FDA Issues Warning for Benzocaine Teething Remedies

FDA Issues Warning for Benzocaine Teething RemediesThe U.S. Food & Drug Administration (FDA) just issued a warning on some teething remedies such as Anbesol and Oragel. These topical pain relievers are typically rubbed on the gums of teething babies and can lead to a serious condition called methemoglobinemia, said MedPageToday. Methemoglobinemia can lead to oxygen deprivation, even death, in extreme cases, said the FDA.

The agency warning has to do with over-the-counter (OTC) toothache pain killers that contain benzocaine, according to FDA pharmacist Mary Ghods, RPH. The risk is most significant in children under the age of two, which is when most children teethe, noted MedPageToday.

The FDA issued its first warning on benzocaine teething products, which also include Hurricaine, Baby Orajel, and Orabase, in 2006, said MedPageToday. Since, the agency has received “29 reports of benzocaine gel-related cases of methemoglobinemia. Nineteen of those cases occurred in children, and 15 of the 19 cases occurred in children under 2 years of age,” said FDA pharmacist Kellie Taylor, PharmD, MPH. The agency’s second warning was issued a year ago, added Taylor, but the FDA is still worried over “the difficulty parents may have recognizing the signs and symptoms of methemoglobinemia when using these products at home,” she said, wrote WebPageToday.

Of concern is how the symptoms manifest because symptoms can appear within minutes of product application or hours later; children can become symptomatic with the first use or not until after several uses, said MedPageToday. Symptoms include pale, gray, or blue-colored skin, lips and nail beds; shortness of breath; fatigue; confusion; headache; light-headedness; and rapid heart rate.

The American Academy of Pediatrics (AAP) recommends using chilled teething rings instead of OTC benzocaine products or gently massaging the baby’s gums with a finger. If these less dangerous methods fail, the AAP suggests contacting a health care professional, said MedPageToday.

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

In its warning, the FDA noted its concerns over parents and caretakers not being able to readily recognize the signs and symptoms of methemoglobinemia linked to home use of OTC benzocaine products. Symptoms of methemoglobinemia may not always be evident or attributed to the condition.

The FDA advises parents and caregivers to not use OTC benzocaine products on children under two years of age, except under the advice and supervision of a healthcare professional. If a benzocaine product is used, it should be used sparingly and only when needed, and never more than  four times a day. A large list of benzocaine-containing OTC products is available on the FDA’s web site at: FDA: http://www.fda.gov/Drugs/DrugSafety/ucm250029.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=teething%20medication&utm_content=1.

Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5%, said the FDA, which also noted that labels of marketed benzocaine products do not yet contain warnings about the risk of methemoglobinemia, even though use of benzocaine can cause this serious condition.

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