How Is This OTC Dental Gel Risky for Your Children?

FDA warns parents about teething products

In a recent news release, the U.S. Food and Drug Administration (FDA) has urged all companies producing teething products that contain benzocaine to stop manufacturing them. Benzocaine is a general-purpose pain reliever that is also used as a teething gel to help relieve sore gums in babies. 


The Press Release

The FDA posted this press release on May 23, 2018. In the press release, it is claimed that teething products with benzocaine that are used with children and infants under the age of two present a potentially serious risk to them. An additional problem that occurs with these products is that there is no perceived benefit to using them.


The Risk

The primary problem with benzocaine is that the FDA says it continues to receive reports that infants are being seriously injured and or dying because of a medical condition called methemoglobinemia. This condition is where the amount of oxygen that a red blood cell can carry is seriously reduced. Benzocaine is inducing this condition in some babies. 


The Threat

The FDA warns that if companies do not comply with their request that they will take action to remove all such products off of the market. This action will be taken because of the seriousness of the condition. 

The FDA is also urging companies to place a warning label about the safety of benzocaine on any product containing the ingredient. The label must contain information about the medical condition called methemoglobinemia, and also that it should not be used on anyone less than two years old. 


About Methemoglobinemia

The condition is said to be rare, but parents should take precautions not to use the product on children under two. The Pharmacy Times lists the following products that should not be marketed anymore because they contain benzocaine for teething infants: Anbesol, Orabase, baby Orajel, Orajel, Topex, and Hurricaine. 

The FDA claims that there have so far been about 400 cases of methemoglobinemia since 1971. Of this number, about 11 of them were infants under two years old.


Parents Advised to Use Caution

The FDA’s warning is also supposed to encourage parents to be careful about using benzocaine in other products for oral health. They advise not using any products for people above two years if there is not a warning label on the product. 

The government agency also wants medical professionals to warn their patients of the dangers of local anesthetics, and that they should watch for signs and methemoglobinemia symptoms. They suggest that medical offices should also have resuscitation equipment on hand. 


Warnings Against Other Teething Products

The Food and Drug Administration has also provided warnings against other teething products. These are homeopathic teething tablets. The tablets were discovered by a lab to have higher amounts (some products had much higher amounts) of belladonna in the product than what the label claimed. Belladonna is a toxic substance. 

The agency advises that these products should be discarded. It cannot be predicted how the child’s body will respond to an uncertain amount of belladonna.  

If a child should have certain types of reactions, they should seek medical help immediately. The potentially life-threatening symptoms include skin flushing, seizures, difficulty in breathing, constipated, difficulty urinating or being agitated. 


Symptoms of Methemoglobinemia

Methemoglobin is a type of hemoglobin that does not release oxygen to the cells as it passes through the bloodstream. Healthy people normally have less than one percent of this type of hemoglobin in their blood. Enzymes will normally transform this type into regular hemoglobin. 

The presence of certain chemicals, such as benzocaine or nitrates found in some well water, boost the methemoglobin level. As the level of this type of hemoglobin increases, there is a greater risk of serious health problems, and it can be fatal. 

Once the level of methemoglobin (also called MetHb) reaches between three to ten percent, the skin will begin to appear to have a bluish-gray tint. As it gets between 15 to 30 percent, the blood will take on a chocolate brown color. When levels get between 30 and 50 percent, the following symptoms can be expected:


  • Fatigue
  • A rapid heartbeat
  • Dizziness
  • A headache
  • Shortness of breath
  • Confusion
  • Weakness
  • Becomes unconscious.

When the levels of MetHb get to 50 to 70 percent, there will likely be an abnormal heartbeat, seizures, and kidney problems. As levels get above 70, it is likely to be fatal. 


Diagnosis and Treatment

Blood tests that measure the amount of functional hemoglobin are all that is needed to determine methemoglobinemia. A test called pulse oximetry will test the amount of oxygen in the blood. 

There are many safe ways to help soothe a baby that is teething. The American Dental Association suggests that you use teethers that are made of solid rubber, a small spoon, or you can also rub their gums with a clean finger. 


When your children, or you, need help with teeth pain, or from teething, you can visit the ToothHQ dental offices in Carrollton, Cedar Hill, Grapevine, and Dallas TX areas for a free consultation. You can call our office today for an appointment or for information at (214) 731-0123.