Parents warned to stop using benzocaine teething products

Parents warned to stop using benzocaine teething products

Parents warned to stop using benzocaine teething products

In addition, the FDA has asked manufacturers of OTC benzocaine-containing oral drug products to make changes to the labeling with regard to use in adults and children over the age of 2. If this doesn't happen, the agency may use regulatory action to take the products off the market. 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. In a Drug Safety Communication issued today, the agency builds on its previous warnings about risks associated with benzocaine products for methemoglobinemia. It may lead to a life-threatening condition called methemoglobinemia when oxygen in the blood dips to dangerously low levels. Symptoms include rapid heart rate, lightheadedness, difficulty breathing, sleepiness, headache, skin that is pale and nails that are blue or gray. The FDA has urged the makers of such remedies to stop the sales of such products.

In January 2017, the FDA warned against homeopathic teething tablets after finding "inconsistent amounts of belladonna" that sometimes far exceeded the amounts indicated on the label.

Do Teething Babies Need Medicine on Their Gums? These can develop in minutes or up to two hours after using the drug.

For parents looking to relieve teething pain in their infants, the FDA referred to recommendations from the American Academy of Pediatrics.

The FDA highlighted in a statement that products such as Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store-brand alternatives, have benzocaine as an active ingredient.

Companies are being urged to voluntarily halt sales of-and parents are being urged to eschew-these sore gum treatments, which are commonly used to treat pain related to teething and other various mouth irritations. I have, for a while, cautioned against topical gels because of the danger, and babies are in the population at the highest risk for harm, and if you look at the risk versus benefit, it's not even all that helpful.

In previous communications, the FDA had warned the public about reports of methemoglobinemia in individuals using OTC benzocaine gels and liquids as well as benzocaine sprays for medical procedures.

Over-the-counter products containing the anesthetic substance benzocaine are marketed to ease the pain of gums made sore by teething.

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