The agency is also asking companies to stop selling the products and said it will take official action to remove them from stores. In a Drug Safety Communication issued today, the agency builds on its previous warnings about risks associated with benzocaine products for methemoglobinemia. Instead, the group recommends giving babies teething rings or simply massaging their gums to relieve pain. Symptoms include rapid heart rate, lightheadedness, difficulty breathing, sleepiness, headache, skin that is pale and nails that are blue or gray. Now it says there's little evidence these products actually work. "Parents should use a tiny smear of fluoride toothpaste to brush baby teeth twice daily as soon as they erupt and a soft, age-appropriate sized toothbrush", the AAPD website stated.
According to the American Academy of Pediatrics (AAP), oral teething gels or creams are not of much use because they get washed away in saliva in a few minutes.
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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.
Benzocaine is found in many popular teething products sold as gels, sprays, ointments, solutions and lozenges. Pharmacists should advise patients experiencing any of these symptoms to seek emergency medical attention.
Teething can be a hard time for infants. Other Orajel products that are meant for adult use would not be stopped, the spokesperson added.
The FDA claimed the teething products with benzocaine has no health benefits because it must be removed immediately from the mouth.
Over-the-counter products containing the anesthetic substance benzocaine are marketed to ease the pain of gums made sore by teething.