Over-the-counter teething medication with the drug benzocaine is a health risk for babies, according to the U.S. Food and Drug Administration.
The FDA wants all oral-health products for children with benzocaine, a type of pain reliever, to stop being marketed and sold.
In Canada, officials at Health Canada required companies in 2012 to add “risk statements” to benzocaine products. Health Canada says the pain reliever can cause a rare but serious blood condition called methemoglobinemia (MHb), which causes breathing problems and can lead to death.
“Health Canada has initiated a review of this issue and will take the FDA’s recommendations into consideration,” spokesperson Renelle Briand said in an email to Global News.
Officials say infants are at increased risk of developing MHb, as well as those with heart conditions and other pre-existing conditions. More information is available on the Health Canada website here.
Benzocaine is found in gels, sprays and lozenges for teething, canker sores, sore throats and toothaches, for both adults and children.
Examples of products include Baby Orajel, Little Teether’s Oral Pain Relief Gel, and Anbesol Gels, along with their adult versions.
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Officials say if you or your child show any symptoms, which include weakness, confusion, headache, difficulty breathing and/or pale-, grey- or blue-coloured skin, you should go see a health practitioner immediately.
Along with asking companies to stop selling children’s products with benzocaine, the FDA is also requesting more warning labels on all other benzocaine oral-health products.
FDA commissioner Scott Gottlieb said in a release there are “no demonstrated benefits” from the benzocaine products.
Manufacturers in the U.S. 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.
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