of methemoglobinemia in product labeling across this class of products. Officials reviewed 119 cases of the blood disorder linked to benzocaine between 2009 and 2017, including four deaths, according to the FDA. The FDA also outlined these safety concerns in letters that the agency sent to manufacturers of these products.
The American Academy of Pediatrics has told parents to use alternatives such as hard rubber teething products and to avoid frozen teething toys, as they can injure a baby's mouth and cause more pain. It is made by the New Jersey-based Church and Dwight Co.
The US Food and Drug Administration is warning parents about potentially deadly risks of teething remedies that contain a numbing ingredient used in popular brands like Orajel.
"It often has the word "baby" in the title, so parents will naturally reach for the product", she said.