Can Benzocaine be used in children?

No. The U.S. Food and Drug Administration (FDA) warns that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years of age. These products carry serious risks and offer little benefit for treating oral pain, including gum pain in infants due to teething. Most importantly, products containing benzocaine can cause methemoglobinemia, which can be life-threatening and lead to death.

Of the 21 reports of methemoglobinemia associated with the use of benzocaine gel or liquid products, 10 (47.6%) were classified as life-threatening and 6 (28.6%) were reported as serious. There was also one death reported, but it is unclear whether the use of benzocaine gel contributed to this outcome. Most of the cases involved pediatric patients, particularly children 2 years of age or younger, who received benzocaine gel for teething pain. However, it should also be noted that in 9 cases (42.9%), benzocaine products were overused or used against label recommendations (e.g. unsupervised self-administration or accidental ingestion of the gel by a child).

Indications

Benzocaine is a local anesthetic contained in some commercially available over-the-counter (OTC) oral drug products that is used to relieve pain from a variety of conditions, such as teething, mouth ulcers, sore throat, and irritation of the mouth and gums. It is typically administered orally as a lozenge or applied topically as a gel or spray. Benzocaine sprays are not FDA-approved for numbing the mucous membranes of the mouth and throat or for suppressing the gag reflex during minor medical and surgical procedures.

Side Effects

Methemoglobinemia is a serious and potentially fatal condition that can lead to a significant decrease in the amount of oxygen carried through the blood. Clinical manifestations include cyanosis, "chocolate-colored" blood, difficulty breathing, dizziness, fatigue, decreased oxygen saturation, and tachycardia. Symptoms usually develop within minutes to hours after benzocaine administration and may occur after the first application or after repeated applications. Methylene blue relieves symptoms in most cases and should be readily available in any area where benzocaine is regularly applied. Physicians should avoid using topical anesthetic sprays on inflamed or exposed mucosal surfaces because the rate and amount of absorption are unpredictable.

The development of methemoglobinemia after treatment with benzocaine sprays is not related to dose. Methemoglobinemia has been reported to occur after a single benzocaine spray and may also occur after the first or subsequent application of topical benzocaine preparations.

Contraindications

(1) Patients with respiratory problems such as asthma, bronchitis, or emphysema, patients with heart disease, and smokers are at greater risk for complications related to methemoglobinemia.

(2) Elderly patients and those with certain congenital defects such as glucose-6-phosphodiesterase deficiency, hemoglobin-M disease, NADH-methemoglobin reductase (diaphorase 1) deficiency, and pyruvate kinase deficiency may also be at greater risk for methemoglobinemia.

(3) Medications, foods, and water containing nitrites and nitrates may also induce methemoglobin formation, which would be additive to methemoglobin formed by benzocaine products.

References:

[1] ANKIT JAIN  Ian C H  Anuradha Patel. Benzocaine-Induced Cyanosis.[J]. Eplasty, 2016, 16: ic18.

[2] SHADLEY J. Methemoglobinemia and Benzocaine[J]. Gastroenterology Nursing, 1900, 80 1. DOI:10.1097/01.sga.0000296254.78457.3a.

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