In addition to Dr. Mellick’s outstanding video, please review the FDA’s Safety Information on Benzocaine-Containing Products and the chapter from the Internet Book Of Critical Care [Link is to TOC], Methemoglobinemia. October 2, 2021 by Dr. Josh Farkas
Dr. Mellick introduces the video:
Last week I was seeing a 7 month old infant referred for evaluation in the pediatric emergency department. The patient’s mother, a nurse, expressed concern about her baby and mentioned that her other child had died at 4 months from methemoglobinemia caused by a benzocaine containing teething medication. This occurred in a rural setting and due to lack of timely resources, the child succumbed from the methemoglobinemia. Her child’s death, she related, contributed significantly to the FDA’s 2018 ruling forbidding the use of benzocaine in teething products. Interestingly, in review the FDA letter on this topic, they mention the death of a 4 month old infant. In 2011 I filmed our treatment of another infant who had developed methemoglobinemia one to two hours after being treated with a benzocaine containing teething gel. It seemed fitting to update that video as well as spread the news about the current FDA position on the use of benzocaine in teething products for children under 2 years of age.
Please see Safety Information on Benzocaine-Containing Products from the FDA, current as of 6-25-2018. Here are excerpts:
Benzocaine is in many oral drug products currently used to relieve pain in the mouth and gums from a variety of conditions, or for numbing the throat or airway for medical procedures. Benzocaine oral drug products come in the form of gels, sprays, liquids, and lozenges. Benzocaine sprays are not FDA-approved to numb the mucous membranes of the mouth and throat, or to suppress the gag reflex during minor medical and surgical procedures.
Additionally, benzocaine is an active ingredient in non-oral over-the-counter (OTC) drug products, as well as prescription drug products used to treat other conditions, such as numbing pain on skin.
Benzocaine Safety Information
Benzocaine can cause a serious condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, is life-threatening and can result in death. Therefore, the FDA is warning that OTC oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. We are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug facts label. These products carry serious risks and provide little to no benefit for the treatment of oral pain including teething.
Due to the significant safety risk of methemoglobinemia, FDA notified makers of OTC benzocaine oral health products that they should stop marketing these products for treating teething in infants and children younger than 2 years. We have also urged manufacturers of OTC oral drug products containing benzocaine for adults and children 2 years and older to add to include a warning about methemoglobinemia, contraindications stating “do not use” in children under 2 years of age, and update directions for use stating “do not use” in children under 2 years of age on the drug facts label.
FDA is also requiring all prescription local anesthetics, such as lidocaine, to standardize warning information about methemoglobinemia in the prescribing information across this class of drug products.
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 (Drug Safety Communication, 5/23/18)
FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit (FDA Press Release, 5/23/18)
Example Drug Facts Label (PDF – 30KB) Please note the sample Drug Facts Labeling has been updated. The Allergy Alert warning was updated to be consistent with the OTC Oral Health Care Drug Products Tentative Final Monograph.
Do Teething Babies Need Medicine on Their Gums? No (Consumer Update, 5/23/18)
Teething Recommendations for Parents and CaregiversExternal Link Disclaimerdisclaimer icon by American Academy of Pediatrics (10/2016)
FDA urges consumers and health care professionals to report adverse reactions involving benzocaine or other medicines to the FDA’s MedWatch program.
FDA will continue to monitor the safety of benzocaine products and will take additional actions if needed.