Anbesol, Orajel, Orabase Other Benzocaine Products Linked to Rare Blood Disorder, FDA Warns

U.S. health regulators warned today that <"">benzocaine liquids and gels used to treat mouth and gum pain, including Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase and store brands, have been associated with a potentially deadly complication called methemoglobinemia. The warning from the U.S. Food & Drug Administration (FDA) also applies to benzocaine sprays used during surgical procedures that are sold under the names 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. According to the FDA, it can result in death.

The agency first issued an alert about benzocaine sprays and methemoglobinemia in 2006. Since then, it has received reports of 72 new cases of methemoglobinemia, including three resulting in death, associated with the use of benzocaine sprays, bringing the total to 319 cases. The cases involving benzocaine gels and liquids occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething, the FDA said.

The side effect does not appear to be dose-related, the agency said. Many methemoglobinemia cases occurred after administration of a single benzocaine spray. The complication has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5%.

The FDA is advising that benzocaine products be kept out of reach of children, and they should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional. Adults who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label.

Symptoms of methemoglobinemia include pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. These signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use, the FDA said.

Benzocaine product labels do not currently contain a warning about their association with methemoglobinemia.

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