Twenty-seven years after the US Food and Drug Administration (FDA) approved a mild oral painkiller for over-the-counter use, the agency is reversing its stance. The agency is also asking manufacturers to add warnings on all oral health products that contain the numbing ingredient.
The headline was followed with, "Agency urges companies to discontinue teething products, include new warnings for other OTC benzocaine products and revise warnings for approved prescription local anesthetic drugs".
Regulators already released warnings about the dangers of benzocaine, but deaths remained a problem.
The FDA said it will take legal action against other companies that don't voluntarily comply as soon as possible.
According to the American Academy of Pediatric Dentistry (AAPD), it is never too early to start brushing baby gums with a soft infant toothbrush (or just a cloth and water) every day. The AAP notes that pain relievers and medications that are rubbed on the gums for teething are not useful because they wash out of the baby's mouth within minutes and may present safety concerns.
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The FDA issued warnings about the teething products in 2006, 2011 and 2014, but did not call for their removal from the market. Educate families on the importance of reading the drug facts label to ensure products do not contain benzocaine. They are sold as brands Orajel and Anbesol for adults. It is made by the New Jersey-based Church and Dwight Co. Methemoglobinemia can cause red blood cells to stop carrying needed oxygen.
Consumers should stop using over-the-counter teething products that contain benzocaine because they pose a serious health threat to infants and young children, USA health officials warned Wednesday.
They also warn against using homeopathic alternatives.
Benzocaine is found in gels, sprays and lozenges for teething, canker sores, sore throats and toothaches, for both adults and children. Signs of methemoglobinemia include shortness of breath, fatigue, and pale, gray, or blue-colored skin, lips and nail beds. "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".