According to the letter, benzocaine products marketed to adults-including Orajel, Anbesol, Cepacol, and Chloraseptic-are still considered safe, but need to contain two additional warnings: one telling users that the product shouldn't be used for children under two, or for teething, and another about the risks of methemoglobinemia. The ultimate goal here is to discontinue these treatments' marketing altogether; if companies don't play ball, "the FDA will initiate a regulatory action to remove these products from the market". It is also asking for new warnings on adult 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.
Regulators have warned about the dangers of benzocaine in the past, AP said.
"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.
For advice on treating teething pain, the FDA recommends parents and caregivers follow the American Academy of Pediatrics' (AAP) recommendation, which are to use a teething ring made of firm rubber (not frozen), or to gently rub or massage the child's gums with a finger to relieve symptoms.
If your child has ingested products with benzocaine, look for symptoms of methemoglobinemia.
The Food & Drug Administration posted a press release on its website today with the headline, "FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit".
Benzocaine is used in products to treat not just teething, but also sore throats, canker sores, and other oral irritations. These gels and creams contain the drug benzocaine that is a local anesthetic gel and can numb the area stopping the pain. The condition, called methemoglobinemia, causes a major drop in oxygen in the blood.
Teething products with benzocaine include Baby Orajel. Signs of methemoglobinemia include shortness of breath, fatigue, and pale, gray, or blue-colored skin, lips and nail beds.
The child can start showing symptoms of methemoglobinemia in few minutes after using these products.
- High gas prices won't keep these motorists home
- Everything you need to know about Battlefield V
- Phoenix ranks second in United States in population growth from 2016 to '17
- NFL anthem policy change: what they're saying around the league
- Kansas City Royals vs. Texas Rangers, 5-26-2018 - Prediction & Preview
- Flags honor veterans for Memorial Day at Holy Cross Cemeter
- Santa Fe school shooting prompts roundtable discussions with Gov. Abbott, Texas leaders
- ZTE could face fresh US$1.3b fine, Trump says
- Hearing delayed in Trump lawyer Michael Cohen's NY court case
- Judge orders Trump not to block Twitter followers in groundbreaking ruling