The FDA is warning parents not to use over-the-counter teething products and remedies containing benzocaine, a local anesthetic used as a numbing agent, which could be dangerous, even deadly, to infants and young children under 2.
The FDA is also ordering manufacturers of teething products marketed for use by infants and young children to stop making these products, and to remove them from the market. The FDA further ordered manufacturers to add warnings to other products containing benzocaine that these products are not to be used as teething remedies, and should never be given to infants and children under 2 years of age.
When given to infants and young children to relieve teething symptoms, benzocaine can cause a rare, sometimes fatal, blood condition known as methemoglobinemia, which substantially reduces the amount of oxygen in the blood.
FDA Commissioner Scott Gottlieb said, ‘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.’
Symptoms of methemoglobinemia may appear within just a few minutes or a couple of hours after placing benzocaine products on the gums of a teething infant or young child.
Seek immediate medical attention if any of these signs or symptoms appear:
Symptoms can occur with first-time use, but users are not immune from suffering serious side effects even if a benzocaine product was used previously without side effects.
Over-the-counter brand name teething products that contain benzocaine include:
Benzocaine is contained in gels, sprays, ointments, oral solutions, and lozenges. Parents should also check the labels on generic and store brand teething products for benzocaine. Benzocaine is a numbing agent also used in sore throats, canker sores, and gum and mouth irritation.
Between 2009 and 2017, FDA officials investigated 119 cases of the blood disorder in children linked to benzocaine use, including 4 deaths.
This is not the only teething remedy against which the FDA has issued warnings against use. Last year, the FDA warned parents against using homeopathic teething products containing belladonna, which may be toxic to infants and young children.
The FDA and the American Academy of Pediatrics (AAP) found there is minimal evidence these teething products even work. The AAP contends these products provide only short-term relief, if any, because the benzocaine product is usually washed out after a few minutes of placing it on the swollen gums. The AAP recommends either rubbing a finger gently over the swollen, teething gums, or giving the teething child a teething ring or something firm and cold to gnaw on to help relieve pain.