The FDA is urging manufacturers to stop marketing oral OTC benzocaine products for teething and infants and children younger than 2 years of age. FDA also warns this is not just a problem with younger age groups. The product (which is both available for teething and oral spray product for adults) can trigger methemoglobinemia shortly after use and can lead to serious and life-threatening consequences
FDA is asking all manufacturers to review labeling to include warnings about the event as they continue to monitor the situation, and anticipates additional regulatory action due to the increasing reports of this rare but serious event. The safety alert provides alternative recommendations from the American Dental Association for teething pain. The notice states that “We [FDA] have been closely monitoring the risk of methemoglobinemia with the use of OTC and prescription local anesthetics and previously communicated about this risk in 2014, 2011, and 2006. We estimate that more than 400 cases of benzocaine-associated methemoglobinemia have been reported to FDA or published in the medical literature since 1971. There are likely additional cases about which we are unaware.”
FDA goes on to discuss the 4 reports of deaths and the 119 cases reported to FDA in an 8.5-year period. The full notice can be found here. The FDA initially warned of this issue back in 2011 and this update stresses the Agency’s increased concern about this serious adverse event.
