FDA Warns of Benzocaine Use in Younger Populations

Approximately six years ago, the U.S. Food and Drug Administration (FDA) was made aware of the potentially dangerous side effects linked to benzocaine treatment. Of significant concern, however, is the recent association that has been established between the topical treatment and a severe condition known as methemoglobinemia in younger populations. Since 2006, the FDA has received 29 reports of benzocaine gel-related cases of methemoglobinemia, many of which occurred in children under the age of two. Accordingly, the FDA has recently released a benzocaine warning intended to alert the public to these dangers.

Benzocaine is the active ingredient in a number of brand-name gels, lozenges, spray solutions and liquids that are intended to relieve minor pain and discomfort by blocking specific nerve signals in the body. Brand-name products like Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase, as well as store brands are used to treat oral complications caused by teething, canker sores, and irritation of the mouth and gums.

Unfortunately, the FDA notified healthcare professionals and patients that they continue to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat. The recent FDA Warning acknowledged that specific populations are more susceptible to the dangerous side effects associated with benzocaine.

Since the FDA first warned about potential dangers in 2006, the agency has received 29 reports of benzocaine gel-related cases of methemoglobinemia. Nineteen of those cases occurred in children, and 15 of the 19 cases occurred in children under 2 years of age, says FDA pharmacist Kellie Taylor, Pharm.D., MPH.

Methemoglobinemia, otherwise known as blue baby disorder as it pertains to infants, is a disorder characterized by the presence of a higher than normal level of methemoglobin in the blood. Methemoglobin is an oxidized form of hemoglobin that has a decreased affinity for oxygen, resulting in an increased affinity of oxygen to other heme sites and overall reduced ability to release oxygen to tissues. Subsequently, when methemoglobin concentration is elevated in red blood cells, children are at an increased risk of suffering from tissue hypoxia, shock, seizures and even death. Signs and symptoms of methemoglobinemia include:

  • Pale, gray, or blue-colored skin, lips and nail beds
  • Shortness of breath
  • Fatigue
  • Confusion
  • Headache
  • Light-headedness
  • Rapid heart rate

People with type 1 methemoglobinemia and hemoglobin disease usually do well. However, Type 2 methemoglobinemia is much more serious, and usually causes death within the first few years of life.

Due to the severity of this condition, the FDA has taken this opportunity to warn both the public and the healthcare community of the dangers associated with benzocaine treatment in children under two. For these reasons, FDA recommends that parents and caregivers not use benzocaine products for younger populations, except under the advice and supervision of a health care professional.

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