May 25, 2018

FDA Agrees With Public Citizen, Responds to Petition by Telling Companies to Stop Marketing Over-the-Counter Benzocaine Teething Products

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

Note: On Thursday, the U.S. Food and Drug Administration (FDA) issued a response to Public Citizen’s July 2014 petition to the agency 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. In response to the lawsuit, the agency made a commitment to respond to Public Citizen’s citizen petition by the end of this month.

The FDA agreed with Public Citizen that over-the-counter oral health care products containing benzocaine should never be used in infants under any circumstances, even with the advice and supervision of a health care professional, because of the risk of methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen. The agency also agreed with us that all other over-the-counter benzocaine products should include a warning about the risk of this fatal adverse effect in the product labeling.

Rather than pursuing the specific rulemaking that we had requested in our petition – which we recognized would be a time-consuming process – the agency instead has individually written to each manufacturer, repackager, relabeler and distributor of over-the-counter oral health care products containing benzocaine and asked them to cease marketing benzocaine products for teething pain in infants and children younger than 2 and to add warnings to the labeling of all other benzocaine products that are similar to those we had sought in our petition. These actions are intended to achieve the outcomes we sought in our petition. The FDA also announced that if companies do not comply, the agency will initiate action to remove these products from the market.

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. According to the FDA, since May 2014 — just before we submitted our petition — at least 35 cases of benzocaine-associated methemoglobinemia had been reported to the agency or in the medical literature, including two deaths. One death occurred in a 4-month-old infant given a benzocaine-containing OTC product to treat sore gums due to teething. Faster action by the agency may have prevented many of these events. Indeed, the FDA had overwhelming evidence nearly a decade ago that the risks of over-the-counter benzocaine products for teething pain in infants far outweigh their benefits. The agency easily could have completed the regulatory actions requested in our petition years ago.

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