Home » FDA to Pull OTC Oral Benzocaine Products Unless They Drop Teething From Labels
FDA to Pull OTC Oral Benzocaine Products Unless They Drop Teething From Labels
Drugs Regulatory Affairs
In an alert that cited both safety and efficacy concerns, the FDA said it would pull over-the-counter oral benzocaine products from the market unless manufacturers discontinue their sale as teething products.
The agency also urged manufacturers to amend their labeling to include a warning about the risk of methemoglobinemia, a sometimes fatal condition that reduces the amount of oxygen in the blood.
The FDA logged 119 cases of benzocaine-associated methemoglobinemia between February 2009 and October 2017, including 11 in children under two. Four of the 119 patients died, including one infant.