FDA Warns Against the Use of Homeopathic Teething Remedies

Last week, the U.S. Food and Drug Administration (FDA) advised consumers to stop using homeopathic teething tablets and gels. The warning cited health risks including seizures, breathing difficulties, excessive sleepiness and other symptoms. This warning comes six years after the FDA advised consumers that one popular brand, Hyland’s, was manufacturing teething tablets that presented similar health problems.

The culprit is the herb belladonna, which means “beautiful lady” in Italian but is also regarded by many medical professionals as unsafe to use as a sedative. Belladonna is also used in ointments and salves for joint pain and even in hemorrhoid suppositories.

Homeopathic remedies for teething gained popularity in recent years after the FDA issued a warning in 2011 that urged adults not to treat teething children under the age of 2 with over-the-counter remedies such as Anbesol. That product, along with others such as Orajel, Orabase and Hurricane, contain the local anesthetic benzocaine. FDA researchers said the risk from using benzocaine is the rare but sometimes fatal condition methemoglobinemia, a health disorder that greatly reduces the amount of oxygen circulated through a child’s bloodstream.

Instead of a remedy containing belladonna or any other herbal or homeopathic remedy (and these non-conventional remedies share one thing in common: they are not based on science), the FDA suggests two simple alternatives: Rub or massage the child’s gums with a finger,  or offer a cool teething ring or a wet, clean and cool washcloth for the teething child to bite.

But the FDA warnings serve as an advisory and have no legal teeth. And homeopathic companies are responding in kind as they refuse to take any responsibility or accountability for the products they sell as they put profit ahead of product safety.

Take the example of Hyland’s dismissive response to the FDA warning. The company claims its products are made with “good manufacturing practices” without explaining further, and said the FDA inspects its products as if they were over-the-counter drug remedies. The company also perpetuates the myth that all homeopathic products are regulated exactly as drugs are by the FDA. Of course, on its website, Hyland’s also prints the disclaimer that its products' uses “have not been reviewed by the Food and Drug Administration.”

And in another rambling and defensive statement insisting its products are safe, Iris Bell, Hyland’s director of scientific affairs, minimized the risk of belladonna and said the company’s teething gel contains the ingredient in only small amounts. Once again, Bell said these products are manufactured using a “validated process” – without disclosing any details. And the legal hair-splitting over the insistence that homeopathic remedies are regulated by the FDA ignores the fact that the agency does not evaluate these potions for safety or effectiveness.

The bottom line is that the homeopathic product industry has long profited from its snake oil promise that the further dilution and “succession” of their ingredients increases their potency. So, should Hyland’s shake and dilute its products even more, or increase the amount of elixirs? Then there is the “like cures like” explanation, which posits the logic that an ingredient that produces negative results in healthy people will cure those same conditions in unhealthy people. The problem is that in the rush to soothe a child’s pain, many parents are buying something they believe is “natural” – and do not stop to ascertain whether they are giving potentially harmful substances to a perfectly healthy child.

At the very least, these statements are head-scratchers. At worst, they exhibit hypocrisy as these companies resent the very idea that they should be held to the same level of product safety as the makers of conventional products containing benzocaine. And their allies are the tightly-knit, eco-conscious “mommy blogger” community who often react to a criticism of one product as an attack on everyone. A typical response to concern over herbal remedies is an objection to “chomping on plastic” out of fears of BPA or other chemicals, though a walk through any store reveals that the makers of children’s products clearly denote when their products are free of such materials.

And now, stores are doing what they can to remove such products from their shelves. CVS, for example, recently announced it will voluntarily remove all homeopathic teething remedies from its shelves, including Hyland’s, Baby Orajel and its private-label products.

Image credit: Daniel Schwen/Wiki Commons