FDA Wants Teething Products Made with Benzocaine Pulled from the Market

FDA Wants Teething Products Made with Benzocaine Pulled from the Market

FDA Wants Teething Products Made with Benzocaine Pulled from the Market

The Food and Drug Administration advises parents to stop using Orajel and other products marketed for teething babies containing benzocaine. The FDA is now urging companies to stop selling these benzocaine-containing products voluntarily. Oral products for adults to treat sore throats, canker sores and irritation of the mouth and gums can also contain benzocaine.

The FDA will continue to monitor the safety profile of these products and says they'll take action as necessary. Also, the agency is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

Benzocaine can lead to a rare but potentially fatal condition in young children called methemoglobinemia, which greatly reduces the amount of oxygen in the blood, the FDA stated. At the time, it estimated that there have been more than 400 cases of benzocaine-associated methemoglobinemia reported to the FDA or published in medical literature since 1971. You try every type of chilled teething toy you can get your hands on to relieve the pain in your baby's gums.

Wednesday's action comes more than four years after the consumer advocacy group Public Citizen petitioned the FDA to stop sales of teething products. It also repeated a previous warning to avoid homeopathic teething products, which may have a variety of possible side effects.

These new directives may have parents wondering - what are they supposed to do with a teething baby?

Benzocaine is marketed as a pain reliever for babies who are teething.

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One major manufacturer, Church and Dwight Co.

The agency said parents of teething children should follow advice from the American Academy of Pediatrics. Signs and symptoms of methemoglobinemia (which is a methemoglobin level above 10 percent) include shortness of breath, cyanosis, mental status changes, headache, fatigue, exercise intolerance, dizziness, and loss of hairlines.

Some brands that have benzocaine includes brands like Baby Orajel, Anbesol and Topex.

Regulators have warned about the dangers of benzocaine in the past, AP said. "Rubbing their gum or giving them something hard, like a teething ring, it will be a much bigger help".

Those concerned by the warning are advised to check if benzocaine is an active ingredient in products, and keep an eye out for symptoms of methemoglobinemia if they are used.

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