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FDA Issues Warning About Benzocaine in Teething Medication

by The Kid's Doctor Staff

The U.S. Food and Drug Administration has issued a warning about over-the-counter (OTC) teething pain medicines that contain benzocaine, a local anesthetic and the active ingredient. The products are pain gels and liquid medications like Anbesol and Baby Orajel.

Benzocaine has been associated with a rare but serious condition called Methemoglobinemia, which reduces the amount of oxygen carried in the bloodstream and can result in death in the most severe cases. The FDA advises parents and caregivers not to use products with benzocaine on kids under 2, except under the advice and supervision of a healthcare professional.

There have been 21 cases of  methemoglobinemia reported in children and adults with all strengths of benzocaine gels and liquids. Methemoglobinemia has occurred mainly in children ages 2 or younger who were given the benzocaine gels to ease teething pain.

OTC benzocaine products come in the form of gels, sprays, liquids, and lozenges. Many OTC benzocaine products are sold under brand names listed on the FCA website.  Please note that there may be additional benzocaine products that are not listed. Consumers can look at the Drug Facts label when buying products used to treat pain in the mouth and gums to find out whether benzocaine is listed as the active ingredient.

Signs and Symptoms of Methemoglobinemia

Parents and caregivers using OTC benzocaine products on children should closely watch for signs and symptoms of methemoglobinemia. These may include:

- Pale, gray or blue colored skin, lips, and nail beds

- Shortness of breath

- Fatigue; confusion; headache

- Lightheadedness; and rapid heart rate

In some cases, symptoms of methemoglobinemia may not always be evident or attributed to the condition. Symptoms usually appear within minutes to one or two hours after using a benzocaine product, and methemoglobinemia can develop after using the product for the first time, as well as after several uses.

Methemoglobinemia caused by benzocaine may require treatment with medications and may require admission to a hospital. Serious cases of methemoglobinemia should be treated promptly. If left untreated or if treatment is delayed, serious cases of methemoglobinemia may cause permanent injury to the brain and body tissues, and even death, due to an inadequate supply of oxygen.

Parents and caregivers who suspect a child may have methemoglobinemia should stop using the product and seek medical help immediately by calling 911.

Alternatives to Benzocaine products

The American Academy of Pediatrics’ recommends the following for treating teething pain:

- Give the child a teething ring chilled in the refrigerator.

- Gently rub or massage the child’s gums with your finger to relieve the symptoms of teething in children.

If these methods do not provide relief from teething pain, consumers should contact a healthcare professional to identify other treatments.

Baby Orajel is now offering “Naturals Instant Teething Pain Relief” a gel that is benzocaine, alcohol, and dye-free.

The FDA offers a list of products containing benzocaine at http://www.fda.gov/Drugs/DrugSafety/ucm250029.htm

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