Can I use orajel on my 4 month old

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If your baby is around 6 months of age and is keeping you up at night, they are probably experiencing teething pain. Classic signs of the impending arrival of new teeth include sore or tender gums, drooling, chewing on hard objects and irritability.

As a parent, you want to do whatever you can to help relieve the pain and soothe your baby. After all, a sleepless, cranky baby affects the whole family. Here are some tips to soothe sore gums:

  • Gently rub or massage the baby’s gums with your finger
  • Give the child a firm rubber teething ring chilled in the refrigerator
  • Offer a cold washcloth
  • If your baby eats solid food, try hard foods that your baby can gnaw on such as carrots or cucumber but beware of pieces that might break off and act as a choking hazard
  • Over the counter pain medications such as Tylenol or Motrin can be used

Do not give your child any medication that contains the pain reliever benzocaine. Benzocaine is a local anesthetic and can be found in such over-the-counter products as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. The use of benzocaine gels and liquids for mouth and gum pain can lead to a rare but serious—and sometimes fatal—condition called methemoglobinemia, a disorder in which the amount of oxygen carried through the blood stream is greatly reduced.

to read the full consumer update from the U.S. Food and Drug Administration.

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Twenty-seven years after the US Food and Drug Administration (FDA) approved a mild oral painkiller for over-the-counter use, the agency is reversing its stance.

On May 22, the FDA issued a warning about over-the-counter products containing benzocaine, citing “serious safety concerns” and a “lack of efficacy for teething.” The painkiller can be found in Baby Orajel, a gel that can be spread over the gums, as well as in other sprays, gels, and lozenges.

In children under two, benzocaine can cause a condition known as methemoglobinemia, where oxygen levels in the blood are abnormally low. Symptoms include a gray or bluish appearance, especially in the lips and nail beds, as well as rapid breathing and an elevated heart rate. They can occur a couple of minutes to several hours after receiving a dose of a product containing benzocaine. In some cases, methemoglobinemia can be fatal.

The FDA’s warning is an update to a statement the regulatory agency made seven years ago. At that time, the FDA was aware that methemoglobinemia was a rare reaction to benzocaine; it had received a total of 319 reports of this particular complication, not limited to children. Seventy-two of them occurred between 2006 and 2011. In that statement, the FDA said it planned to monitor benzocaine products, and would update advisories as needed.

In addition to warning consumers this week, the FDA sent a letter (pdf) to companies that sell these products, request that they discontinue any lines marketed for teething relief. According to the letter, benzocaine products marketed to adults—including Orajel, Anbesol, Cepacol, and Chloraseptic—are still considered safe, but need to contain two additional warnings: one telling users that the product shouldn’t be used for children under two, or for teething, and another about the risks of methemoglobinemia.

Even before the latest warning, the American Academy of Pediatrics did not endorse these types of teething painkillers. Tiny baby bodies can easily swallow too much of a particular painkilling gel, it says. It’s better to give your child a rubber teething ring or a gentle finger massage (frozen toys have been known to also cause oral injuries).

Alice Langford, Rebecca Gaines and Anna E. Mazzucco, PhD, National Center for Health Research

Teething is the appearance of an infant’s first set of teeth (or “baby teeth”). This process can begin as early as three months of age, and may not be complete until the child is three years old. Although some children may not be affected by teething, others may show signs of discomfort such as fussiness, trouble sleeping, loss of appetite, and excessive drooling. For these reasons, the teething period can be challenging for children and their parents!

Teething can last for months and has the same symptoms as other infant challenges, making it tough to know for sure what is bothering the child. The American Dental Association does not consider fever, diarrhea, or rashes to be signs of teething. One simple way to identify teething is to gently feel your child’s gums for swollen areas or an emerging tooth. If in doubt, and your child seems uncomfortable, you can always check with your pediatrician.

If your child is teething, it can be tough to sort through all the children’s products on the market. Here are some tips on how to make teething as safe and comfortable as possible.

Just Say No to Orajel (Benzocaine) for Teething

Many parents reach for Orajel or Baby Orajel, which are teething gels that contain benzocaine and are designed to soothe sore gums. Benzocaine products have been used for years, but in May 2018, the FDA declared that over-the-counter (OTC) benzocaine products are a serious risk to children and infants and said that these products should be taken off the market. They warned parents that benzocaine should not be used on infants and young children to soothe teething pain. The FDA is taking action against the use of benzocaine products because they have the potential to cause a condition called methemoglobinemia.

Methemoglobinemia is a potentially deadly condition that causes blood to carry less oxygen. Signs of methemoglobinemia may show either minutes or 1-2 hours after the use of lidocaine products. Symptoms include:

  • Pale, gray, or blue-colored skin, lips and nail beds
  • Trouble breathing
  • Tiredness
  • Headache
  • Lightheadedness
  • Racing heartbeat

If any of these symptoms appear after the use of benzocaine products, seek immediate medical care. Products that contain benzocaine include: Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex.

Lidocaine and Other Medications for Relieving Teething Pain? Proceed with Caution.

Are there any other medications for teething? Some parents have used topical lidocaine to numb their child’s gums. However, in June 2014, the Food and Drug Administration (FDA) warned parents that lidocaine should not be used on infants and young children to soothe teething pain.

The FDA now requires a black box warning, which is the FDA’s most serious warning, for lidocaine solution. Lidocaine is a common painkiller that the FDA has never approved to treat teething pain but that parents sometimes used. The FDA now realizes that the risks of lidocaine are greater than its benefits for young children. The agency has received 22 reports of “serious adverse reactions,” including six deaths and 11 hospital admissions.

Why is lidocaine dangerous, and why did it take so many years to realize it? The answer is simple: It is too easy for an adult or child taking care of an infant to give too much lidocaine, which can cause seizures, brain injury, or heart problems.

What about more traditional pain medication? Most experts believe that teething should not require medication, but some doctors may advise using a very low dose of acetaminophen (Tylenot) or ibuprofen (Advil) to relieve teething discomfort. Be sure to ask your child’s doctor before deciding to use any medication for teething. And, be sure to measure any medications very carefully, and don’t use them often, because infants can be harmed even by “over the counter” medications. Products containing aspirin should never be given to children unless instructed by your healthcare provider.

What Can I Do to Help with Teething?

Fortunately, there are safe, non-toxic ways to treat teething. A simple do-it-yourself option is to wet one end of a washcloth or burp cloth and briefly freeze it before offering it to your baby to chew on. Commercial cloth products using natural fabrics are also available, including organic cotton varieties.

If a baby has started eating solid foods, offering a chilled puree or yogurt (as appropriate) can offer relief. For an added bonus, refrigerate the spoon first. If a child is old enough for a sippy cup, you can also serve them cool water to ease the pain.

The American Academy of Pediatrics (AAP) also suggests using clean fingers to gently massage gums, or using a chilled teething ring. However, there are safety concerns about plastic teething rings. A 2015 study found endocrine-disrupting chemicals, which can affect the child’s hormones, in several types of plastic baby teethers. For this reason, it makes sense to avoid using teethers.

The Bottom Line

Teething pain should not require medical treatment. If your child is experiencing extreme pain or has a high fever, teething is probably not the cause and you should contact a medical professional. Additionally, don’t assume that products sold in your local drug store or online are safe.

Simple teething pain relief methods such as massaging the gums or offering a chilled washcloth, food, or water are effective home remedies which don’t rely on teethers. And a final thing to keep in mind: Teething children may also stick other objects in their mouths in an effort to soothe their gums themselves, so watch out for potential choking hazards!

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

Orajel

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)
Brand Names: Orajel

Medically reviewed by Drugs.com. Last updated on Jun 24, 2019.

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What is Orajel?

Orajel contains benzocaine, a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Orajel numbs the skin or surfaces inside the mouth and used for the temporary relief of pain from sore throat, canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums.

Orajel is also use for temporary relief of sore gums due to teething in children 2 years of age and older.

Important Information

Orajel used in the mouth may cause a condition in which the oxygen in your body tissues can become dangerously low. This is a potentially fatal condition called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a). Do not use this medicine if you have ever had methemoglobinemia.

GET EMERGENCY MEDICAL HELP IF YOU HAVE SYMPTOMS OF METHEMOGLOBINEMIA: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

An overdose of benzocaine can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. Use the smallest amount needed.

Do not use Orajel on a child younger than 2 years old.

Before taking this medicine

Do not use Orajel if you have ever had methemoglobinemia in the past.

Do not use Orajel on a child younger than 2 years old.

An overdose of benzocaine can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This can happen if you apply more than the recommended dose.

Ask a doctor or pharmacist if this medicine is safe to use if you have:

  • a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency;

  • asthma, bronchitis, emphysema, or other breathing disorder;

  • heart disease; or

  • if you smoke.

Ask a doctor before using Orajel if you are pregnant or breast-feeding.

If you apply Orajel to your chest, avoid areas that may come into contact with the baby’s mouth.

How should I use Orajel?

Use Orajel exactly as directed on the label, or as prescribed by your doctor. Read all medication guides or instruction sheets.

Your body may absorb more benzocaine if you use too much, if you apply it over large skin areas.

Use the smallest amount needed to numb the skin or relieve pain. Do not use large amounts of Orajel. Do not cover treated skin areas with plastic wrap without medical advice.

Do not use Orajel to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using Orajel. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since Orajel is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while using Orajel?

Avoid eating within 1 hour after using Orajel on your gums or inside your mouth.

Avoid getting Orajel in your eyes. Avoid swallowing the gel while applying it to your gums or the inside of your mouth.

Orajel side effects

Orajel used in the mouth may cause a condition in which the oxygen in your body tissues can become dangerously low. This is a potentially fatal condition called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a). This condition may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using Orajel in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

  • a headache, tiredness, confusion;

  • fast heartbeats;

  • feeling light-headed or short of breath; and

  • pale, blue, or gray appearance of your skin, lips, or fingernails.

Get emergency medical help if you have signs of an allergic reaction to Orajel: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • severe burning, stinging, or sensitivity where the medicine is applied;

  • swelling, warmth, or redness; or

  • oozing, blistering, or any signs of infection.

Common Orajel side effects may include:

  • mild stinging, burning, or itching where the medicine is applied;

  • skin tenderness or redness; or

  • dry white flakes where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Orajel?

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Orajel only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 7.01.

Medical Disclaimer

More about Orajel (benzocaine topical)

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Clearly not all parents who’ve used this product have experienced something similar, but Kapetanovic says many have reached out to say they were unaware of these risks when they did. “The product is not properly labeled and is being advertised to a target market that it’s not intended for,” she states. “As a result of this, it’s easy to misuse. I don’t want any other parent, or baby for that matter, to go through what I went through with Chloe.”

Now that nearly 100,000 people have shared her post, Kapetanovic hopes that the power of social media will help raise awareness about benzocaine and its potential effects. “My goal in sharing Chloe’s story is to draw attention to the defective advertising,” she says, “as well as make parents aware of the risk they’re taking by using this product so they can do their own research to determine if they feel it’s worth the risk or not.”

Update, March 15, 2018: Target reached out to GoodHousekeeping.com to state that the product information for Orajel Nighttime Teething Gel on its website now reflects the recommended ages consistent with the guidelines on the packaging.

Related Stories Caroline Picard Health Editor Caroline is the Health Editor at GoodHousekeeping.com covering nutrition, fitness, wellness, and other lifestyle news.

Federal health officials warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers. At least one major manufacturer announced that it will pull its teething gel for infants off the market.

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.

The agency has been warning about the products for a decade but said reports of illnesses and deaths have continued. Now, it wants teething products off the market, noting there is little evidence they actually work.

“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,” said FDA Commissioner Scott Gottlieb, in a statement.

The FDA said it will take legal action against companies that don’t voluntarily remove their products for young children. Manufacturers are expected to comply as soon as possible.

The agency posted a video on YouTube entitled, “Do teething babies need medicine on their gums? No.” It urged parents to avoid the products because of the risk of a potentially life-threatening condition called methemoglobinemia, which reduces oxygen in the blood. It also repeated a previous warning to avoid homeopathic teething products, which may have a variety of possible side effects.

Do Teething Babies Need Medicine on Their Gums? No by USFoodandDrugAdmin on YouTube

Benzocaine is also used in popular over-the-counter products for toothaches and cold sores in adults, including Orajel and Anbesol and generic drugstore brands. Products for adults can remain on the market but the FDA wants companies to add new warnings.

Benzocaine can cause a rare blood condition linked to potentially deadly breathing problems. The pain-relieving ingredient can interfere with an oxygen-carrying protein in the blood. Symptoms include shortness of breath, headache and rapid heart rate.

The maker of Orajel said it would discontinue products for infant teething pain. Amazon.com

Teething products with benzocaine include Baby Orajel. The packaging states: “Instant relief for teething pain.”

New Jersey-based manufacturer Church and Dwight Co. Inc. said Wednesday it would discontinue four Orajel teething brands, including Orajel Medicated Teething Swabs.

“We are not discontinuing other Orajel products, which represent the majority of our Orajel offering,” the company said in an emailed statement.

The American Academy of Pediatrics does not recommend teething creams because they usually wash out of the baby’s mouth within minutes. Instead, the group recommends giving babies teething rings or simply massaging their gums to relieve pain.

The FDA issued warnings about the teething products in 2006, 2011 and 2014, but it did not call for their removal from the market. Officials reviewed 119 cases of the blood disorder linked to benzocaine between 2009 and 2017, including four deaths, according to the FDA.

FDA warns teething medicines unsafe for children, wants them off shelves

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WASHINGTON — Federal health officials warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers.

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.

The agency has been warning about the products for a decade but said reports of illnesses and deaths have continued. Now, it wants teething products off the market, noting there is little evidence they actually work.

“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,” said FDA Commissioner Scott Gottlieb, in a statement.

The FDA said it will take legal action against companies that don’t voluntarily remove their products for young children. Manufacturers are expected to comply as soon as possible.

Benzocaine is also used in popular over-the-counter products for toothaches and cold sores in adults, including Orajel and Anbesol and generic drugstore brands. Products for adults can remain on the market but the FDA wants companies to add new warnings.

More: FDA says stop using over-the-counter benzocaine products on teething infants

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Benzocaine can cause a rare blood condition linked to potentially deadly breathing problems. The pain-relieving ingredient can interfere with an oxygen-carrying protein in the blood. Symptoms include shortness of breath, headache and rapid heart rate.

Teething products with benzocaine include Baby Orajel. The packaging states: “Instant relief for teething pain.”

New Jersey-based manufacturer Church and Dwight Co. Inc. said Wednesday it would discontinue four Orajel teething brands, including Orajel Medicated Teething Swabs.

“We are not discontinuing other Orajel products, which represent the majority of our Orajel offering,” the company said in an emailed statement.

The American Academy of Pediatrics does not recommend teething creams because they usually wash out of the baby’s mouth within minutes. Instead, the group recommends giving babies teething rings or simply massaging their gums to relieve pain.

The FDA issued warnings about the teething products in 2006, 2011 and 2014, but it did not call for their removal from the market. Officials reviewed 119 cases of the blood disorder linked to benzocaine between 2009 and 2017, including four deaths, according to the FDA.

The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

FDA Says Beware Of Baby Teething Products With Benzocaine

The US Food and Drug Administration is warning parents about potentially deadly risks of teething… remedies that contain a numbing ingredient used in popular brands like Orajel. 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 dangerous blood condition that interferes with normal breathing. (AP Photo/Stephanie Nano)

Death will take care of your infant’s teething pain. But there’s a slight problem with death.

The U.S. Food and Drug Administration has issued a warning about over-the-counter (OTC) teething products that contain benzocaine. By teething products, they don’t mean products that create more teeth in infants (which would be quite weird) but products marketed to relieve pain associated with teeth emerging through the gums. Gels, sprays, ointments, solutions and lozenges that go by names such as Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex can have benzocaine in them. Benzocaine is a topical anesthetic, a substance that numbs mucous membranes. That’s why some people use benzocaine for sore throats, canker sores and other types of mouth and gum irritation.

Here’s a problem though. Benzocaine can lead to a condition called methemoglobinemia, especially in children under 2 years of age. The exact risk is unclear, but it is a possibility. (Also, there’s no word on the risk for adults under 2 years of age, or children over 25 years of age.)

What is methemoglobinemia besides a good Scrabble word? Hemoglobin is a protein in red blood cells that serves as the Uber or Lyft for oxygen. Red blood cells containing hemoglobin pick up oxygen molecules in the lungs (the hemoglobin is like the seat in the Uber or Lyft), travel through your blood vessels to different locations, and then drop off the oxygen molecules at various body tissues. Methemoglobin is a form of hemoglobin that can pick up but cannot release oxygen. An Uber or Lyft that picks you up but never lets you get off would be a bad one to take. Similarly, too high levels of methemoglobin are bad for your body. Your body tissues will end up being starved of oxygen. And as the Oxygen Channel may tell you, you can’t survive without oxygen. Thus, methemoglobinemia, which is an abnormal amount of methemoglobin in your red blood cells, can result in shock, seizures, and even death.

Thus, if your baby turns blue (and isn’t Mystique or a character on Avatar) after getting a product with benzocaine (even just a squirt), be concerned. Other potential symptoms of methemoglobinemia include headache, fatigue, shortness of breath, or lack of energy. If the methemoglobinemia, is mild, the infant may be able to get by without treatment. But call your doctor immediately if there is any suspicion of methemoglobinemia. There are treatments such as methylene blue, ascorbic acid, hyperbaric oxygen therapy, red blood cell transfusion and exchange transfusions.

Therefore, the FDA is warning customers to stop buying teething products with benzocaine and companies to stop selling them for that use. Here’s a video from the FDA that basically says “stop it”:

As FDA Commissioner Scott Gottlieb, M.D. said in the press release:

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.

“Lack of efficacy” is a scientific way of saying “it don’t work.” Even if benzocaine is able to numb the gums, babies may end up swallowing or spitting out the product rendering it useless, because that’s what babies do, spit, drool, gurgle, and other fun stuff. Do you really want to give your baby something that may not work and has a chance of killing your baby?

Your answer should be “like baby, baby, baby no,” in the words of Justin Bieber. Instead, stick to natural ways of dealing with teething pain. And natural does not mean naturopathic. I have written before for Forbes about how some “natural” teething products can have bad stuff such as belladonna. Keep in mind that dirt and poop are “natural” too. In this case, natural means like applying a cool washcloth, using a teething ring, rubbing your baby’s gums, or changing your baby’s food (sorry no more rib eye steaks or surf and turf for baby).

If you have a teething baby on your hands, you’ve probably heard that remedies such as Orajel can help. But is Orajel safe? Turns out, Orajel and other teething products contain a potentially dangerous drug called benzocaine, which can cause rare but deadly side effects in children, according to the Food and Drug Administation (FDA). Now, the FDA wants these types of teething meds off the shelves entirely.

“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,” said FDA commissioner Scott Gottlieb, MD, in a statement.

At least one major manufacturer, Church and Dwight Co. Inc., already said it would discontinue four Orajel teething brands, including Baby Orajel and Orajel Medicated Teething Swabs. Meanwhile, the FDA said it would take legal action against other companies that didn’t follow their instructions to remove these types of products from stores as soon as possible.

The agency has been warning about these products for more than a decade, but said that reports of illness and death have continued. And even if kids don’t react, there is little evidence that the meds even help them with teething pain in the first place.

One Mom’s Scary Experience With Orajel

Mom-of-two Danielle Kapetanovic knows the horror of accidentally putting her child’s health at risk with Orajel all too well. In February 2018, she publicly shared her experience on Facebook so no mother would have to go through what she did.

In hopes of easing her sweet 15-month-old baby’s sore gums, Kapetanovic explained decided to purchase an over-the-counter nighttime teething gel with a picture of a baby on the packaging. Little did she know that applying just a “pea-size” amount of the gel to her daughter’s gums would cause her daughter, Chloe, to stop breathing.

“Chloe immediately turned red, started kicking, got one or two screams in, and 10-15 seconds after the Orajel touched her gums she became unresponsive,” Kapetanovic wrote. “Her eyes locked in a dead stare, she became limp and stopped breathing. She turned blue.”

Kapetanovic said she began doing CPR on Chloe while her husband called 911.

“Thankfully, she woke up and started screaming and crying after maybe 15-20 seconds in total, which felt like an eternity,” Kapetanovic wrote. “The ambulance arrived and EMTs checked her out and determined she was okay.”

Although little Chloe was ultimately okay, her doctors still aren’t sure if what happened to her was a reaction to benzocaine — the active ingredient in Orajel — or a “breath-holding spell.” And as Kapetanovic later learned, the FDA was already advising against using Orajel on children under age two, despite the image of a baby on the packaging.

Why is benzocaine so dangerous?

Back in 2006, the Food and Drug Administration (FDA) released a warning about the potential dangers of products containing benzocaine — a local anesthetic used in Baby Orajel, Orajel, Orabase, Anbesol, and other topical pain relievers. The warning came after the agency received an upsetting number of benzocaine gel-related cases of methemoglobinemia — a rare but serious condition that reduces the amount of oxygen in the bloodstream — 15 of which occurred in children under two. The FDA released yet another warning in April 2011, urging parents to refrain from giving children under two products that contain benzocaine, unless under the advice and supervision of a health care professional.

According to the FDA, danger signs of methemoglobinemia include:

  • pale, gray, or blue-colored lips, skin, and nail beds
  • fatigue
  • confusion
  • shortness of breath
  • headache
  • rapid heart rate

“Symptoms can occur within minutes to hours after benzocaine use,” FDA pharmacist Mary Ghods, R.Ph., said in a statement. “They can occur after using the drug for the first time, as well as after several uses.”

If your baby is experiencing any of these symptoms after using benzocaine, Ghods recommends seeking medical attention immediately by calling 911. If left untreated, methemoglobinemia can lead to permanent injury to the brain and body tissues, and in serious cases, death.

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OTC Benzocaine Teething Products Not Safe for Young Children

“If companies do not comply, we will take action to remove these products from the market,” the agency said.

The FDA urged these manufacturers to make the following label changes for their products for use in children age 2 and older:

  • add a warning about methemoglobinemia,
  • add contraindications directing parents and caregivers not to use the product for teething in infants and children younger than age 2, and
  • revise directions to include a warning against use in infants and children younger than age 2.

“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,” said FDA Commissioner Scott Gottlieb, M.D., in a news release.(www.fda.gov)

Health Care Professional Guidance

When recommending or prescribing local anesthetic products, the FDA advises health care professionals to warn patients about the potential risk of methemoglobinemia, and its signs and symptoms.

The agency said patients at greater risk for complications related to methemoglobinemia include those with breathing problems such as asthma, bronchitis or emphysema; heart disease; or those who are elderly.

Additionally, health care professionals using local anesthetics during medical procedures should take steps to minimize the risk for methemoglobinemia, the FDA said.

“These include monitoring patients for signs and symptoms suggestive of methemoglobinemia; using co-oximetry when possible; and having resuscitation equipment and medications readily available, including methylene blue,” the agency’s drug safety warning said.

Benzocaine is a local anesthetic contained in some OTC products for the temporary relief of pain due to minor irritation, soreness or injury of the mouth and throat.

The FDA said benzocaine products are marketed as gels, sprays, ointments, solutions and lozenges under brand names such as Anbesol, Orabase, Orajel, Baby Orajel, Hurricaine and Topex, as well as store brands and generics.

Prescription local anesthetics include articaine, bupivacaine, chloroprocaine, lidocaine, mepivacaine, prilocaine, ropivacaine and tetracaine.

The FDA recommends that parents and caregivers follow the American Academy of Pediatrics’ recommendations(www.healthychildren.org) to assuage teething pain. These recommendations include

  • using a chilled teething ring that is kept in the refrigerator (not frozen), and
  • gently rubbing or massaging the child’s gums with a finger to relieve symptoms.

History of FDA Warnings for Teething Medications

In January 2017, the FDA cautioned parents and caregivers against giving children specific homeopathic teething tablets(www.fda.gov) because the drugs contained inconsistent amounts of belladonna, a toxic substance. These products included Standard Homeopathic Co.’s Hyland’s brand homeopathic teething products.

The FDA said it’s closely monitored the risk of OTC and prescription local anesthetics, and issued related warnings in 2014, 2011 and 2006.

“We estimate that more than 400 cases of benzocaine-associated methemoglobinemia have been reported to the FDA or published in the medical literature since 1971,” the agency’s drug safety warning said. “There are likely additional cases about which we are unaware.”

As part of its monitoring of this safety risk, the FDA said it recently evaluated 119 cases of benzocaine-associated methemoglobinemia that were reported to the agency and identified in medical literature between February 2009 and October 2017.

“We have continued to receive cases even after our 2014 communication,” the agency said. “Most of the 119 cases were serious and required treatment.”

Furthermore, the FDA said 22 of these cases occurred in patients younger than age 18, and 11 were in children younger than age 2. Four of the 119 patients died, including one infant.

“We also conducted a study comparing the relative ability of the two local anesthetics benzocaine and lidocaine to make methemoglobin,” the FDA’s drug safety warning said. “The study showed that benzocaine generated much more methemoglobin than lidocaine in a red blood cell model.”

The FDA concluded its drug safety communication by urging health care professionals and consumers to report adverse reactions involving benzocaine or other medicines to the FDA’s MedWatch program.(www.fda.gov)

The agency said it will continue to monitor the safety of benzocaine products and take additional actions as appropriate.

Related AAFP News Coverage
FDA Proposes New Approach to Regulating Homeopathic Drugs
(1/8/2018)

Don’t Use Lidocaine to Treat Teething Pain, FDA Cautions
(7/9/2014)

Risk Posed by Popular Teething Meds Prompts FDA Warning to Parents, Physicians
Family Doc Offers Alternatives to Benzocaine Products
(4/12/2011)

WARNING – Orajel Type Products Not Safe for Baby

If you have a teething child at home, the Food and Drug Administration says DO NOT use over the counter numbing products like Baby Orajel.

Products containing benzocaine should not be used to treat infants and children younger than 2 years…these products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething.

They also warn adults should pay close attention to the label warnings, as it could be dangerous for them, too. What’s the problem? Benzocaine is a local anesthetic, and it can reduce the oxygen in your blood to dangerous levels and even cause death.

Most companies producing the projects are expected to change their formulas, but until they do, look for the ingredient benzocaine and steer clear of it. According to CBS News, the company that makes Orajel (Church and Dwight Co. Inc.) has four teething projects and will stop producing them. Adult Orajel is not being discontinued.

Read the entire FDA warning HERE.

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