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The FDA issued drug safety communications about a serious adverse effect associated with the use of over-the-counter (OTC) benzocaine gels, sprays, and liquids applied to the throat and gums to reduce pain.

In its communication to healthcare professionals, FDA is warning the public that the use of benzocaine is associated with methemoglobinemia, a rare but serious condition that results in the amount of oxygen carried through the blood stream being greatly reduced. In the most severe cases, methemoglobinemia can result in death.

Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5%. The cases occurred mainly in children aged 2 years or younger who were treated with benzocaine gel for teething.

FDA is particularly concerned about the use of OTC benzocaine products in children for relief of pain from teething because of the serious outcomes, including death, that may be associated with methemoglobinemia, as well as the difficulty parents or consumers may have in recognizing the signs and symptoms of methemoglobinemia when using these products at home.

Benzocaine gels and liquids are sold OTC under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands… full story.