FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

SILVER SPRING, Md., May 23, 2018 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is warning consumers that over-the-counter (OTC) teething products containing benzocaine pose a serious risk to infants and children. The agency today announced that OTC oral health products containing the pain reliever benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed and is asking companies to stop selling these products for such use. If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market. Also, the agency is requesting that companies 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, M.D. "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. 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. We will also continue working with Congress to modernize our over-the-counter drug monograph regulatory framework as part of our mission to protect and promote public health."

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. The products are sold as gels, sprays, ointments, solutions and lozenges under the OTC brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store brands and generics. In a Drug Safety Communication issued today, the agency builds on its previous warnings about risks associated with benzocaine products for methemoglobinemia. This dangerous condition is the result of elevated levels of methemoglobin in the blood and it can lead to death. It causes the amount of oxygen carried through the blood to be greatly reduced. The FDA also outlined these safety concerns in letters that the agency sent to manufacturers of these products. The agency made specific recommendations to manufacturers in order to protect patients and make sure 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 two years of age to the remaining oral health care drug products containing benzocaine," said Janet Woodcock, M.D., 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."

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 advice on treating 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 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 FDA also previously cautioned parents and caregivers to not give certain homeopathic teething tablets to children and to seek advice from their health care professional for safe alternatives.

When buying OTC oral health drug products, consumers should refer to the OTC Drug Facts Label to see if benzocaine is an active ingredient and, if using these products, look for 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 1 to 2 hours after using benzocaine. These include pale, gray- or blue-colored skin, lips and nail beds; shortness of breath; fatigue; headache; lightheadedness; and rapid heart rate. If any of these symptoms occur after using benzocaine, the person should receive medical attention immediately. All drug products, including local anesthetics, should be stored out of reach of children.

The FDA urges consumers and health care professionals to report adverse reactions involving benzocaine or other medicines to the FDA's MedWatch program. The FDA will continue to monitor the safety of benzocaine products and will take additional actions as appropriate.

For more information:

• Drug Safety Communication: 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
• Safety Information on Benzocaine-Containing Products
• Consumer Update: Do Teething Babies Need Medicine on Their Gums? No
• Example Letter to Industry on Benzocaine
• Example Drug Facts Label

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, [email protected]
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

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