FDA Demands Orajel to Soothe Teething Babies Be Taken Off Market

25 May, 2018, 20:59 | Author: Earnest Bishop
  • FDA Demands Orajel to Soothe Teething Babies Be Taken Off Market

Federal health officials in the USA warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers.

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.

"Due to the significant safety risk of methemoglobinemia, we have urged manufacturers that they should stop marketing over-the-counter oral drug products for treating teething in infants and children younger than 2 years".

Benzocaine is the active ingredient in several over-the-counter teething medications, including Anbesol, Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, and Topex.

If companies do not comply, the FDA threatened to remove the products from shelves, according to the agency's announcement. Products for adults can remain on the market but the FDA wants companies to add new warnings.

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Health officials have previously warned consumers about benzocaine, which can cause a rare but life-threatening blood condition, especially in children under age 2.

The crying echoes through your house - your teething baby is miserable, and all you are wishing for is some peace for the both of you. Now, it wants teething products off the market, noting there is little evidence they actually work.

It's also not the first teething product that the FDA has cautioned against. Instead, the group recommends giving babies teething rings or simply massaging their gums to relieve pain. Educate families on the importance of reading the drug facts label to ensure products do not contain benzocaine. Signs of methemoglobinemia include shortness of breath, fatigue, and pale, gray, or blue-colored skin, lips and nail beds.

Symptoms of methemoglobinemia can happen within minutes of using benzocaine.

In January 2017, the FDA warned against homeopathic teething tablets after finding "inconsistent amounts of belladonna" that sometimes far exceeded the amounts indicated on the label. The FDA will continue to monitor the safety of benzocaine products and will take additional actions as appropriate.



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