The Food and Drug Administration is asking manufacturers to stop selling their products intended for babies and toddlers. Methemoglobinemia is a risky condition that results from elevated levels of methemoglobin, causing oxygen carried through the blood to be reduced, which can ultimately lead to death. The agency said it will take action against companies that don't voluntarily remove their products for young children.
Church & Dwight Co., which sells and markets Orajel products for teething, said in a statement that the safety of its customers and their children is its highest priority, and it is immediately discontinuing the distribution and sale of Orajel teething products containing benzocaine.
Regulators have issued multiple warnings about benzocaine but deaths have continued.
"The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit", said FDA Commissioner Scott Gottlieb, M.D.
Benzocaine is the active ingredient in several over-the-counter teething medications, including Anbesol, Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, and Topex.
New warnings will be added to other benzocaine-containing products for oral use, the agency said.
For parents looking to relieve teething pain in their infants, the FDA referred to recommendations from the American Academy of Pediatrics.
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%.
The FDA also says it can be unsafe.
The FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information about the risk of methemoglobinemia in product labeling across this class of products. It also repeated a previous warning to avoid homeopathic teething products, which may have a variety of possible side effects. Educate families on the importance of reading the drug facts label to ensure products do not contain benzocaine.
Symptoms of methemoglobinemia may begin within minutes and up to two hours after the first use of benzocaine.
"It often has the word "baby" in the title, so parents will naturally reach for the product", she said.