Over-the-counter teething gels containing a popular numbing agent pose a "serious risk" to babies and young children, federal health officials warned Wednesday (May 23).
The Food and Drug Administration says parents should stop using teething gels containing benzocaine to treat their children's teething issues as the medicine is not as effective as promised and can harm you.
Benzocaine gels and liquids are sold OTC under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands.
Manufacturers in the USA will have 30 days to update the product labels and "if companies do not comply, the FDA will initiate a regulatory action to remove these products from the market", the release states. New warnings will be added to products for adults.
Pharmacists can play an important role in postmarketing surveillance of benzocaine products by reporting methemoglobinemia cases to the FDA's MedWatch program.
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The specific problem cited Wednesday is methemoglobinemia, a condition that reduces the blood's oxygen-carrying capacity, potentially to life-threatening levels.
Church & Dwight Co., which sells and markets Orajel products for teething, said in a statement that the safety of its customers and their children is its highest priority, and it is immediately discontinuing the distribution and sale of Orajel teething products containing benzocaine.
FDA commissioner Scott Gottlieb said in a release there are "no demonstrated benefits" from the benzocaine products.
It's also not the first teething product that the FDA has cautioned against.
Signs and symptoms of methemoglobinemia include pale, gray, or blue-colored skin, lips, and nail beds; dyspnea; fatigue; confusion; headache; lightheadedness; and tachycardia. The AAP notes that pain relievers and medications that are rubbed on the gums for teething are not useful because they wash out of the baby's mouth within minutes and may present safety concerns. The American Academy of Pediatrics recommends that caregivers rub or massage the gums with their finger or use teething rings made of firm rubber. 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.