FDA Issues Benzocaine Warning for Parents With Teething Babies
Benzocaine Puts Teething Babies At Risk
Got a teething baby?
Don’t give your baby anything that contains benzocaine!
According to the U.S. Food and Drug Administration,
“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, M.D.
“Because of the lack of efficacy for teething and the serious safety concerns we’ve seen with over-the-counter benzocaine oral health products, the FDA is taking steps to stop use of these products in young children and raise awareness of the risks associated with other uses of benzocaine oral health products.”
“In addition to our letters to companies who make these products, we urge parents, caregivers, and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain. We will also continue working with Congress to modernize our over-the-counter drug monograph regulatory framework as part of our mission to protect and promote public health.”
The FDA issued a formal announcement on May 23, 2018, in what is known as a “Drug Safety Communication.”
The announcement is warning consumers that over-the-counter (OTC) teething products containing benzocaine pose a serious risk to infants and children.
The announcement stated that OTC oral health products containing the pain reliever benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed and is asking companies to stop selling these products for such use.
If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market.
Also, the agency is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.
What Is Benzocaine?
Benzocaine is used for the temporary relief of sore gums due to teething in infants or children.
Benzocaine is either a prescription or OTC (over the counter) product marketed to help relieve pain from a variety of conditions, including:
- sore throat
- canker sores
- irritation of the mouth and gums
Products containing benzocaine are sold as gels, sprays, ointments, solutions, and lozenges.
This recent news announcement by the FDA is urging mothers with teething babies to stop using any product containing benzocaine for their teething baby.
The following brands have been named by the FDA as containing benzocaine:
- Baby Orajel
This warning also includes store brands and generic medications containing benzocaine.
Why Is Benzocaine Harmful to Teething Babies?
The FDA issued warnings about the risks associated with benzocaine products causing or contributing to a potentially fatal blood condition called methemoglobinemia.
Methemoglobinemia is a dangerous condition that is the result of elevated levels of methemoglobin in the blood, which causes the amount of oxygen carried through the blood to be greatly reduced.
The FDA made specific recommendations to manufacturers that use benzocaine in their products in order to protect patients and make sure the most up-to-date drug safety information will appear on drug labels.
“Given the accumulating evidence regarding benzocaine’s association with methemoglobinemia, we are taking necessary action to work with industry to discontinue the distribution and sale of over-the-counter benzocaine oral health products intended for teething pain, and add warning information about methemoglobinemia and a contraindication against use for teething pain and against use in children under two years of age to the remaining oral health care drug products containing benzocaine,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
“As part of the action, the agency is also requiring that prescription local anesthetics add updated warnings about their risk of this condition.”
Benzocaine Alteratives for Teething Babies
Teething is normal, we’ve all gone through it, and we don’t need to be medicating our kids in order to alleviate the discomfort of teething.
There are safer, non-toxic alternatives to ease the pain of a teething baby that don’t contain benzocaine.
According to the American Academy of Pediatrics (AAP), try gently rubbing or massaging the gums with one of your fingers.
Teething rings are helpful, too, but they should be made of firm rubber. (The teethers that you freeze tend to get too hard and can cause more harm than good.)
Pain relievers and medications that you rub on the gums are not necessary or useful to treat teething babies since they wash out of the baby’s mouth within minutes.
Stay away from teething tablets that contain the plant poison belladonna and gels with benzocaine.
Belladonna and benzocaine are marketed to numb your child’s teething pain, but given the recent FDA warnings, parents should avoid any products containing belladonna or benzocaine due to potentially harmful side effects.
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Editor’s Note: This post was originally published on Dental Patient News and has been republished here with permission. It has since been updated for accuracy & comprehensiveness.
Dr. Frank V. Maldonado on
Aug 2nd, 2018 10:05 am
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