May 23, 2018
The U.S. Food and Drug Administration is warning consumers that over-the-counter (OTC) teething products containing benzocaine pose a serious risk to infants and children. The agency today announced that OTC oral health products containing the pain reliever benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed and is asking companies to stop selling these products for such use. If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market. Also, the agency is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.
“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. We will also continue working with Congress to modernize our over-the-counter drug monograph regulatory framework as part of our mission to protect and promote public health.”
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