FDA Report: Benzocaine Sprays Associated With Methemoglobinemia

Methemoglobinemia may be associated with benzocaine sprays, according to a U.S. Food and Drug Administration report.

Benzocaine sprays are used to numb the mucous membranes of the mouth and throat in procedures such as transesophageal echocardiogram, endoscopy, bronchoscopy, intubation and feeding tube placements.

Methemoglobinemia is a reduction of oxygen in the blood stream, which in extreme cases can result in death. Signs of methemoglobinemia, including pale-, gray- or blue-colored skin, lips and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate, typically occur within minutes to one or two hours of using benzocaine.

Since the FDA issued a Public Health Advisory in 2006 about the association of methemoglobinemia with benzocaine sprays, 72 new cases of the condition have been reported. The amount of benzocaine used does not seem to affect the likeliness of contracting methemoglobinemia.

Although labels of benzocaine sprays are not required to warn about the risk of methemoglobinemia, the FDA is continuing to evaluate their safety.

Read the FDA report on the association of methemoglobinemia with benzocaine sprays.

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