FDA Warns Of Deadly Benzocaine Risks, Label Changes Might Be On The Way
This article was originally published in The Tan Sheet
Executive Summary
Concern that products with the painkiller benzocaine are linked to rare but serious and potentially fatal adverse events prompted an FDA consumer warning and could lead to label and package changes.
You may also be interested in...
FDA Benzocaine Safety Alert Also Targets Pain From Public Citizen Complaint
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.
FDA Benzocaine Safety Alert Also Targets Pain From Public Citizen Complaint
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.
Public Citizen Attempts To Force FDA Decision On Benzocaine Petition
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.