FDA Issues Warning for Benzocaine Topical Products

Ottawa, ON: Health Canada is reminding Canadians, including parents and caregivers, about health risks associated with the use of topical benzocaine products, including a rare but potentially serious blood condition known as methemoglobinemia (MetHb). Health Canada continues to receive reports of benzocaine-related adverse reactions, including MetHb. We continue to evaluate the safety of benzocaine products in light of these reports and will take appropriate regulatory actions as warranted.

On April 7, the Food and Drug Administration (FDA) notified healthcare professionals and patients that it continues 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, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

Topical benzocaine products are available over-the-counter in various concentrations and formulations, including sprays, gels, liquids and creams, and are used to relieve pain from a variety of conditions such as sore throats, teething, toothache, canker sores, irritation of the mouth and gums, burns, insect bites, itching, and hemorrhoids. They are also used by healthcare practitioners during surgical, dental and other medical procedures to numb the mouth and throat.

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. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething.

The 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 development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.

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Last updated on Apr-19-11