Federal health officials in the U.S. warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers.
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.
The agency has been warning about the products for a decade but said reports of illnesses and deaths have continued. Now, it wants teething products off the market, noting there is little evidence they actually work.
"We urge parents, caregivers and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain," said FDA Commissioner Scott Gottlieb, in a statement.
The FDA said it will take legal action against companies that don't voluntarily remove their products for young children.
Benzocaine is also used in popular over-the-counter products for toothaches and cold sores in adults, including Orajel and Anbesol and dozens of generic drugstore brands. Products for adults can remain on the market but the FDA wants companies to add new warnings. Manufacturers have 30 days to respond to the government's request.
Benzocaine can cause a rare blood condition linked to potentially deadly breathing problems. The pain-relieving ingredient can interfere with an oxygen-carrying protein in the blood. Symptoms include shortness of breath, headache and rapid heart rate.
Teething products with benzocaine include Baby Orajel. The packaging states: "Instant relief for teething pain." It is made by the New Jersey-based Church and Dwight Co. Inc.; a company representative could not be immediately reached for comment Wednesday.
The American Academy of Pediatrics does not recommend teething creams because they usually wash out of the baby's mouth within minutes. Instead, the group recommends giving babies teething rings or simply massaging their gums to relieve pain.
The FDA issued warnings about the teething products in 2006, 2011 and 2014, but did not call for their removal from the market.
Officials reviewed 119 cases of the blood disorder linked to benzocaine between 2009 and 2017, including four deaths, according to the FDA.
In 2012, Health Canada asked companies to add new risk statements to the packaging and labelling of licensed benzocaine products (except lozenges) to warn of what it called a very rare but serious blood condition known as methemoglobinemia that can affect people with sensitivities.
Health Canada said the label changes reflected child safety and the importance of using the smallest amount possible.
"Health Canada has initiated a review of this issue and will take the FDA's recommendations into consideration," a spokeswoman said in an email to CBC News on Wednesday.
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