By Rebecca Gaines
July 7, 2014
In June 2014, the Food and Drug Administration (FDA) warned parents that lidocaine should not be used on infants and young children to soothe teething pain.
The FDA has issued a black box warning, its most serious warning, to be added to the drug label of lidocaine solution. Lidocaine is a common painkiller that parents sometimes use to ease the pain of infants who are teething, rubbing the pain reliever on the gums of their teething babies. However, the FDA has never approved lidocaine specifically to treat teething pain. The FDA now realizes that the risks of lidocaine are greater than its benefits for young children. The agency has reviewed 22 reports of “serious adverse reactions,”1 including six deaths and 11 hospital admissions.
Why is lidocaine dangerous, and why has it taken so many years to realize it? The answer is simple: It is too easy for an adult or child taking care of an infant to give too much lidocaine, and this can cause seizures, brain injury, or heart problems.
There are many safe, non-toxic ways to treat teething. The FDA recommends that families follow the advice of the American Academy of Pediatrics (AAP), such as using a chilled teething ring or “gently rubbing or massaging the gums with one of your fingers.” 2 The AAP also notes that using topical medications on gums is not helpful because they wash out in a few minutes. In 2011, FDA warned that parents and caregivers not use over-the-counter topical benzocaine for teething and mouth pain. Benzocaine liquids and gels can cause a rare but potentially fatal condition called methemoglobinemia.1
The bottom line: teething pain should not need medical treatment. If your child is experiencing extreme pain or has a high fever, teething is probably not the cause and you should contact a medical professional. 3
- U.S. Food and Drug Administration. (June 2014). FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm402240.htm ▲
- Gaffney, Alexander. (June 2014). FDA Recommends Against Use of Painkillers for Teething Pain. Regulatory Affairs Professional Society. Retrieved from http://www.raps.org/regulatory-focus/news/2014/06/19595/FDA-Warns-on-Painkillers-for-Teething-Pain/?utm_source=social&utm_medium=post&utm_campaign=RFnews ▲
- American Academy of Pediatrics. (December 2013). Teething: 4-7 months. Retrieved from: http://www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/pages/Teething-4-to-7-Months.aspx ▲