FDA Warns Against Using OTC Benzocaine Teething Products

The FDA has issued a warning to patients to avoid using OTC benzocaine teething products due to the risk of a dangerous condition, methemoglobinemia.

The FDA has issued a warning to consumers to avoid using OTC benzocaine teething products due to the risk of methemoglobinemia. Methemoglobinemia is a dangerous condition that results from elevated levels of methemoglobin, causing oxygen carried through the blood to be reduced, which can ultimately lead to death.1 Pharmacists can play an important role in educating patients on the dangers of benzocaine teething products, and to recommend safe ways to relieve teething pain in infants and children.

Dangers of OTC Benzocaine Teething Products

The FDA warns that OTC benzocaine products should not be used to treat infants and children younger than 2 years of age, and can no longer be marketed for this population.2 Product brand names include Anbesol, Orabase, Orajel, Baby Orajel, Hurricane, and Topex.2 Additionally, benzocaine oral drug products should only be used in adults and children 2 years and older if they contain the following changes to the drug labels:2

  • Contains warning about methemoglobinemia
  • Includes contraindications instructing not to use for teething in infants and children younger than 2 years
  • Revises directions to not use in infants and children younger than 2 years of age

If manufacturers fail to comply, then the FDA will issue a regulatory action to remove these products from the market. Manufacturers of prescription local anesthetics containing benzocaine must also include warning information regarding the risk of methemoglobinemia, and must respond to the FDA’s letter within 30 days.2

Methemoglobinemia Cases

According to the FDA, there have been approximately 400 cases of benzocaine-associated methemoglobinemia, with 11 patients younger than 2 years of age.2 Additionally, 4 cases resulted in death including one infant and 3 adults.2

Signs and symptoms of methemoglobinemia include pale, gray, or blue-colored skin, lips, and nail beds; dyspnea; fatigue; confusion; headache; lightheadedness; and tachycardia. Pharmacists should advise patients experiencing any of these symptoms to seek emergency medical attention. Individuals at greatest risk of experiencing methemoglobinemia include patients with conditions such as asthma, bronchitis, emphysemia, and heart disease. Additionally, older adults, and smokers are at an increased risk of complications.

Pharmacists can play an important role in postmarketing surveillance of benzocaine products by reporting methemoglobinemia cases to the FDA’s MedWatch program.

Patient Counseling and Teething Recommendations

Pharmacists should educate parents to avoid using benzocaine, and other local anesthetics to treat teething pain in infants and children. The American Academy of Pediatrics recommends that caregivers rub or massage the gums with their finger or use teething rings made of firm rubber.3 Benzocaine products are not effective for teething since they wash out of the mouth within minutes. Educate families on the importance of reading the drug facts label to ensure products do not contain benzocaine. The OTC benzocaine products should only be used sparingly in adults, and children 2 years and older and not more than four times a day.

Homeopathic teething products should also be avoided, due to the risk of adverse effects. Additionally, pharmacists should educate patients on the signs and symptoms of methemoglobinemia.

References

  • U.S. Food and Drug Administration. FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit [news release]. Silver Spring, MD: May 23, 2018; FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm. Accessed May 23, 2018.
  • U.S. Food and Drug Administration. Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. FDA website. www.fda.gov/Drugs/DrugSafety/ucm608265.htm. Accessed May 23, 2018.
  • American Academy of Pediatrics. Teething: 4 to 7 months. AAP website. www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/Pages/Teething-4-to-7-Months.aspx. Accessed May 23, 2018.