The FDA said that benzocaine can have a rare, but serious side effect on children, and especially those under 2 years old.
The products-sold under brand names like Orajel and Chloraseptic, as well as store brands and generics-are often used for relief from sore throats, canker sores and other oral irritations, according to the FDA.
The FDA will continue to monitor the safety profile of these products and says they'll take action as necessary. New warnings will be added to products for adults. The agency has been warning about the product for a decade but said reports of illnesses and deaths have continued.
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In children under two, benzocaine can cause a condition known as methemoglobinemia, where oxygen levels in the blood are abnormally low. Rapid heart rate, headache, lightheadedness, difficulty in breathing, sleepiness, pale skin, and blue or gray eyes are some of the symptoms of methemoglobinemia. The FDA has urged the makers of such remedies to stop the sales of such products.
As an alternative they write, "Try gently rubbing or massaging the gums with one of your fingers".
Inflammation from teething may also stimulate pain-causing nerves, so reducing inflammation may help relieve baby's pain.
The FDA expects manufactures to voluntarily remove their products as soon as possible.
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Symptoms of methemoglobinemia can happen within minutes of using benzocaine. The latest target? Children's gel teething products that contain the painkiller benzocaine.
The agency said parents of teething children should follow advice from the American Academy of Pediatrics.
Teething can be a hard time for infants.
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. 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. These products may remain on the shelves for adults say the FDA.
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