FDA Warns that Benzocaine and Babies are Not a Good Mix

June 5, 2012 — The FDA has issued a consumer update to inform parents about the risks of oral painkillers containing benzocaine.

The most popular products containing benzocaine include Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. The FDA is warning parents not to give these products to children under two years old due to the risk of methemoglobinemia, a life-threatening disease.

The FDA previously issued a warning about this risk back in 2006. The current publication seeks to update and inform consumers about the risk, because children continue to be injured by benzocaine teething gel products. Since 2006, there have been 29 reports of methemoglobinemia linked to benzocaine. Of these, 19 have occurred in children, most of whom were under 2 years old.

Methemoglobinemia is a blood disease that can occur when the blood produces too much methemoglobin. This substance is similar to hemoglobin, which is normally responsible for transporting oxygen in the blood, but methemoglobin cannot release oxygen. This disease can cause severe oxygen-deprivation in tissues, leading to tissue damage, brain damage, and death.

Symptoms of methemoglobinemia may include:

• Pale gray/bluish color to the skin, lips, nails
• Shortness of breath
• Fatigue
• Confusion
• Headache
• Light-headedness
• Rapid heart rate

Parents who notice these symptoms in a child who has been given benzocaine are advised to immediately stop using the product and call 911. Severe side effects can occur the first time benzocaine is given, but also in children who have never had a reaction to the product in the past. Therefore, no child under 2 years old should be given benzocaine without the direct guidance and supervision of a physician.

The FDA is recommending that parents seek other ways of alleviating a child’s discomfort during teething. This may include a special teething ring that has been chilled in the refrigerator. Parents may also try gently massaging the baby’s gums using a finger.

Benzocaine products can also adversely affect adults, though serious injury is more likely to occur in children. The FDA is warning that adults should never use benzocaine products more than four times in one day. Furthermore, if you are a smoker, have heart disease, breathing problems, asthma, bronchitis, or emphysema, talk to your doctor before using benzocaine.

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