Family physicians and other health care professionals who provide care for infants may soon be fielding questions from parents about how best to soothe children who are teething. That's because the FDA issued a safety announcement(www.fda.gov) on April 7 that warns parents and caregivers to not give OTC gel or liquid benzocaine products, such as Anbesol and Orajel, to children younger than 2 years old unless directed to do so by a physician.
The agency's action comes in response to nearly two dozen reports of methemoglobinemia, a rare but potentially fatal condition in which the amount of oxygen carried through the bloodstream is greatly reduced, stemming from use of these medications.
As an alternative to the commonly used teething medications, the FDA referred parents to recommendations(www.healthychildren.org) from the American Academy of Pediatrics, or AAP, that suggest gently rubbing or massaging their teething child's gums or giving the child a firm rubber teething ring.
"If these methods do not provide relief from teething pain, consumers should contact a health care professional to identify other treatments," the FDA said.
So, what alternatives could family physicians suggest to concerned parents?
Valerie King, M.D., M.P.H., of Portland, Ore., a member of the AAFP Commission on Health of the Public and Science, said she suggests parents try to provide their children with comfort care rather than medications.
"I've always thought putting numbing medication in a small child's mouth was a bad idea," said King, who is an associate professor of family medicine at Oregon Health & Science University. "Kids swallow what we put in their mouths -- that's why we don't give fluoride toothpaste to infants. They can't spit it out."
Her suggestion to parents and caregivers is to give teething babies something that is cold but malleable, such as a wet washcloth that has been wrung out, twisted like a rope, and frozen.
However, said King, parents and others should be discouraged from giving children teething rings and other products that have been frozen solid. "They freeze hard like ice, and that's too hard for a baby's mouth," she said. "Don't give them anything harder than a rubber teething ring."
If those methods fail to soothe the child, King said she suggests that caregivers provide a weight-appropriate dose of acetaminophen(www.tylenolprofessional.com). However, she emphasized, parents and other caregivers should be informed about proper dosages and per-day dosing limits because of the risk of liver damage posed by the medication.
King also said she discourages parents from treating their children with certain homeopathic remedies, such as teething tablets that contain belladonna and amber teething necklaces. Belladonna is a poison, and necklaces of any kind pose multiple safety risks with small children, according to King.
As for benzocaine, the FDA said in its safety announcement that children younger than age 2 years should not be given the medication except on the advice of and with supervision by a physician. The agency also cautioned that the topical anesthetic should be used sparingly -- no more than four times a day -- and only when needed.
The FDA said that methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5 percent. The products, which are used to treat canker sores and other irritations of the mouth and gums in addition to teething, have been associated with methemoglobinemia in adults as well as children.
Of the 21 cases reported to the FDA, 10 were considered life-threatening.
Meanwhile, the FDA also has received more than 300 reports of methemoglobinemia associated with the use of benzocaine sprays to numb the mucous membranes of the mouth and throat, including 32 cases that were categorized as life-threatening. Three deaths have been reported. The agency issued a separate safety announcement(www.fda.gov) related to those products, which include Hurricaine, Cetacaine, Exactacain and Topex.
The risks associated with methemoglobinemia and benzocaine are not yet included on the labels of any benzocaine products, according to the FDA.
A list of OTC products(www.fda.gov) containing benzocaine is included in a question-and-answer document issued by the agency.