July 28, 2014
Public Citizen to FDA: Over-the-Counter Teething Medications for Infants Should Be Removed From the Market Because of Life-Threatening Reaction
Benzocaine Products Too Dangerous for Teething; Warning Labels Needed for Similar Product Intended for Use in Older Children and Adults Too
WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should not allow over-the-counter (OTC) benzocaine products to be marketed for treating teething in infants and toddlers because they can prompt a rare but potentially deadly adverse reaction, Public Citizen said today in a petition to the agency. In addition, the agency should require a warning about this adverse reaction on all other OTC benzocaine products intended for use in older children and adults.
Many benzocaine products available without a prescription are intended to ease gum pain and discomfort in infants and toddlers who are teething. But benzocaine – a topical anesthetic or numbing medicine found in a variety of gel, liquid and spray products – has never been demonstrated to be effective in relieving teething pain in clinical trials, and safer remedies are available.
Further, there is overwhelming evidence that the medication causes methemoglobinemia, a life-threatening disorder, and infants under the age of 2 are particularly susceptible to developing this condition. The disorder, which prevents red blood cells from carrying oxygen, can go unrecognized and is fatal in severe cases if left untreated. Signs and symptoms of the reaction include pale, gray or blue skin (cyanosis); headache; rapid heart rate; and shortness of breath.
“Most parents probably assume that because benzocaine products are available over the counter for teething in infants, the products must be safe and couldn’t possibly cause a fatal reaction if used as directed on the product label. But that assumption is wrong,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “Moreover, because this dangerous reaction can occur hours after an infant is given a single recommended dose, and many parents likely use the product before bedtime, the condition may occur while the baby is sleeping and unmonitored by the parents. It’s conceivable that fatal cases of methemoglobinemia due to benzocaine use in infants have been mistakenly attributed to suffocation or sudden infant death syndrome.”
Over-the-counter benzocaine products have been available for several decades, despite the fact that the FDA has never approved these drugs or finalized regulations proposed in 1991 that would permit them to be legally marketed. The agency has allowed companies to continue marketing these products as long as they comply with certain conditions, such as those regarding dosing and labeling, stipulated in the proposed 1991 regulations. These proposed regulations permit OTC benzocaine products to be marketed for “the temporary relief of sore gums due to teething in infants and children 4 months of age and older.”
Between 2003 and 2014, the FDA issued several safety announcements related to the risk of methemoglobinemia with OTC benzocaine products. In a May 2012 announcement, the FDA noted that gel and liquid products containing benzocaine had been associated with 29 cases of methemoglobinemia – 19 of those cases involved children, 15 of whom were under the age of 2. In its petition, Public Citizen summarized additional cases that had been reported in the medical literature.
In June, the FDA advised health care providers and consumers not to use OTC topical pain relievers such as benzocaine gels for teething pain because of the potential for harm and because there are much safer, non-drug alternatives. Notably, the agency stated, “Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes.”
In its petition, Public Citizen urges the FDA to take three actions:
• Revise the proposed regulations related to OTC benzocaine products to no longer permit the marketing of such products for teething pain;
• Require that all OTC benzocaine products in liquid or gel dosage forms include a label advising not to use the product to treat teething pain in infants; and
• Require warning labels on all OTC benzocaine products stating the risk of methemoglobinemia and listing the signs and symptoms of the life-threatening disorder.
“There is no reason infants and toddlers should be exposed to dangerous teething medications when there are safer, more effective non-drug remedies available,” said Carome. “The FDA needs to act swiftly to remove all OTC benzocaine products advertised for teething from the market and make sure parents and caretakers of infants and toddlers know not to use other benzocaine products to treat this mild condition that is a normal part of child development.”