The Food and Drug Administration (FDA) is warning customers that over the counter (OTC) teething products containing benzocaine pose a serious risk to infants and children. The agency also has announced that OTC oral health products with the pain reliever should no longer be marketed and is asking companies to stop selling them.
If companies don’t comply, the FDA will initiate regulatory action to remove these products from the market. Also, the FDA is asking companies to add new warnings to all other benzocaine oral health products to describe certain serious risks.
“The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit,” said FDA commissioner Scott Gottlieb, MD.
“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,” Gottlieb said.
“In addition to our letters to companies who make these products, we urge parents, caregivers, and retailers who sell them to heed our warnings and not use over the counter products containing benzocaine for teething pain,” Gottlieb said.
Benzocaine is marketed to help relieve pain from a variety of conditions such as teething, sore throat, canker sores, and irritation of the mouth and gums. Products are sold as gels, sprays, ointments, solutions, and lozenges under brand names such as Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel, and Topex, as well as store brands and generics.
In its Drug Safety Communication, the FDA builds on its previous warnings about the risks associated with benzocaine products for methemoglobinemia, which is the result of elevated methemoglobin in the blood and can lead to death. It greatly reduces the amount of oxygen carried in the blood.
The FDA also outlined these safety concerns in letters it sent to the manufacturers of these products. It made specific recommendations to manufacturers to protect patients and ensure the most up to date drug safety information will appear on drug labels.
“Given the accumulating evidence regarding benzocaine’s association with methemoglobinemia, we are taking necessary action to work with industry to discontinue the distribution and sale of over the counter benzocaine oral health products intended for teething pain and add warning information about methemoglobinemia and a contraindication against use for teething pain and against use in children under 2 years of age to the remaining oral healthcare drug products containing benzocaine,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
“As part of the action, the agency is also requiring that prescription local anesthetics add updated warnings about their risk of this condition,” Woodcock said.
The FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information about the risk of methemoglobinemia in product labeling across this class of products. Manufacturers of approved, prescription local anesthetics will have 30 days to reply to the FDA’s letter regarding these new Safety Labeling Changes.
For teething pain, the FDA recommends parents and caregivers follow the American Academy of Pediatrics’ (AAP) recommendations, which are to use a teething ring made of firm rubber (not frozen) or to gently rub or massage the child’s gums with a finger to relieve symptoms.
The AAP notes that pain relievers and medications rubbed on the gums aren’t useful because they wash out of the mouth within minutes and may present safety concerns. The FDA also previously cautioned against the use of certain homeopathic teething tablets and urged parents and caregivers to seek advice from their healthcare professional for safe alternatives.
The FDA encourages consumers to refer to the Drug Facts Label on over the counter oral health products to see if benzocaine is an active ingredient. Also, those who use these products should look for the signs and symptoms of methemoglobinemia.
Signs and symptoms may occur after using benzocaine for the first time or after prior uses and may appear within minutes to one to two hours after use. These include pale, gray, or blue skin, lips, and nail beds; shortness of breath; fatigue; headache; lightheadedness; and rapid heart rate. If any of these symptoms occur, seek medical attention immediately.
The FDA further urges consumers and healthcare professionals to report adverse reactions involving benzocaine or other medicines to the its MedWatch program. The FDA says it will continue to monitor the safety of benzocaine products and will take additional action as appropriate.