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June 7, 2012
Here’s an important health alert for parents, grandparents and other caregivers of children younger than 2 years old.
Do not use over-the-counter (OTC) products containing the drug benzocaine — such as Anbesol, Hurricaine, Orajel, Baby Orajel and Orabase — to treat teething pain or other oral pain in children younger than 2 years old because the products can cause a rare, life-threatening condition called methemoglobinemia.
On May 31, 2012, the Food and Drug...
June 7, 2012
Here’s an important health alert for parents, grandparents and other caregivers of children younger than 2 years old.
Do not use over-the-counter (OTC) products containing the drug benzocaine — such as Anbesol, Hurricaine, Orajel, Baby Orajel and Orabase — to treat teething pain or other oral pain in children younger than 2 years old because the products can cause a rare, life-threatening condition called methemoglobinemia.
On May 31, 2012, the Food and Drug Administration (FDA) issued a consumer safety announcement about the dangers of OTC benzocaine-containing products commonly used to treat teething pain and other types of oral pain in babies.
As the announcement notes, 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 bloodstream is greatly reduced.” In the most severe cases, methemoglobinemia can result in brain damage or death.
While this disorder can affect people at any age, children younger than 2 appear to be at a particularly high risk. Since the FDA first warned about potential dangers of benzocaine products in 2006, the agency has received 29 reports of benzocaine gel-related cases of methemoglobinemia. Nineteen of those cases occurred in children, and 15 of the 19 cases occurred in children under 2, according to the FDA.
Methemoglobinemia Symptoms and Lack of Label Warnings
Symptoms of methemoglobinemia include:
- pale or gray- or blue-colored skin, lips and nail beds
- shortness of breath
- fatigue
- confusion
- headache
- light-headedness
- rapid heart rate
Symptoms can begin with the first use of the drug or may show up hours later or after several uses.
Surprisingly, labels on OTC products containing benzocaine are not required to carry warnings about the risk of methemoglobinemia. A parent of an infant noted the following after being made aware of the FDA consumer safety announcement:
“I got the teething gel (called ‘Little Teethers’) in a Little Remedies baby medicine kit bought in 2011. The only warning on the label was that it is for children 4 months or older, and ‘If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your child’s doctor promptly.’ I’m sure glad [Public Citizen is] up to date on all the baby health news, or I probably never would have heard about benzocaine.”
While the FDA recommends that parents and caregivers not use benzocaine products for children younger than 2, except under the advice and supervision of a health care professional, Public Citizen’s Health Research Group recommends that these products not be used at all in such patients.” Alternative treatments for teething pain include:
- Giving the child a teething ring chilled in the refrigerator
- Gently rubbing or massaging the child’s gums with your finger
Read the full FDA consumer safety announcement.
What You Should Do
If you are caring for a child younger than 2 years old, do not use benzocaine-containing products to treat teething or other oral pain. Keep all such products out of the reach of children.
If your child, or anyone else, develops the symptoms listed above after using a benzocaine product, stop using the product and seek medical help immediately by calling 911.
Report any adverse effects related to benzocaine products to the FDA MedWatch program.
