The US Food and Drug Administration (FDA) has issued a warning to parents over the dangers of over-the-counter (OTC) teething products containing benzocaine when these oral health medications are administered to children.
The agency announced benzocaine-containing teething products will no longer be marketed and companies failing to comply could face regulatory action to remove their medications from the market. Furthermore, the FDA urged companies to include new warnings on all benzocaine oral health products to ensure consumers and physicians are aware of “certain serious risks”.
Benzocaine is used to relieve pain caused by a variety of different conditions and comes in several different forms, including gels, sprays, ointments, lozenges, and solutions. Among the OTC brands that contain the drug are Anbesol (benzocaine), Cepacol (benzocaine), and Orabase (benzocaine).
The reason for the latest recommendation is the risk of methemoglobinemia associated with benzocaine use. Methemoglobinemia is a potentially fatal condition and is the result of elevated levels of methemoglobin in the bloodstream, which causes a significant decrease in the amount of oxygen carried by the blood.
Signs of the condition may occur almost immediately after first use of benzocaine or any time within two hours on subsequent uses. Symptoms include pale, blue or gray-colored skin, lips and nail beds; shortness of breath; fatigue; headaches; lightheadedness; and a rapid heart rate. Should symptoms manifest, it is important that medical attention is sought immediately.
The FDA recommended parents follow the guidelines of the American Academy of Pediatrics’ (AAP) when treating teething pain in children. The AAP advises using a teething ring made of firm rubber, or gently massaging the child’s gums with a finger. The AAP explained topical teething pain-relieving medication is often ineffective as it is washed out of the baby’s mouth in minutes.
“Because of the lack of efficacy for teething and the serious safety concerns we’ve seen with over-the-counter benzocaine oral health products, the FDA is taking steps to stop use of these products in young children and raise awareness of the risks associated with other uses of benzocaine oral health products,” stated FDA Commissioner Scott Gottlieb, MD.
Parents, caregivers, and retailers were urged to take note of the warnings and discontinue use of OTC products containing benzocaine when treating teething pain.
In January 2018, the FDA announced a change to safety labelling requirements for prescription cough and cold medication containing codeine or hydrocodone, limiting use of these drugs to adults over the age of 18. The agency recommended using OTC products or medications that do not contain opioids when treating pediatric patients.
