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FDA Warns Against Use of Certain Teething Products

Oral teething products that contain the ingredient benzocaine should not be used on children younger than two according to a recent FDA warning. The FDA warning states that these products have little to no benefit for children in this age group, though they are marketed to reduce teething pain. In addition, the active ingredient, benzocaine, may cause a life-threatening condition called methemoglobinemia, where the amount of oxygen carried through the blood is greatly reduced. The FDA issued a strong warning to manufacturers to stop marketing these products to consumers under two years of age. The recent warning stated that if companies fail to comply the FDA will take action to remove these products from the market.

The FDA has been closely monitoring the risk of methemoglobinemia with the use of OTC and prescription local anesthetics and issued communications three times in the past 12 years. Over 400 cases of benzocaine-associated methemoglobinemia have been reported to FDA or published in the medical literature since 1971.

OTC oral anesthetics are also not without risk for adults or children over two, and the FDA has mandated new warnings to be placed on product labels. The new labels will add a warning about methemoglobinemia; both the label and the directions for use will direct parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years. Consumers should look out for symptoms of methemoglobinemia if they continue to use oral benzocaine products to treat mouth pain. These include pale, gray or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and fast heart rate.

The warning statements notes that tried and true remedies such as teething rings or rubbing an infant’s gums are more effective than these OTC products which wash out of a baby’s mouth within minutes. For adults with mouth pain the FDA recommends salt water rinses or OTC pain medications.

 

Byline: Martha L. Sikes, MS, RPh, PA-C

Posted: June 4, 2018

Source: U.S. Food and Drug Administration
Adapted from the original article.

[Image: Oksana Kuzmina / Shutterstock]




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