FDA officials are requesting that these products no longer be marketed or sold - or, at the least, that companies add warnings with up to date drug safety information to all oral health products containing benzocaine.
The FDA said it will take legal action against companies that don't voluntarily remove their products for young children. The agency has been warning the public about the dangers of these products, but reports of illnesses and deaths over the past decade have continued.
The danger the products pose could come in the form of methemoglobinemia, a condition in which the oxygen level in blood dips dangerously low; it can be fatal. "This condition, called methemoglobinemia, can be life-threatening and result in death". The recommendations include using a teething ring made of firm rubber (but not frozen), or to gently rub or massage the child's gums with a finger. These include pale, gray- or blue-colored skin, lips and nail beds; shortness of breath; fatigue; headache; lightheadedness; and rapid heart rate. The FDA has urged the makers of such remedies to stop the sales of such products. 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.
At present several gels and creams are being sold to parents of babies and toddlers who are teething.
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One major manufacturer, Church and Dwight Co.
The drug is found in popular over-the-counter brands like Orajel and Anbesol, AP said. These can develop in minutes or up to two hours after using the drug. If any of these symptoms occur after using benzocaine, the person should receive medical attention immediately.
Teething can be a hard time for infants. The FDA recently advised parents to stop using such products that contain benzocaine. Now, it wants teething products off the market, noting there is little evidence they actually work. 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.
Benzocaine is not the only teething product the FDA has warned against.