FDA Warns of Problems from Benzocaine Products for Teething Pain

Federal health regulators are warning about a risk of serious problems from Baby Orajel, Orabase, Anbesol, Hurricaine and other over-the-counter products containing benzocaine, which are commonly used to smooth teething pain, but could cause children to develop a rare condition that may result in brain damage or death.

Benzocaine gels and liquids are commonly used by parents to help babies suffering from teething pain. However, use of the products in children under the age of two has been linked to a particularly high risk of developing a condition known as methemoglobinemia, in which the amount of oxygen carried through the blood stream is reduced.

In a consumer update posted May 31, the FDA indicates that children continue to develop this rare, but serious, condition after parents or caregivers use the over-the-counter teething pain remedies.

Since the FDA first warned about the problems with benzocaine products in 2006, at least 29 cases of methemoglobinemia have been linked to benzocaine gel. At least 19 of those cases involved children, and 15 were children under the age of 2.

The FDA recommends that parents not use Baby Orajel or other benzocaine products for children under two, unless they are specifically told to by their doctor. However, the prominent consumer watchdog Public Citizen has recommended that these products not be used at all, as there are alternative treatments for teething pain available, such as teething rings or massaging a child’s gums with a finger.

The current warning labels for over-the-counter benzocaine products are not required to carry a warning about the risk of methemoglobinemia side effects, which often require prompt admission to a hospital to reduce the risk of permanent injury or death.

Many parents have a difficult time recognizing the problems, so the FDA issued the consumer update to highlight the symptoms of methemoglobinemia from benzocaine products, which may include:

• Pale, gray or blue colored skin, lips and nail beds
• Shortness of breath
• Fatigue
• Confusion
• Headache
• Light-headedness
• Rapid heart rate

If symptoms develop, the FDA indicates that the products should be promptly stopped and the parent or caregiver should call 911. If left untreated, methemoglobinemia can result in serious side effects from the lack of oxygen in the blood, including seizures, developmental delays, mental retardation and, in severe cases, death.

Although children under the age of 2 are at a particularly high risk of methemoglobinemia from benzocaine, adults may also face a risk from benzocaine gels, liquids, sprays and lozenges, which are widely used. The FDA recommends that adults store any such products out of the reach of children, use only when needed and no more than 4 times a day.