FDA Warns Against Use of OTC Benzocaine Products

The U.S. Food and Drug Administration (FDA) issued a warning earlier this week regarding the use of over-the-counter benzocaine teething products.  The FDA states that benzocaine oral drug products should only be used in adults and children over the age of two, and pose a serious safety risk for children under the age of two.

“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, MD in a press release. “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.

FDA is urging manufacturers to stop marketing OTC oral drug products for teething infants and children under 2 years of age, and to add warning labels to products intended for adults and children over two.  If manufacturers do not comply, the FDA will take action to remove the products from the market.

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