Over-the-counter teething medicines for infants are both ineffective and dangerous – and sometimes even fatal. The most common active ingredient, benzocaine, a local anesthetic, can cause a blood disease, methemoglobinemia, which prevents red blood cells from carrying oxygen to the baby’s body. Also, rubbing medicine with benzocaine on the gums when a child is teething does not seem to help the pain any better than just rubbing the gums without medicine.
When I was a very young doctor, hysterical parents ran into my office with a 3-month-old baby who had turned blue. The child was breathing rapidly, but wasn’t in enough distress yet for there to be a lung or heart problem. I gave the child oxygen, then spoke with the parents. They mentioned that they had used baby teething medication.
While waiting for the ambulance, I learned that the mother, father, and grandmother had all rubbed the baby’s gums with a benzocaine preparation in a short period of time because the baby was crying and drooling — the classic symptoms of teething. We were lucky that I had oxygen in my office, the ambulance came quickly, and the hospital had methylene blue (the antidote for methemoglobinemia) readily available.
The lower a baby’s weight, the more likely this awful side effect is to happen. The U.S. Food and Drug Administration issued another warning last month that medicated teething gels should never be used in children under 2. I personally have written for many years to never use this medicine on anybody because it is potentially harmful and does not work.
Why doesn’t the FDA just ban it? Legally, it cannot.
Currently, over-the-counter drug products can go on the market without FDA pre-approval if they adhere to the agency’s monograph system for their active ingredients such as what form it will take (i.e. a liquid or tablet) and the information for the label. That means the only immediate action the FDA can take is to strongly advise parents and physicians against using these products and ask companies to voluntarily remove them from store shelves.
Elizabeth Jungman, director of public health programs at the Pew Charitable Trust, said: “The FDA needs to be able to act swiftly when safety issues arise with OTC products. Pending federal legislation will give the FDA the authority and resources to deal with potentially harmful products more quickly and decisively.” U.S. Sen. Bob Casey (D., Pa.) has been championing Senate bill 2315, she said, and there is a similar bill in the House of Representatives – HR 5333. “We just need the leadership of both chambers to bring them to the floor for a vote.”
This problem is not new. The emergency I described happened more than 35 years ago. Parents have always been overwhelmed by babies crying from teething and have used some truly awful, dangerous methods to stop the pain such as alcohol, paregoric (a strong opioid), and now benzocaine. The American Academy of Pediatrics recommends just rubbing the swollen gums with your finger and letting the child chew on hard rubber teething rings. We want to stop the pain and crying immediately, but sometimes you just need to wait it out.
I hope that Congress will give the FDA the authority to ban dangerous medications from OTC products. If you care, contact your federal representatives with your opinion now.