FDA: Don't use teething products with benzocaine

25 May, 2018, 23:25 | Author: Colin Gill
  • Health officials warn of teething gel side effects

The FDA has ordered companies to stop selling teething products containing benzocaine, and said it will take action against those who refuse to comply. The over-the-counter medicines have brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store brands and generics.

Manufacturers in the USA will have 30 days to update the product labels and "if companies do not comply, the FDA will initiate a regulatory action to remove these products from the market", the release states. Manufacturers of prescription local anesthetics containing benzocaine must also include warning information regarding the risk of methemoglobinemia, and must respond to the FDA's letter within 30 days. Specifically, regulators say that these benzocaine-containing products may be associated with a scary condition called methemoglobinemia, "the result of elevated levels of methemoglobin in the blood [which] can lead to death" by sharply reducing the amount of oxygen carried through the blood. It can cause a rare blood condition that is linked to breathing problems, which can be deadly for children. Remember not to use frozen teething rings as they may damage the gums. "Parents should use a tiny smear of fluoride toothpaste to brush baby teeth twice daily as soon as they erupt and a soft, age-appropriate sized toothbrush", the AAPD website stated.

At present several gels and creams are being sold to parents of babies and toddlers who are teething.

The FDA advised that consumers should refer to the OTC Drug Facts Label to check if the oral health drug product they are buying uses benzocaine as an active ingredient. It also warns parents not to use homeopathic teething tablets and gels.

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Now they want these products completely off the market. The symptoms can start minutes after a product is used or up to one to two hours later.

Teething can be a hard time for infants.

If lidocaine is used, healthcare staff should be familiar with appropriate dosing, proper administration techniques, and safety monitoring; benzocaine sprays are not FDA-approved to numb mucous membranes of the mouth and throat or to suppress the gag reflex during medical procedures.

The agency said parents of teething children should follow advice from the American Academy of Pediatrics.



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