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Baby Orajel Warning: Relieving Teething Pain Safely

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Teething's for chumpsThe FDA has released a warning to parents and caregivers about using over-the-counter benzocaine products to relieve pain associated with teething. Although there are many medications involved in this warning (see the list here), Baby Orajel is one of the most known and most commonly used remedies for teething pain in young children.

Benzocaine is a local anesthetic, a drug administered to induce partial or total loss of sensation, and is used to relieve pain in the mouth and irritation of gums. Benzocaine products come in a variety of forms including sprays, liquids and gels. Baby Orajel, available in gel form, is applied to the gums to help relieve the pain of teething.

The FDA has learned that benzocaine products can cause a serious life-threatening condition known as methemoglobinemia. Methemoglobinemia (MET-hemoglobin) is a condition where there is a build-up of methemoglobin in the blood, which reduces the ability of the blood to transport oxygen throughout the body.

Normally, methemoglobin levels contribute to less than 1% of all hemoglobin in healthy people. However, conditions from birth and outside factors such as medications (i.e. benzocaine) and nitrates accelerate the formation of methemoglobin in the blood. Hemoglobin carries oxygen rich blood to the body. Methemoglobin, on the other hand, cannot transport oxygen. Therefore when there is a build-up of non-oxygen carrying cells, the body does not receive the oxygen that it needs. When this occurs, the blood loses its bright red color and instead becomes chocolate-brown and skin color appears blue as a result of oxygen deprivation.

Signs and symptoms of methemoglobinemia include:

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Sophie The Giraffe Teether
  • pale, gray or blue colored skin, lips, and nail beds
  • shortness of breath
  • fatigue
  • confusion
  • headache
  • lightheadedness
  • rapid heart rate
  • loss of consciousness

These symptoms can appear rapidly after benzocaine use, occurring within minutes or up to two hours after use. If left untreated, seizures, coma and death could occur.

The FDA is warning parents and caregivers not to use benzocaine-containing medication on children younger than 2 years of age unless otherwise recommended by a physician. This warning has come after a search through the FDA’s database revealed 15 children (out of a sample of 21) acquired methemoglobinemia after application of a benzocaine gel to relieve teething pain. Of the cases reported, most of the children were given doses which exceeded the label recommendations.

The following are the recommendations from the FDA:

  • Labels of marketed benzocaine products currently do not contain warnings about the risk of methemoglobinemia, even though the use of benzocaine can cause this serious condition.
  • Benzocaine products should not be used on children less than 2 years of age, except under the advice and supervision of a healthcare professional.
  • Store benzocaine products out of reach of children.
  • If benzocaine products are used, watch for signs and symptoms of methemoglobinemia. If you or your child has any of these symptoms after taking benzocaine, seek medical attention immediately.
  • Signs and symptoms of methemoglobinemia may appear within minutes to one or two hours after using benzocaine. Symptoms may occur after using benzocaine for the first time, as well as after several uses.
  • The development of methemoglobinemia after treatment with benzocaine gels and liquids has been reported to occur following a single administration of the product.
  • Benzocaine gels and liquids should be used sparingly and only when needed, but not more than 4 times a day. If pain persists despite using the product as labeled, contact your healthcare professional for further evaluation and treatment recommendations.
  • Report side effects or medication errors from the use of benzocaine to the FDA MedWatch program.

Tips to Safely Relieve Teething Pain

Parents and caregivers can help to relieve the pain of teething in a variety of ways. For example:

  • Give your baby a chilled teething ring. Freezing teething rings or other teething items can cause frostbite and should be avoided. Avoid fluid-filled teethers; even those filled with water have been found to harbor harmful bacteria. Be sure teethers are large enough to prevent choking.
  • Massage your baby’s gums using a CLEAN finger.
  • If your baby is old enough and has been introduced to solids, chill veggies and/or fruit and place in a mesh feeder. Chilled celery in a mesh feeder works great.
  • Also, if your child is developmentally ready, teething biscuits can be a great teething treat. Learn how to make your own homemade teething biscuits here (this recipe is recommended for babies older than 8 months of age).
  • A chilled wash cloth is also a wonderful teething tool.
  • Provide your child with teething toys that do not require chilling. Sophie the Giraffe is a popular teething toy that is BPA-free, phthalate-free and PVC-free.
  • If none of these interventions work and your child seems to be in pain, acetaminophen (Tylenol) or ibuprofen (Motrin) can be given. Be sure to consult your baby’s healthcare provider to ensure adequate dosing.

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Sources:
AAP. Teething: 4-7 Months.

FDA Press Release (April 7, 2011). FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth.

FDA (May 31, 2012) Benzocaine and Babies: Not a Good Mix

MayoClinic.com. Teething: Tips for soothing sore gums

Wikipedia. Methemoglobinemia