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FDA warns against using teething remedies for babies

25 May 2018

Over-the-counter teething medication with the drug benzocaine is a health risk for babies, according to the U.S. Food and Drug Administration.

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

The FDA said parents and caregivers should stop using the products and companies should stop selling them. It is also asking for new warnings on benzocaine products for adults.

Regulators have issued multiple warnings about benzocaine but deaths have continued.

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Benzocaine can cause a condition called methmoglobinemia, which can be deadly.

The traditional recommendation of a gentle massage with your fingers on your child's gums is the go-to treatment. Rapid heart rate, headache, lightheadedness, difficulty in breathing, sleepiness, pale skin, and blue or gray eyes are some of the symptoms of methemoglobinemia. She also says the Oragel products don't always work as advertised.

At present several gels and creams are being sold to parents of babies and toddlers who are teething.

In response to the FDA's warning, Church and Dwight Co. Inc., said Wednesday it would discontinue its four Orajel teething brands, including Baby Orajel and Orajel Medicated Teething Swabs.

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Over-the-counter products containing the anesthetic substance benzocaine are marketed to ease the pain of gums made sore by teething. However, the babies experiencing these problems should get medical attention immediately.

Out of 119 cases reviewed in detail, mostly involving adults (with the benzocaine-containing product most commonly used during transesophageal echocardiography), 36 reported methemoglobinemia levels of 30% to 55% - a normal level ranges from 1% to 2%.

"I have, for a while, cautioned against topical gels because of the danger, and babies are in the population at the highest risk for harm, and if you look at the risk versus benefit, it's not even all that helpful", said Dr. Lisa Thebner, a New York-based pediatrician.

The American Academy of Pediatrics has informed parents to use alternatives such as hard rubber teething products. Pharmacists can play an important role in educating patients on the dangers of benzocaine teething products, and to recommend safe ways to relieve teething pain in infants and children.

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FDA warns against using teething remedies for babies