FDA wants some teething medicines taken off shelves

HEALTH
               FDA says stop using over-the-counter benzocaine products on teething infants

Consumer-health companies must stop selling products such as Baby Orajel to parents with teething infants, US health regulators said, given the risk of developing a potentially deadly condition that reduces oxygen levels in the blood.

Over-the-counter products containing the anesthetic substance benzocaine are marketed to ease the pain of gums made sore by teething. Benzocaine can cause rare but deadly side effects in children, especially those two-years-old and younger.

More than 400 cases of benzocaine-associated methemoglobinemia have been reported to the FDA or in medical literature since 1971, according to a drug-safety communication the agency posted. The products are meant to temporarily alleviate pain in teething babies and children with sore gums. Rapid heart rate, headache, lightheadedness, difficulty in breathing, sleepiness, pale skin, and blue or gray eyes are some of the symptoms of methemoglobinemia.

The U.S. Food and Drug Administration (FDA) is warning consumers that some over-the-counter oral drug products should not be used to treat children under the age of 2. Educate families on the importance of reading the drug facts label to ensure products do not contain benzocaine. The FDA now says: stop right there. Manufacturers of prescription local anesthetics containing benzocaine must also include warning information regarding the risk of methemoglobinemia, and must respond to the FDA's letter within 30 days.

The FDA has asserted that if these product-manufacturing companies do not stop selling them, FDA will take strict actions against the companies to ban these products out of stores.

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They also warn against using homeopathic alternatives.

Examples of products include Baby Orajel, Little Teether's Oral Pain Relief Gel, and Anbesol Gels, along with their adult versions.

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

Dr. Lisa Thebner, a New York-based pediatrician, said parents still ask about the products with some frequency. "Rubbing their gum or giving them something hard, like a teething ring, it will be a much bigger help".

The FDA issued warnings about the teething products in 2006, 2011 and 2014, but it did not call for their removal from the market. Additionally, the agency is requesting that companies add new warnings to all other oral health products containing benzocaine to describe "certain serious risks". Signs and symptoms may occur after using benzocaine for the first time, or after prior uses and may appear within minutes to 1 to 2 hours after using benzocaine.

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