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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...
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.
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 years old 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 years of age.
Methemoglobinemia symptoms and 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 occur within minutes to hours after benzocaine use. They can begin after using the drug for the first time, as well as after several uses.
Surprisingly, labels on OTC products containing benzocaine are not currently required to carry warnings about the risk of methemoglobinemia.
While the FDA recommends that parents and caregivers not use benzocaine products for children younger than 2 years, 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
To read the full FDA consumer safety announcement, visit https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm306062.htm?source=govdelivery.
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.
| Learning About and Reporting Adverse Events In addition to reading Worst Pills, Best Pills News and checking WorstPills.org for warnings about new drugs, you should always review the newest product label for any new drug you are prescribed. FDA-approved product labels can be found online at the DailyMed website (http://dailymed.nlm.nih.gov/). If your drug requires a Medication Guide, it can be found in the product label or at https://www.fda.gov/drugs/drugsafety/ucm085729.htm, but it should be distributed to you when you fill or refill your prescription. Consumers may report serious adverse events or product quality problems to the FDA’s MedWatch Adverse Event Reporting program online or by regular mail, fax or phone.
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