On May 22, the FDA issued a statement that benzocaine poses a serious risk of developing a form of methemoglobinemia, a potentially fatal condition which causes oxygen levels in the blood to drop.
Parents will generally use products like Orajel with benzocaine to help alleviate the pain associated with sore gums and growing teeth in infants, babies, kids, and children. Benzocaine is also marketed to relieve sore throats, canker sores, and irritation of the mouth and gums.
Teething products containing benzocaine are not only dangerous but ineffective, as the medication can easily rinse out of the mouth where it is intended to work. The difficulty in using these medications with young children is their limited abilities to communicate the presence of symptoms or discomfort.
In addition to a safety warning, the FDA released an advisory to companies to cease manufacturing products containing the benzocaine pain reliever. Generic versions and store brands were advised to be taken off the market as well. The FDA will take immediate regulatory action should these products remain available to the consumer market.
Symptoms of methemoglobinemia can manifest within minutes or hours of being administered with benzocaine. Caregivers should immediately seek medical attention if any of the above side effects are present in their child.
The side effects of methemoglobinemia include:
- difficulty breathing
- increased heart rate
- skin or nailbeds that turn blue or gray
Benzocaine products come in a variety of forms such as ointments, sprays, solutions, gels, and lozenges.
Products currently on the market that contain benzocaine are:
- Baby Orajel
Moms and Dads should check the labels on teething products they already have at home to make sure they do not contain benzocaine.
The FDA recommends that parents and caregivers follow the American Academy of Pediatrics (AAP) guidelines for teething treatment as an alternative to over-the-counter teething medications. The AAP advises a teething ring made of hard rubber (not frozen) to be gently rubbed or massaged onto the gums to relieve teething discomfort.
The Drug Safety Communication issued this week built upon a previous warning to consumers about the potentiality of developing methemoglobinemia. In 2011, the FDA warned the consumer market about benzocaine and the correlation to methemoglobinemia. It was estimated that over 400 cases of methemoglobinemia were associated with the pain reliever in either medical journals or FDA reports since 1971.
On a similar note, in 2016 the FDA issued a warning to caregivers and parents not to use homeopathic teething tablets or gels. It was found they posed an increased risk of seizure, breathing difficulties, lethargy, muscle weakness, flushed skin, constipation, difficulty urinating, excessive sleepiness, or agitation. Homeopathic treatments are not evaluated by the FDA
Companies have made swift moves to follow the FDA requirements. The sales and marketing company for Orajel, Church & Dwight, Inc., issued a press release this week indicating an immediate withdrawal of Orajel products containing benzocaine. “The safety of our consumers and their children is our highest priority,” it said.
Effective immediately, Orajel will be discontinuing the following products:
- Orajel Medicated Teething Gel
- Orajel Medicated Nighttime Teething Gel
- Orajel Medicated Daytime & Nighttime Teething Twin Pack
- Orajel Medicated Teething Swabs
Orajel plans to review and update their Drug Facts Label on over-the-counter oral healthcare products as well.
Consumers and health care professionals are encouraged to report adverse effects of medication containing benzocaine through the FDA MedWatch Program online.