Benzocaine-containing products sold over the counter to relieve babies' teething pain are too risky and should no longer be sold, the FDA said Wednesday.
The U.S. Food and Drug Administration said that various gels and creams containing the drug benzocaine (BEN-zoh-keyn) can cause rare but deadly side-effects in children, especially those 2 years and younger.
Benzocaine is found in gels, sprays and lozenges for teething, canker sores, sore throats and toothaches, for both adults and children.
The FDA said it will take legal action against other companies that don't voluntarily comply as soon as possible.
Out of 119 cases reviewed in detail, mostly involving adults (with the benzocaine-containing product most commonly used during transesophageal echocardiography), 36 reported methemoglobinemia levels of 30% to 55% - a normal level ranges from 1% to 2%. In a Drug Safety Communication issued today, the agency builds on its previous warnings about risks associated with benzocaine products for methemoglobinemia. 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.
Check your teething relief product labels to see if benzocaine is an active ingredient. Symptoms include rapid heart rate, lightheadedness, difficulty breathing, sleepiness, headache, skin that is pale and nails that are blue or gray.
The academy has noted that pain relievers and gels used on the gums of teething children are generally not effective because they wash out of a baby's mouth within minutes, FDA said.
This is not the first warning about benzocaine from the FDA. The FDA also outlined these safety concerns in letters that the agency sent to manufacturers of these products. The FDA also previously cautioned parents and caregivers to not give certain homeopathic teething tablets to children and to seek advice from their health care professional for safe alternatives. "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".
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