FDA Benzocaine Safety Alert Also Targets Pain From Public Citizen Complaint
This article was originally published in The Pink Sheet & The Rose Sheet
FDA is considering forcing off the market OTC benzocaine oral care products for treating infant teething pain, seven years after acknowledging the ingredient's link to a rare but potentially fatal condition, methemoglobinemia, and raising the possibility of requiring label changes.
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FDA is sued by Public Citizen after failing to make a decision on a 2014 citizen petition urging the agency to remove an infant teething indication for OTC benzocaine products. The complaint asks a federal court to order a response from the agency within 30 days.
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