Parents can rest easier knowing that dangerous and ineffective over-the-counter medications to ease teething pain are being pulled from store shelves.
- 35 Number of cases of a benzocaine-associated blood disorder reported to the FDA.
- 2 Number of deaths from the benzocaine-associated blood disorder.
- 4 months The age of one of the infants who died after getting a benzocaine treatment for sore gums.
In May 2018, the U.S. Food and Drug Administration (FDA) announced that over-the-counter oral health products containing the pain reliever benzocaine no longer should be marketed for teething pain or used to treat infants and children younger than 2. The agency also requested that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.
The action came almost four years after Public Citizen petitioned the FDA to effectively ban over-the-counter infant teething products containing benzocaine and significantly increase warnings about other products containing benzocaine.
On Sept. 21, 2017, Public Citizen sued the FDA to compel the agency to respond to the citizen petition.
Benzocaine can cause methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen. The FDA concluded several years earlier that over-the-counter benzocaine products should not be used to treat teething pain in infants and children because they are ineffective for this use and can cause this rare, but potentially deadly, adverse reaction.
But the FDA dragged its feet.
Since Public Citizen submitted its petition in 2014, the FDA continued to receive multiple new reports of serious adverse reactions to benzocaine, including adverse reactions in children who were given over-the-counter benzocaine oral health care products. Faster action by the agency may have prevented some of these injuries.
The agency undoubtedly would not have taken these actions now had Public Citizen not petitioned the agency to do so and sued the agency to compel it to respond to our petition. Although we support the FDA’s action, it comes too late for some infants and children.Dr. Michael Carome, director of Public Citizen’s Health Research Group