If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market.
Benzocaine is associated with a risky health condition called methemoglobinemia, that results in decreased oxygen in the blood - and that could lead to death.
Benzocaine-containing products sold over the counter to relieve babies' teething pain are too risky and should no longer be sold, the FDA said Wednesday. Manufacturers of approved, prescription local anesthetics will have 30 days to reply to the FDA's letter regarding these new Safety Labeling Changes. These call for use of rubber teething rings or a simple finger-massage of the child's gums.
They also warn against using homeopathic alternatives.
With regard to OTC products, clinicians should instruct patients looking to use benzocaine-containing products to apply only a small amount and not to use the product more than 4 times per day; signs and symptoms of methemoglobinemia may appear within minutes to 1-2 hours after use. "In addition, we are adding warning statements to more clearly identify the risks and symptoms presented by methemoglobinemia, a rare but serious condition associated with the use of benzocaine". They include pale, gray- or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; headache; lightheadedness; and a rapid heart rate. Medications, foods, and water containing nitrites and nitrates may also induce methemoglobin formation that may be additive to that formed with benzocaine products. All drug products, including local anesthetics, should be stored out of reach of children.
"I have, for a while, cautioned against topical gels because of the danger, and babies are in the population at the highest risk for harm, and if you look at the risk versus benefit, it's not even all that helpful", said Dr. Lisa Thebner, a New York-based pediatrician.
The FDA has expressed doubts that these teething products are actually effective.