July 31, 2014 — The consumer advocacy group Public Citizen is asking (PDF) the U.S. Food and Drug Administration (FDA) to issue stronger warnings about benzocaine and remove certain teething gels for infants due to the risk of a life-threatening side effect.
Benzocaine, a popular topical anesthetic, is associated with a rare but potentially deadly side effect known as methemoglobinemia. Since 2006, the FDA has received 29 reports of this side effect. Half of the cases occurred in children under two years old who were given over-the-counter teething gels.
The FDA published a warning, Benzocaine and Babies: Not a Good Mix, and told caregivers not to give teething gels with benzocaine to children under two. They specifically cited products like Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. Earlier this year, the FDA also warned against giving children lidocaine gel.
Public Citizen is concerned that these warnings are not sufficient. Although many products are advertised for teething infants, no clinical trials have been conducted and the FDA has never approved the products for this purpose.
Public Citizen was particularly concerned about nighttime teething gels. If complications occur, it is less likely that a caregiver will notice during the night. Even more troubling, some nighttime products contain even higher concentrations of benzocaine.
Both the FDA and the American Academy of Pediatrics recommend safer alternatives. For example, refrigerated teething rings, cold washcloths, bananas, and gently massaging the infant’s gums with your fingers can all help alleviate teething pain.
Symptoms of Methemoglobinemia
- pale, gray, or blue-colored skin, lips and nail beds
- shortness of breath
- fatigue
- confusion
- headache
- light-headedness
- rapid heart rate
Do I have a Teething Gel Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting teething gel induced injury cases in all 50 states. If you or somebody you know has been injured by benzocaine or methemoglobinemia, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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