FDA Orders Benzocaine Teething Products Off Shelves For Deadly Methemoglobinemia Risk

FDA wants products containing Benzocaine removed.

The Food & Drug Administration posted a press release on its website today with the headline, “FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit.”

The headline was followed with, “Agency urges companies to discontinue teething products, include new warnings for other OTC benzocaine products and revise warnings for approved prescription local anesthetic drugs.”

What this means is over-the-counter teething products containing the pain reliever benzocaine pose a serious health risk to infants and children, and companies should stop selling them. The products are intended to temporarily alleviate pain in teething babies and children with sore gums.

The press release states that if companies do not comply, the FDA will initiate a regulatory action to remove these products from the market. Additionally, the agency is requesting that companies add new warnings to all other oral health products containing benzocaine to describe “certain serious risks.”

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