Benzocaine Blood Disorder Prompts Warnings in U.S., Canada

<"">Benzocaine, the active ingredient in popular teething medications like Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase, has been the subject of safety warnings in the U.S. and Canada because of its association with a rare blood disorder called methemoglobinemia. According to both the U.S. Food & Drug Administration (FDA) and Health Canada, the disorder, which affects the amount of oxygen carried by the bloodstream, can be fatal.

The FDA first issued a warning about benzocaine and methemoglobinemia in 2006. But since then, the agency said it has received reports of 72 new cases of methemoglobinemia, including three resulting in death, associated with the use of benzocaine, bringing the total to 319 cases. Most of the cases have occurred in children aged two and under.

The FDA is warning that benzocaine products should not be used in children under two. Adults should also use these products with caution, and not more than four times per day.

Health Canada is continuing to evaluate the safety of benzocaine products in light of continued side effect reports. It has also warned parents about their association with methemoglobinemia.

According to Health Canada, other side effects associated with topical benzocaine products include breathing or swallowing difficulties, a swollen tongue or mouth, irregular heartbeat, malaise, body twitching, hypersensitivity, burning, redness, itching, rash and irritation at the site.

Symptoms of methemoglobinemia may include a pale, bluish or grayish pallor, shortness of breath, fatigue, confusion, and lightheadedness, and rapid heart rate. If any of these symptoms occur, medical attention should be sought immediately.

The symptoms of methemoglobinemia can appear in minutes or hours following the application of a benzocaine product. Often, the condition occurs after just one application of the medication, the FDA said.

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