Every infant goes through what is referred to as “teething”, where they experience pain as their baby teeth begin to poke through their gums. Over the years, many parents have turned to teething gels that contain the numbing ingredient benzocaine to ease their baby’s discomfort. This has long been a source of concern for pediatricians, and now the Food and Drug Administration is taking action.
On May 23, the FDA issued a warning to consumers that teething gels and creams containing benzocaine can cause rare but serious side effects in children. Conditions such as methemoglobinemia, which reduces the oxygen level in the blood, have been associated with the use of benzocaine, particularly in children under the age of 2. This and other serious illnesses can even lead to death in some cases.
Since 2009, 119 cases of methemoglobinemia related to use of benzocaine have been reported. A total of approximately 400 cases overall have been reported to the FDA since they began recording data. This has led federal health officials to issue several warnings to consumers over the years. Now they are threatening to take legal action if the companies that manufacture these products don’t voluntarily remove them from shelves immediately.
One manufacturer of Orajel, a brand of teething products known to contain benzocaine, has voluntarily discontinued several of their products. Church and Dwight Co. Inc., based out of New Jersey, announced that they are discontinuing the sale of four products:
- Orajel Medicated Teething Gel
- Orajel Medicated Nighttime Teething Gel
- Orajel Medicated Daytime & Nighttime Teething Twin Pack
- Orajel Medicated Teething Swabs
They will continue to manufacture other Orajel products. In addition, they are updating the warning label on products that contain benzocaine to clearly state the risks and symptoms associated with methemoglobinemia. Products will also contain an advisory that benzocaine should not be used in children younger than 2 years of age.
The FDA is hoping that other companies will follow suit and remove their products from store shelves immediately. They recently issued letters to several companies that manufacture products containing benzocaine, advising them of such.
The American Academy of Pediatrics is pleased that the FDA is taking more definitive action on removing these products from store shelves. They adjusted their recommendations years ago, advising parents not to give infants teething gel that contains either lidocaine or benzocaine because of the risk of serious complications. They warned that if a child were to ingest too much of the anesthetic, it could lead to seizures, heart problems, brain injury, or death.
They also point out that there have been no known clinical trials to prove that these numbing agents actually work to relieve teething pain. They have, however, been proven to be unsafe. Any mild pain relief that may occur does not last long because the teething gel washes out of a child’s mouth within minutes.
Instead of using teething gels, the AAP recommends that parents and other caregivers allow children to chew on a chilled, not frozen, teething ring that has been cooled down in the refrigerator. A frozen teething ring may be too hard on an infant’s gums and actually cause more discomfort. In addition, gently massaging a teething baby’s gums with a clean finger can also provide some pain relief.
If your child has been injured, please contact the Law Offices of Sadaka today.