Monday, 20 August, 2018

FDA Warns Against Using OTC Benzocaine Teething Products

The Food and Drug Administration said that various gels and creams containing the drug benzocaine can cause rare but deadly side effects in children especially those 2 years and younger Health officials warn of teething gel side effects
Carol Daniels | 25 May, 2018, 23:27

The U.S. Food and Drug Administration (FDA) warned parents not to use the common over-the-counter products that contain benzocaine agent for teething purposes.

Benzocaine is used in products to treat not just teething, but also sore throats, canker sores, and other oral irritations.

The FDA said it will take legal action against companies that don't voluntarily remove their products for young children. This warning highlighted the overuse of teething products containing benzocaine.

The agency has been warning about the products for a decade but said reports of illnesses and deaths have continued. Methemoglobinemia is a unsafe condition that results from elevated levels of methemoglobin, causing oxygen carried through the blood to be reduced, which can ultimately lead to death. Between 2009 and 2017 there have been 119 cases of the rare blood disorder associated with benzocaine including deaths of four babies associated with the use of benzocaine. You try every type of chilled teething toy you can get your hands on to relieve the pain in your baby's gums. The FDA now says: stop right there.

So if baby's teething, now what?

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Now they want these products completely off the market. 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. Pharmacists should advise patients experiencing any of these symptoms to seek emergency medical attention.

Pain relievers and medications that are rubbed on the gums for teething don't work because they wash out of a baby's mouth within minutes and may present safety concerns, the FDA said. The video warned parents about these risks, also urging them to avoid homeopathic teething products. "Teething rings are helpful, too, but they should be made of firm rubber".

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

"Here you have a product that doesn't really help and can induce harm", says Meeks.

"The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit", said FDA Commissioner Scott Gottlieb in a statement.

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