Over-the-counter benzocaine teething products, such as Orajel and Anbesol, may increase the risk of a fatal blood disorder, leading federal regulators to warn that they should not be used on infants or children under 2.
An FDA Safety Alert issued Wednesday, warning consumers not to use benzocaine oral products on young children. The agency also urges manufacturers to stop marketing the products as a treatment for teething infants under 2 years old.
Many popular products sold over-the-counter at stores nationwide contain the active ingredient benzocaine, including Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel, and Topex, as well as generic or store brand products.
Benzocaine is often used to relieve discomfort associated with teething and mouth pain. However, it is linked to a rare but serious and potentially fatal blood disorder called methemoglobinemia; a condition that reduces the oxygen carried through the blood. This can cause serious side effects or even death, especially among infants.
The FDA first warned about potential benzocaine problem in 2012. However, the agency has continued to receive reports of infants developing the rare blood condition. At least 29 cases of methemoglobinemia are linked to benzocaine gel products, including 19 cases involving children.
Consumer watchdog group Public Citizen filed a lawsuit against the FDA in 2017, after the agency failed to act on a petition calling for benzocaine to be limited in infant teething products.
The recent safety advisory indicates the FDA continues to receive reports of side effects.
The updated safety advisory the FDA warned benzocaine products, like Anbesol and Orajel, should not be used to treat infant and children under the age of 2. It should only be used on adults and children older than two.
In addition to recommending the products not be used on children under two years old, the FDA also calls on manufacturers to stop marketing OTC benzocaine oral products for treating teething in infants and young children. If companies fail to comply, the FDA indicated it will take action to remove the products from the market.
The FDA also urged manufacturers to make certain changes to the labels of benzocaine products. The labels should warn that the products were intended for use on adults and older children only, include a warning about methemoglobinemia, include contraindications warning parents the products shouldn’t be use for teething, and include revised directions to warn parents not to use the product on infants.
Federal regulator emphasized there are safer steps parents can take to help ease teething and mouth problems. Offering an infant a teething ring and massaging an infant’s gums with a finger can help relieve mouth pain.