Benzocaine-containing products sold over the counter to relieve babies' teething pain are too risky and should no longer be sold, the FDA said Wednesday. The agency on Wednesday said it wants manufacturers to stop selling products intended for babies and toddlers because the products contain a drug ingredient that can cause a rare but unsafe blood condition that interferes with normal breathing.
In addition, the FDA has asked manufacturers of OTC benzocaine-containing oral drug products to make changes to the labeling with regard to use in adults and children over the age of 2.
Benzocaine is used in products to treat not just teething, but also sore throats, canker sores, and other oral irritations. If this doesn't happen, the agency may use regulatory action to take the products off the market.
The agency has been warning about the products for a decade but said reports of illnesses and deaths have continued. This risky condition is the result of elevated levels of methemoglobin in the blood and it can lead to death.
Since 2009, 119 cases of benzocaine-associated methemoglobinemia have been reported to the FDA, 4 of which were fatal. Instead, the academy suggests trying teething rings made of firm rubber or massaging a child's gums. Symptoms include rapid heart rate, lightheadedness, difficulty breathing, sleepiness, headache, skin that is pale and nails that are blue or gray. The FDA also outlined these safety concerns in letters that the agency sent to manufacturers of these products. Inc., makers of this product based in New Jersey yesterday, they would stop the further production of the four different Orajel teething brands as well as Orajel Medicated Teething Swabs.
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FDA commissioner Scott Gottlieb said in a release there are "no demonstrated benefits" from the benzocaine products.
Some brands that have benzocaine includes brands like Baby Orajel, Anbesol and Topex.
The child can start showing symptoms of methemoglobinemia in few minutes after using these products. It also warns parents not to use homeopathic teething tablets and gels. Belladonna and benzocaine are marketed to numb your child's pain, but the FDA has issued warnings against both due to potential side effects.
Teething can be a hard time for infants.
Use of such products with benzocaine may lead to methemoglobinemia.