Drug Safety and Availability > FDA Drug Safety Communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures

FDA Drug Safety Communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures


The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals that the Agency continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine sprays. These sprays are used during medical procedures to numb the mucous membranes of the mouth and throat.
Benzocaine sprays are marketed under different brand names such as Hurricaine, Cetacaine, Exactacain, and Topex.

Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. In some cases, symptoms of methemoglobinemia may not always be evident or attributed to the condition. The signs and symptoms usually appear within minutes to hours of using benzocaine. Conditions such as anemia, heart disease, and lung disease (e.g., emphysema) may exacerbate the toxicity of methemoglobinemia.

In 2006, FDA issued a Public Health Advisory warning about methemoglobinemia with the use of benzocaine sprays during medical procedures. Since then, FDA has received 72 new cases of methemoglobinemia, including three resulting in death, associated with the use of benzocaine sprays, bringing the total to 319 cases.

FDA is continuing to evaluate the safety of benzocaine (also see separate Drug Safety Communication on Benzocaine Gels and Liquids), and the Agency will update the public when it has additional information. FDA will take appropriate regulatory actions as warranted.


For more information, please visit: Benzocaine Sprays for Medical Procedures
Drug Safety and Availability > FDA Drug Safety Communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures


Drug Safety and Availability > FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth
Drug Safety and Availability > FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth