FDA issues Severe Health Warning against Using Teething Gels for Infants and Children

In a recent release the Food and Drug Administration (FDA) issued a stern warning regarding potential health risks associated with the use of many brand name teething gels like Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. The advisory, short of a product recall, is over concerns with the ingredient benzocaine used in the oral pain gels. Children under 2 years old appear to be at particular risk says the FDA.

Benzocaine is a local anesthetic found in the over-the-counter products like those previously listed in the gel and liquid pain relievers.

According to the FDA warning, the use of benzocaine gels and liquids for mouth and gum pain can lead to a rare but serious—and sometimes fatal—condition called methemoglobinemia. This is a disorder in which the amount of oxygen carried through the blood stream is greatly reduced. FDA pharmacist Mary Ghods, R.Ph. wanrs that, in the most severe cases, methemoglobinemia can result in death.

Methemoglobinemia caused by benzocaine may require treatment with medications and admission to a hospital. Serious cases should be treated right away. If left untreated or if treatment is delayed, methemoglobinemia may cause permanent injury to the brain and body tissues, and even death, from the insufficient amount of oxygen in the blood.

Twenty-nine reports of benzocaine gel-related cases of methemoglobinemia, mostly in children under the age of 2, have been reported in the last 6 years since the FDA made the initial warnings about benzocaine.

One reason for the urgent nature of the FDA warning is that parents may have trouble immediately recognizing the signs and symptoms of methemoglobinemia as the symptoms may not always be evident or attributed to the condition. As such, the FDA, “recommends that parents and caregivers not use benzocaine products for children younger than 2 years, except under the advice and supervision of a health care professional.”

Here are some of the dangerous warning signs and symptoms of methemoglobinemia:

pale, gray, or blue-colored skin, lips and nail beds
shortness of breath
fatigue
confusion
headache
light-headedness
rapid heart rate

“Symptoms can occur within minutes to hours after benzocaine use,” Ghods says. “They can occur after using the drug for the first time, as well as after several uses.” If your child has any of these symptoms after using benzocaine, she adds, stop using the product and seek medical help immediately by calling 911.

The FDA provided the following alternatives to oral gels and liquids for teething pain from the American Academy of Pediatrics:

– Give the child a teething ring chilled in the refrigerator.
– Gently rub or massage the child’s gums with your finger.
– If these remedies don’t provide relief, contact your health care professional for advice on other treatments.