The FDA is warning health-care providers and parents that rubbing topical anesthetics such as Anbesol or Orajel onto the sore gums of teething babies can lead to can lead to methemoglobinemia — an oxygen deprivation disorder that is sometimes fatal.
The source of concern is benzocaine, the active ingredient in most over-the-counter products for mouth and gum pain, FDA pharmacist Mary Ghods, RPH, said in a statement.
Common OTC benzocaine-containing products include Anbesol, Hurricaine, Orajel, Baby Orajel and Orabase.
Risk is greatest among children aged younger than two years, the group most likely to experience teething pain, according to the FDA. The agency first warned about the risk of methemoglobinemia with benzocaine in 2006, and has since received reports of 29 instances, 19 of which occurred in children and 15 of those cases among children younger than 2 years.
Although the FDA issued a second warning in April 2011, health officials remain concerned that parents may have difficulty recognizing signs and symptoms of methemoglobinemia, which can occur anywhere from minutes to hours after benzocaine use. Furthermore, children may be symptomatic after first use or only after several uses.
Health care providers should advise parents to be on the look-out for the following methemoglobinemia symptoms:
- Pale, gray or blue-colored skin, lips and nail beds
- Shortness of breath
- Rapid heart rate
Parents whose children exhibit any of these symptoms should discontinue benzocaine use and seek medical treatment immediately. “If treatment is delayed, methemoglobinemia may cause permanent injury to the brain and body tissues, and even death, from the insufficient amount of oxygen in the blood,” the FDA warned.
Alternatives to gum-numbing teething remedies include chilled teething rings and gently rubbing or massaging the baby’s gums with the fingers, the American Academy of Pediatrics recommends. If these remedies fail, parents should seek the advice of a health-care provider.
In addition to consumer use of OTC teething products, clinicians and dentists may use benzocaine-containing sprays to numb the mouth and throat in adult patients for procedures such as transesophageal echocardiograms, endoscopy and feeding tube placements, the FDA noted.
Adults with heart disease, asthma, bronchitis, or emphysema, as well as smokers, are also at risk for metheglobinemia and should be informed of this risk prior to undergoing such procedures.
OTC products containing benzocaine are not currently required to carry warnings about methemoglobinemia on the label. The FDA suggests health-care providers advise patients to store these products out of the reach of children, use these medications sparingly (no more than four times daily) and check OTC-product labels to see if benzocaine is an ingredient.