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FDA Alert – Avoid Benzocaine Teething Products

Written by Consumer Guide to Dentistry   Last modified on May 30, 2018

Primary teeth (baby teeth) typically begin to erupt when a child is 6-to-12 months old. The teething process can interfere with babies’ sleeping and eating habits, in addition to causing general fussiness, irritability and excessive drooling. But it’s an unavoidable part of growing up.

Fortunately, there are a number of things parents can do to help minimize the discomfort and facilitate the process, (check out our 7 Helpful Teething Tips for New Parents) such as getting teethers for children to chew on.

Many types of teething products are available, some of which may prove more effective than others from child to child. Parents are urged to try out different types of teething products to find the best fit for their child. However, a recent warning from the FDA urges parents with children under the age of two to avoid over-the-counter teething products that contain benzocaine.

“Because of the lack of efficacy for teething and the serious safety concerns we’ve seen with over-the-counter benzocaine oral health products, the FDA is taking steps to stop use of these products in young children and raise awareness of the risks associated with other uses of benzocaine oral health products.” – FDA Commissioner Dr. Scott Gottlieb

What is Benzocaine?

Benzocaine is a type of local anesthetic used for a variety of purposes, but most commonly associated with topical ointments and gels. Application of benzocaine can help relieve pain and discomfort associated with sunburn, poison ivy, small wounds and other minor issues, by deadening nerve endings in the skin. Benzocaine can also be found as the active ingredient in a number of oral health products used to relieve the pain associated with toothaches, canker sores and other oral irritants.

Although generally considered to be safe, benzocaine can be hazardous for children. The FDA now wants parents to know about it. Furthermore, the FDA states that benzocaine teethers are not an effective solution because of the fact that the anesthetic is typically washed from the mouth quickly.

Methemoglobinemia Risk

The source of the FDA’s concern vis-à-vis benzocaine is the potential for it to cause methemoglobinemia, a potentially life-threatening condition marked by a dangerous dip of oxygen levels in the blood. Symptoms associated with methemoglobinemia can include:

  • Rapid heart rate
  • Breathing problems
  • Lightheadedness
  • Fatigue
  • Headache
  • Pale skin
  • Blue/gray nails

Benzocaine-induced methemoglobinemia can occur within minutes of application, but symptoms may not present for one or two hours. Parents who suspect their child is suffering from the condition are advised to seek medical attention immediately.   

FDA Warning

In addition to warning parents to avoid benzocaine teething products, the agency also alerted companies that manufacture these products that it will take regulatory action to get the products removed from stores should the companies discontinue production.

Benzocaine products marketed to adults are not included in this warning, but the FDA will evaluate whether additional labeling information should be required. (Adults and children over the age of 2 are less at risk of developing methemoglobinemia as a result of benzocaine use, but it is possible for anyone to develop the condition.)

The best way to ensure that you are choosing safe and effective teething products for your child is to speak with a pediatric dentist or pediatrician. They can help guide you to products that will help to relieve the symptoms without compromising health.

For more information about the warning, check out the FDA release