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Avoid Benzocaine for a Teething Baby, FDA Warns

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Avoid benzocaine for teething babies, the U.S. Food & Drug Administration (FDA) warns. According to the agency, benzocaine products should only be used to relieve teething pain in babies under the advice and supervision of a physician.

A local anesthetic, benzocaine is a fairly ubiquitous ingredient found in a number of over-the-counter (OTC) products including, Anbesol, Orajel, Baby Orajel, Orabase, and Hurricane noted Medical Xpress.

Although commonly available and purchasable without a prescription, benzocaine use in babies can lead to the rare, but potentially fatal methemoglobinemia, which can lead to oxygen deprivation, even death, in extreme cases, NewsInferno previously wrote. Because methemoglobinemia can significantly reduce the amount of oxygen carried through the bloodstream, it is a particular danger to children under the age of two, noted Medical Xpress, citing an agency news release.

The FDA has been issuing warnings about the dangers of benzocaine use since 2006. In that time, the agency has received 29 reports of benzocaine gel-related cases of methemoglobinemia; 19 in children and 15 in children under the age of 2, said Medical Xpress.

Parents may not always recognize the symptoms of methemoglobinemia, warns the FDA. How the symptoms manifest can be misleading, NewsInferno pointed out. Symptoms include pale, gray or blue-colored skin, lips and nail beds; shortness of breath; fatigue; confusion; headache; light-headedness; and rapid heart rate, said Medical Xpress. Symptoms can occur within anywhere from a few minutes to hours after use and can occur after the first time benzocaine is used, but can also appear for the first time after several uses. Methemoglobinemia symptoms may not always be evident or attributed to the condition, the FDA noted.

Should a child present with methemoglobinemia after being treated with benzocaine, parents and caretakers are advised to immediately call 911 (or the local emergency number outside the United States), said the FDA in its news release. The American Academy of Pediatrics suggests parents use chilled teething rings to relieve teething pain, or use a finger to gently massage the child’s gums. Should these less dangerous methods fail, the AAP suggests contacting a health care professional, said MedPageToday.

Although the FDA issued a second warning one year ago, FDA pharmacist Kellie Taylor, PharmD, MPH recently told MedPageToday that the agency is still worried over “the difficulty parents may have recognizing the signs and symptoms of methemoglobinemia when using these products at home.”

Benzocaine products are also sold in lozenge and liquid form and doctors and dentists use benzocaine sprays to numb the mouth and throat for medical procedures such as transesophageal echocardiograms, endoscopy, and feeding tube placements, said NewsInferno. For adult patients with heart disease, asthma, bronchitis, or emphysema, and for smokers, benzocaine products also present increased risks. Taylor recommends these adults discuss a preprocedure with their physicians.

Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5%, said the FDA. Labels of marketed benzocaine products do not yet contain warnings about the risk of methemoglobinemia, although benzocaine can cause this serious condition, the FDA added. A large list of benzocaine-containing OTC products is available on the FDA’s web site.

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