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Benzocaine Oral Products

In response to safety warnings about the danger of a life-threatening side effect, methemoglobinemia, 1 people may be searching the internet for information about benzocaine oral products used for mouth pain and teething.

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Developed methemoglobinemia after taking Benzocaine?

What Is Benzocaine?

There is a simple answer to the question of “What is benzocaine?” Benzocaine is an ingredient in topical anesthetics that can be bought over the counter. Products containing it are marketed to relieve minor pain and discomfort affecting your skin and mouth. 2

Anbesol, HurriCaine, Orabase for Mouth Pain

Most benzocaine products are marketed to relieve gum and mouth pain, canker sores, sore throats, and other mouth irritation. Examples of products containing benzocaine marketed to relieve mouth and gum pain include: 3

  • Anbesol.
  • Cepacol.
  • HurriCaine.
  • Orabase.
  • Orajel.
  • Baby Orajel.
  • Topex.

Benzocaine is also an ingredient in products marketed to alleviate discomfort from insect bites, sunburn, minor scrapes, and poison ivy, oak, and sumac: 4

  • Anacaine
  • Chiggerex
  • Mandelay
  • Medicone
  • Outgro
  • Solarcaine

The basic answer to the question “What is benzocaine?” is that benzocaine is an ingredient added to local anesthetics that are often applied topically on a specific area of irritation. Benzocaine can numb that area temporarily. 5

What Is Benzocaine Used For?

People may wonder, “What is benzocaine used for?” It is often used, incorrectly, in an attempt to ease teething pain in infants. Adults and children also may use benzocaine-containing products when suffering from oral or mouth pain.

The U.S. Food and Drug Administration (FDA) has recently specifically cautioned consumers about the dangers of over-the-counter benzocaine products intended to relieve mouth and gum irritation, canker sores, sore throats, and other mouth discomfort. The FDA has cautioned parents and caregivers that benzocaine-containing products should not be used on teething infants. Not only are these products ineffective for teething pain, they can also pose serious, potentially fatal risks to babies. 6 7

Mouth, Gums, and Throat Soreness and Irritation

Some benzocaine products are marketed as oral numbing agents. Oral numbing agents are applied to surfaces within the mouth. 8

In recent years, adults and children alike have used oral numbing agents in an attempt to alleviate mouth and gum pain. In fact, some benzocaine-containing products have been marketed specifically for use in infants and young children for teething pain. 9

Examples of products containing benzocaine that have been marketed specifically for teething infants and young children include:

  • Orajel Medicated Teething Gel.
  • Orajel Medicated Nighttime Teething Gel.
  • Orajel Medicated Daytime & Nighttime Teething Twin Pack.
  • Orajel Medicated Teething Swabs.

Church & Dwight Co., Inc., the manufacturer of Orajel, has voluntarily discontinued distribution and sale of these products in light of the FDA’s recent Safety Communication. 10

Local Medical Anesthesia

In addition, some benzocaine-containing products have been used by doctors for certain types of medical procedures. For example, endoscopies, laryngoscopies, and intubation all involve inserting a tube through the mouth and down the throat so that physicians can examine parts of the upper digestive tract, respiratory tract, or maintain an open airway.

Patients often experience discomfort during these procedures. Physicians may attempt to alleviate this discomfort by applying benzocaine-containing solutions. This practice has resulted in many cases of severe complications resulting from the use of the benzocaine-containing product. 11

Skin Rashes, Bites, Burns, and Other Irritation

Some over-the-counter benzocaine products are marketed for use on the skin. People with sunburns, insect bites, or rashes from poisonous plants have purchased benzocaine products in an attempt to relieve these types of pain, itching, and other discomfort. 12

Benzocaine products are also marketed for minimizing the discomfort of hemorrhoids, itching around the anus or genitals, and other irritation. Temporarily, topical over-the-counter benzocaine products can numb specific areas of the body. 13

Benzocaine Topical Products

Benzocaine products belong to a group of drugs called topical local anesthetics. Benzocaine topical products and other topical anesthetics temporarily deaden the nerve endings in the skin. 14

Many benzocaine topical products are often available without a prescription, known as over-the-counter. They are marketed in various forms, including: 15

  • Sprays.
  • Liquids.
  • Solutions.
  • Gels or jellies.
  • Ointments.
  • Creams.
  • Waxes.

Benzocaine-containing topical products are marketed to relieve the pain of sunburns and other minor burns, as well as minor scratches and cuts. These products are also marketed to alleviate the itching and pain caused by insect bites or stings, poison ivy, poison sumac, and poison oak. 16

Benzocaine Sprays or Aerosols

Benzocaine sprays are marketed to be used for numbing parts of the mouth or throat, and have at times been used before some medical procedures. For example, if patients need to have a tube inserted down their throat, such as during an endoscopy or intubation, a doctor may numb the mouth and throat first. 17

Dentists have also used benzocaine sprays in an effort to reduce pain when fitting a patient for dentures. Afterwards, some patients may also turn to a benzocaine spray product while their gums are getting used to the new dentures in an attempt to relieve pain or discomfort. 18

Benzocaine Gels or Jellies

Benzocaine gels and liquids, among other benzocaine formulations such as ointments, solutions, and lozenges, have made the news in 2018. In May, the FDA issued a safety warning about benzocaine gels and other products. 19 20

Although the Safety Communication applied to all consumers, the FDA noted it was requesting that over-the-counter benzocaine product manufacturers add new warnings regarding methemoglobinemia generally. The FDA especially cautioned consumers about over-the-counter products containing benzocaine marketed for teething.

The benzocaine gels and other benzocaine products “pose a serious risk to infants and children” because they can cause methemoglobinemia. This is a condition, the FDA explains, “in which the amount of oxygen carried through the blood is greatly reduced” while also having “no demonstrated benefit” for teething. 21

Some benzocaine products have been marketed to consumers as pain relievers for teething pain and discomfort in infants and children. The FDA has now asked manufacturers to voluntarily stop marketing over-the-counter oral products containing benzocaine as teething discomfort aids for infants and children. 22

The agency has said it will take action to remove products containing benzocaine marketed as teething aids for children and infants if manufacturers do not act first. In addition, the FDA has requested manufacturers add new warnings regarding methemoglobinemia to all of their oral products containing benzocaine, including those for adults. Examples of these products include: 23

  • Anbesol.
  • Cepacol.
  • Cetacaine.
  • Exactacain.
  • HurriCaine.
  • Orabase.
  • Orajel.
  • Baby Orajel.
  • Topex.

What Are the Side Effects of Benzocaine?

According to the FDA, products containing benzocaine can lead to serious side effects. One of these dangerous side effects is a medical condition called methemoglobinemia. 24

Methemoglobinemia is a medical condition involving the blood. When someone uses a product containing benzocaine, even for the very first time, this serious side effect can occur. 25

Usually, your blood delivers essentials, such as oxygen and nutrients throughout your body, to all of your cells, tissues, and organs. Humans need oxygen to survive: every part of your body needs oxygen to function properly. 26

However, if you develop methemoglobinemia, sufficient oxygen cannot reach your cells, tissues, and organs. The chemical makeup of your blood changes, with more of the blood being composed of methemoglobin than hemoglobin, preventing enough oxygenated blood from reaching all of the body’s tissues.

If cells and other organs are deprived of oxygen, people may turn blue (known as becoming cyanotic), and in this condition people need to seek medical attention immediately. 27

Before using or purchasing products containing benzocaine, you should ask, “What are the side effects of benzocaine?” Consumers need to know the risks. 28

Methemoglobinemia Symptoms

The symptoms listed may be possible signs of methemoglobinemia. Parents, in particular, are advised to consider “What are the side effects of benzocaine?” if you see your child exhibiting: 29

  • Pale, gray-, or blue-tinted skin, lips, or nail beds.
  • Shortness of breath or difficulty breathing.
  • Rapid heart rate (tachycardia).
  • Lightheadedness.
  • Fatigue.
  • Headache.

Everyone is advised to be aware of these methemoglobinemia symptoms. In severe cases, methemoglobinemia can be lethal. Adults and children have died from methemoglobinemia after being exposed to products containing benzocaine. 30

Baby Orajel

Baby Orajel is just one of the benzocaine products the FDA has asked manufacturers to voluntarily stop marketing for children. In 2018, the FDA issued new warnings regarding oral products containing benzocaine, especially those marketed as teething pain aids for children and infants. 31

In 2012, the agency specifically cautioned consumers about the dangers of benzocaine products marketed for teething. The FDA concluded that Baby Orajel and other over-the-counter products containing benzocaine marketed for teething can be dangerous to children, especially those younger than 2 years of age. 32

According to the FDA, using “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. … And children under 2 years old appear to be at particular risk.” 33

Orajel for Babies

Parents may be wondering what they can do to ease their infant’s teething pain if Orajel for babies and other benzocaine-containing products marketed for teething pain is not safe. The FDA, along with the American Academy of Pediatrics, has suggested parents try these safer alternatives to ease teething pain. 34

  • Give your child a chilled teething ring to gnaw on.
  • Massage your child’s gums gently using your finger.

The Mayo Clinic has also offered these remedies to relieve your child’s teething discomfort instead of using Orajel for babies or other benzocaine-containing products marketed for teething pain: 35

  • Give your baby a cold washcloth or spoon to suck on. Parents should, however, supervise their children when they are sucking or chewing on anything they could choke on accidentally.
  • Give your infant a hard food such as a cucumber or carrot to gnaw on if they are able to eat solid foods. Again, make sure to supervise your child.
  • Dry your child’s drool. Drooling is part of the teething process, but keeping your child’s skin dry can prevent skin irritation.
  • Consider applying a baby-safe moisturizer to your baby’s skin, again to prevent irritation from drooling induced by teething.

According to the FDA, products containing benzocaine do not help ease teething discomfort. Putting these benzocaine-containing products on your baby’s gums is exposing your child to the potential for the serious, potentially life-threatening side effect methemoglobinemia, while providing no benefit in the form of teething relief. 36

Cetacaine for Medical Procedures

Cetacaine, which is 14% benzocaine, is a topical anesthetic marketed for use as a numbing agent on mucus membranes. 37

Cetacaine has been used for “surgical or endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus.” 38

There are many case reports of Cetacaine causing methemoglobinemia when administered during or after medical procedures. 39 40

Benzocaine Warnings Apply to Everyone

The FDA has specifically instructed manufacturers to voluntarily stop marketing and selling benzocaine products for infants and children who are teething. It is also urging manufacturers to change labeling to warn of the risk of methemoglobinemia for everyone. 41

The FDA has advised consumers to check the over-the-counter Drug Facts Label when purchasing oral consumer products. If benzocaine is listed as an active ingredient in the product, consumers should be aware of possible benzocaine side effects. One possible and serious medical complication that can result from using oral benzocaine-containing products is methemoglobinemia. This a serious condition that affects the blood’s ability to efficiently transport oxygen to the body. 42

According to the FDA, “Signs and symptoms may occur after using benzocaine for the first time, or after prior uses and may appear within minutes to 1 to 2 hours after using benzocaine.” Possible symptoms of methemoglobinemia include: 43

  • Pale, gray- or blue-colored skin, lips, and nail beds.
  • Shortness of breath.
  • Rapid heart rate.
  • Headache.
  • Fatigue.
  • Lightheadedness.

If you notice any of these symptoms after using a product containing benzocaine, you should seek immediate medical attention. Methemoglobinemia is a serious medical condition and can lead to death. 44

Benzocaine and Methemoglobinemia

The FDA has identified hundreds of cases where people developed methemoglobinemia after using an over-the-counter product containing benzocaine. Some individuals died after using a product containing benzocaine, due to methemoglobinemia. 45

Life-threatening methemoglobinemia occurs when the level of methemoglobin in a person’s blood is greater than 55%. When the level of methemoglobin in a person’s blood is between 30% and 55%, or when a person is administered methylene blue regardless of the level of methemoglobin in the blood, the FDA categorizes methemoglobinemia as serious. 46

In children who are healthy, the level of methemoglobin in the blood is roughly 4% to 6%. In adults who are healthy, the level of methemoglobin in the blood is approximately 2% to 4%. 47

In human blood, the hemoglobin in red blood cells delivers oxygen and other nutrients throughout the body. When someone develops methemoglobinemia, hemoglobin begins to transform into methemoglobin. 48 49

Less hemoglobin and more methemoglobin means that blood is not able to deliver sufficient oxygen throughout the body. This medical condition can be life-threatening, even lethal. 50 51

  1. U.S. Food & Drug Administration. (2018, May 23). FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm
  2. Ibid.
  3. Ibid.
  4. Mayo Clinic. (2017, March 1). Benzocaine (Topical Application Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/benzocaine-topical-application-route/description/drg-20072913
  5. Ibid.
  6. U.S. Food & Drug Administration. (2018, May 23). FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm
  7. U.S. Food & Drug Administration. (2018, May 23). Do Teething Babies Need Medicine on Their Gums? No. Retrieved from https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm385817.htm
  8. U.S. Food & Drug Administration. (2018, May 31). Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm608265.htm
  9. Christensen, J. (2018, May 23). FDA warns that benzocaine teething products aren't safe for children. Retrieved from https://www.cnn.com/2018/05/23/health/fda-benzocaine-teething-warning/index.html
  10. Orajel. (n.d.) Orajel™ Medicated Nighttime Teething Gel (discontinued). Retrieved from http://www.orajel.com/en/Products/child-oral-care/Orajel-Medicated-Nighttime-Teething-Gel
  11. Collins, J.F. (1990, January). Methemoglobinemia as a complication of 20% benzocaine spray for endoscopy. Retrieved from https://www.gastrojournal.org/article/0016-5085%2890%2991312-T/pdf?referrer=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2F
  12. Mayo Clinic. (2017, March 1). Benzocaine (Topical Application Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/benzocaine-topical-application-route/description/drg-20072913
  13. WebMD. (n.d.). Boil Ease Ointment. Retrieved from https://www.webmd.com/drugs/2/drug-164078/boil-ease-benzocaine-topical/details
  14. Mayo Clinic. (2017, March 1). Benzocaine (Topical Application Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/benzocaine-topical-application-route/side-effects/drg-20072913
  15. Ibid.
  16. Ibid.
  17. WebMD. (n.d.). Benzocaine Aerosol, Spray. Retrieved from https://www.webmd.com/drugs/2/drug-18404-6252/benzocaine-mucous-membrane/benzocaine-spray-mucous-membrane/details
  18. Ibid.
  19. U.S. Food & Drug Administration. (2018, May 23). FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm
  20. U.S. Food and Drug Administration. (2018, May 23). Drug Safety Communications. Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. Retrieved from https://www.fda.gov/downloads/Drugs/DrugSafety/UCM608424.pdf
  21. Ibid.
  22. Ibid.
  23. Ibid.
  24. Ibid.
  25. Ibid.
  26. PubMed Health. (2016, August 1). How does the blood circulatory system work? Retrieved from https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0072434/
  27. U.S. Food & Drug Administration. (2018, May 23). FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm
  28. Ibid.
  29. Ibid.
  30. U.S. Food and Drug Administration. (2018, May 23). Drug Safety Communications. Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. Retrieved from https://www.fda.gov/downloads/Drugs/DrugSafety/UCM608424.pdf and U.S. Food & Drug Administration. (2012, January). Risk of methemoglobinemia in the medicine cabinet. Patients need to know about benzocaine. Retrieved from https://www.fda.gov/downloads/ForHealthProfessionals/LearningActivities/UCM288131.pdf
  31. U.S. Food & Drug Administration. (2018, May 23). FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm
  32. U.S. Food & Drug Administration. (2018, May 09). Benzocaine and Babies: Not a Good Mix. Retrieved from https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm306062.htm
  33. Ibid.
  34. Ibid.
  35. Mayo Clinic Staff. (2018, January 27). Infant and toddler health. Retrieved from https://www.mayoclinic.org/healthy-lifestyle/infant-and-toddler-health/in-depth/teething/art-20046378
  36. U.S. Food & Drug Administration. (2018, May 23). FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm
  37. RxList. (2018, January 19). Cetacaine. Retrieved from https://www.rxlist.com/cetacaine-drug.htm
  38. Ibid.
  39. Seibert, R.W. & Seibert, J.J. (1984, June). Infantile Methemoglobinemia Induced by a Topical Anesthetic, Cetacaine. Retrieved from https://onlinelibrary.wiley.com/doi/epdf/10.1288/00005537-198406000-00016
  40. Anderson, S.T., et al. (1988, November).Benzocaine-Induced Methemoglobinemia in an Adult: Accuracy of Pulse Oximetry with Methemoglobinemia. Retrieved from https://journals.lww.com/anesthesia-analgesia/Citation/1988/11000/Benzocaine_Induced_Methemoglobinemia_in_an_Adult_.15.aspx
  41. U.S. Food & Drug Administration. (2018, May 23). FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm
  42. Ibid.
  43. Ibid.
  44. Ibid.
  45. U.S. Food & Drug Administration. (2012, January). Risk of methemoglobinemia in the medicine cabinet. Patients need to know about benzocaine. Retrieved from https://www.fda.gov/downloads/ForHealthProfessionals/LearningActivities/UCM288131.pdf
  46. Ibid.
  47. Rechetzki, K.F., et al. (2012). Reference values for methemoglobin concentrations in children. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3459601/
  48. American Society of Hematology. (n.d.). Blood Basics. Retrieved from http://www.hematology.org/Patients/Basics/
  49. Rechetzki, K.F., et al. (2012). Reference values for methemoglobin concentrations in children. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3459601/
  50. Ibid.
  51. U.S. Food & Drug Administration. (2018, May 23). FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm