FDA Benzocaine Warning: Benzocaine Dangerous to Children

On April 7, 2011 the FDA issued a warning about benzocaine, the active ingredient in oral pain medications such as Orajel, Anbesol, Orabase and Hurricaine. The FDA warns that benzocaine use has the potential to induce a potentially fatal side effect whereby the blood carries significantly lower amounts of oxygen. This condition, known as methemoglobinemia, can in rare cases cause death or brain injury and damage to the body tissues. The potential for life-threatening or long-term damages from methemoglobinemia due to benzocaine is further compounded in very young children. A recent examination of this potentially deadly danger has revealed that methemoglobinemia deaths have been misdiagnosed as SIDS. Furthermore, medical research has shown a link between over-the-counter benzocaine-based medications and methemoglobinemia.

No Current Warnings on Benzocaine Products - FDA Benzocaine Warning Cites Cause for Grave Concern

Benzocaine products do not currently contain warnings of methemoglobinemia, which the FDA stated as a grave cause for concern since consumers, parents and caregivers are in most likelihood not aware of this potential side effect and as such very unlikely to be monitoring for the possible side effect. Methemoglobinemia induced by benzocaine use may require treatment with medications and/or admission to a hospital. The FDA recommends that anyone experiencing pale, gray or blue colored skin lips and/or nail beds, shortness of breath, fatigue, confusion, headache, lightheadedness or rapid heartbeat after taking a medication with benzocaine such asOrajel, Anbesol, Orabase and Hurricaine immediately call 911. Benzocaine-induced methemoglobinemia may occur after the first application or even after using the medication multiple times without incident.

Products with Benzocaine Listed in FDA warning

The products listed below use benzocaine as their active ingredient, and the FDA has warned that they may cause methemoglobinemia: