FDA Says Teething Gels Pose a 'Serious Risk' to Babies
The Food and Drug Administration is warning parents that teething gels made with benzocaine are not safe for little ones. They are asking that these products be taken off the market.
For a decade, the Food and Drug Administration has issued warnings about the numbing ingredient benzocaine, the active ingredient in many teething gels marketed for babies and toddlers. Now, given persistent reports of illnesses and deaths associated with teething gel products, the FDA has taken even more definitive action.
On Wednesday, May 23, federal health officials warned parents that gels and creams containing benzocaine can cause rare but deadly side effects in children, especially those 2 years and younger. They've also asked that these teething products be taken off shelves.
"The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit," said FDA Commissioner Scott Gottlieb, M.D. "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. In addition to our letters to companies who make these products, 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."
The FDA also noted that if companies don't voluntarily take their products geared toward kids off shelves, they'll pursue legal action.
In response to the news, New Jersey-based manufacturer Church and Dwight Co. Inc. said it will discontinue four Orajel teething brands, including Orajel Medicated Teething Swabs. “We are not discontinuing other Orajel products, which represent the majority of our Orajel offering,” the company said in an emailed statement, according to Time.com.
Benzocaine has been linked to a rare blood condition called methemoglobinemia, which causes a reduction in blood oxygen and can be fatal. There have been about 400 cases of benzocaine-related methemoglobinemia, including 119 cases between February 2009 and October 2017, according to the FDA, which has issued several warnings over the years.
Kathleen A. Neville, MD, a spokesperson for the American Academy of Pediatrics and professor of pediatrics at the University of Arkansas in Little Rock tells Parents.com, "The FDA’s warning about benzocaine fills a much needed gap in providing safety for children. Moreover, I am really happy that the FDA is continuing to work with congress to change the monograph process. I think that consumers often believe that because a drug is over-the-counter, it is safe and proven to be effective. This is not the case, and benzocaine is a perfect example of this phenomenon. To my knowledge, there are no randomized controlled trials proving the efficacy of benzocaine containing products in children, and we know that they are not safe. The risks, including death, far outweigh the potential benefits (relief of mild pain) for teething, etc., especially since there are safe alternatives."
To that end, the AAP recommends the following safe methods to help relieve teething pain: firm rubber (but not frozen) teething rings and simply massaging your L.O.'s gums.