FDA warns of benzocaine-induced methemoglobinemia

February 20, 2006

Benzocaine sprays used for numbing the mouth and throat are being investigated by the FDA for their tendency to cause methemoglobinemia, a condition in which the red blood cells are unable to carry oxygen. Until recently, the FDA considered the incidence of methemoglobinemia with these products to be low; however, new reports have prompted the agency to review all available safety data.

FDA warns of benzocaine-induced methemoglobinemia

Benzocaine sprays used for numbing the mouth and throat are being investigated by the FDA for their tendency to cause methemoglobinemia, a condition in which the red blood cells are unable to carry oxygen. Until recently, the FDA considered the incidence of methemoglobinemia with these products to be low; however, new reports have prompted the agency to review all available safety data. The products will not be removed from the market until more information is gathered, but in the meantime, the FDA suggests that healthcare professionals consider not using the drug in patients with asthma, bronchitis, emphysema, or heart disease. In addition, patients who smoke, are under four months of age, have G-6-PD deficiency, hemoglobin-M disease, diaphorase 1 deficiency, or pyruvate-kinase deficiency may be candidates for other forms of therapy. Interestingly, the VA health system recently announced its decision to remove benzocaine sprays from its practice because it believes other topical anesthetics are less likely to cause methemoglobinemia. The FDA advisory pertains only to benzocaine sprays used in the mouth and throat and not to benzocaine sprays applied to the external skin. The products in question include Hurricane, Topex, and Cetacaine sprays.

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