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FDA’s Action to Protect Infants From Serious Blood Disorder Caused by Over-the-Counter Benzocaine Teething Products Is Long Overdue

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Note: Today, 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. If companies do not comply, the FDA will initiate action to remove these products from the market. The agency also is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

Almost four years ago, in July 2014, Public Citizen petitioned the FDA to take regulatory actions that effectively would 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.

The FDA’s action today to protect infants and children from exposure to over-the-counter oral health products containing benzocaine, which can cause methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen, comes too late for some infants and children. The agency had concluded several years ago 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.

Unfortunately, since we submitted our 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 FDA now must move swiftly to ensure that companies cease marketing oral health products containing benzocaine for the temporary relief of teething pain in infants or children.