FDA to Pull OTC Oral Benzocaine Products Unless They Drop Teething From Labels

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.