On May 22, the FDA issued a warning about over-the-counter products containing benzocaine, citing "serious safety concerns" and a "lack of efficacy for teething".
Health officials have previously warned consumers about benzocaine, which can cause a rare but life-threatening blood condition, especially in children under age 2. "If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market". Now, it wants teething products off the market, noting there is little evidence they actually work.
FDA commissioner Scott Gottlieb said in a release there are "no demonstrated benefits" from the benzocaine products. 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.
For treatment of teething pain, the American Academy of Pediatrics recommends using teething rings made of firm rubber (not frozen), or gently rubbing or massaging the child's gums with a finger.
Many over the counter products designed for teething pain contain benzocaine, a chemical that may pose serious health risks for infants and children. It is also asking for new warnings on benzocaine products for adults.
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. At the time, it estimated that there have been more than 400 cases of benzocaine-associated methemoglobinemia reported to the FDA or published in medical literature since 1971.
It's also not the first teething product that the FDA has cautioned against. In September 2016, the agency warned parents not to use homeopathic teething tablets and gels. Medications are usually ineffective "because they wash out of the baby's mouth within minutes", the agency said.
Dr. Lisa Thebner, a New York-based pediatrician, said parents still ask about the products with some frequency.
These new directives may have parents wondering - what are they supposed to do with a teething baby?
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