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OTC benzocaine products pose rare but deadly risk

Consumer Reports News: April 08, 2011 05:08 PM

The Food and Drug Administration says it continues to get reports linking benzocaine, an ingredient in many over-the-counter drugs used to ease canker sores, irritated gums, and teething in children, with methemoglobinemia, a rare but potentially fatal condition. The risk appears greatest in young children.

Some products that include the ingredient are Cepacol Duel Relief Sore Throat spray, Lanacane spray, Solarcaine Medicate First Aid Spray, Benzocaine cream, Solarcaine lotion, Anbesol Maximum Strength liquid, and Cold Sore Therapy.

Methemoglobinemia can reduce the amount of oxygen carried in the blood, causing death in the most severe cases. Warning signs and symptoms include pale, gray or blue skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate.

The problem has been reported with all strengths of benzocaine gels and liquids. Cases occurred mostly in children two or younger who were teething. Symptoms usually appear within minutes to hours of applying benzocaine and can occur either with the first application, or after additional use. For spray, some cases of methemoglobinemia were reported following a single benzocaine spray.

If you use benzocaine topical products you should carefully follow the recommendations on the product label, and store it out of the reach of children. The products should not be used on children less than two years old, except under the supervision of a healthcare professional.

The FDA is continuing to evaluate the safety of benzocaine products, and wants health-care professionals and patients to report adverse side effects, or product quality problems to the MedWatch Safety Information and Adverse Event Reporting Program.

Download form or call 1-800-332-1088 to request a form.

Medwatch safety alert

Maggie Shader


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