FDA Warns No Benzocaine for Teething Babies

Patient Care at TFC

On May 23, 2018, the FDA came out and said avoid using over-the-counter teething products containing benzocaine. That means no teething gels like Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel, Topex or other generic brands.

In general, most pediatricians think of teething as a developmental milestone, not a condition that demands medicine. Teething is a normal part of childhood and should not be treated with homeopathic remedies, like teething tablets, or prescription or over-the-counter (OTC) medications that are rubbed on the gums.

These products are not useful for treating sore gums due to teething because they wash out of a baby’s mouth within minutes. What’s more, they can be dangerous.

The use of benzocaine gels, sprays, ointments, solutions, and lozenges for mouth and gum pain can lead to a serious—and sometimes fatal—condition called methemoglobinemia, in which the oxygen-carrying capacity of red blood cells is greatly reduced.

What You Can Do for Teething Children

On average, children begin teething around 4 to 7 months, and have a total of 20 “baby teeth” by age 3.

According to the American Academy of Pediatrics (AAP), occasional symptoms of teething include mild irritability, a low-level fever, drooling, and an urge to chew on something hard.

Because teething happens during a time of much change in a baby’s life, it is often wrongly blamed for congestion, coughing, vomiting, diarrhea, and sleep disturbances.

If your child’s gums are swollen and tender:

• gently rub or massage the gums with your finger
• give your child a teething ring made of firm rubber to chew on

> Make sure the teething ring is not frozen.

> If the object is too hard, it can hurt your child’s gums.

> Parents should supervise their children so they don’t accidentally choke on the teething ring.

> Mom Tricks Blog Reviews 17 Best Non-Toxic Teething Toys Read More Here

Adults Can Be Affected Too (Yes Parents We Look Out for You Too!)

OTC benzocaine oral health care drug products are also widely used by adults. Doctors and dentists often use sprays containing benzocaine to numb the mucous membranes of the mouth and throat or to suppress the gag reflex during medical and surgical procedures, such as transesophageal echocardiograms, endoscopy, intubation, and feeding tube replacements. However, benzocaine sprays are not FDA-approved for these uses.

Talk to your health care professional about using benzocaine and other local anesthetics, especially if you have heart disease; are elderly; are a smoker; or have breathing problems such as asthma, bronchitis, or emphysema. Those conditions put you at greater risk for complications relating to methemoglobinemia.

Excerpt from the FDA Press Release May 23, 2018:

“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.”

That’s why the U.S. Food and Drug Administration (FDA) is warning parents and caregivers that benzocaine products should not be used to treat teething pain in infants or children.

As parents we just want our little ones to be comfortable.

But the last thing we want to do is reach for something that might cause harm in our babies, toddlers and children.

If you have ANY questions you may send a message in the Patient Portal and our Clinicians will respond Monday 830am to Friday 3pm.