Apr 30 2017

FDA Weighs in to TKO Orajel and Hyland’s Tablets

Parenting a newborn is tough stuff, specially with a teething child. I’ve previously written on what to expect with suggestions on how to deal with a teething baby. Now the latest twist is how the FDA recommended against some of the commonly used remedies.

Teething has been a source of challenge and confusion since the first little cavemen children started having teeth pop through their gums. Its even been associated – often wrongly – as the cause of everything from fever to death.

In fact, in 1842, teething was the registered cause of death of 4.8 percent of babies in London who died before their first birthday.

This, needless to say, was nonsense.

In some ways, not much has changed. There’s still confusing and conflicting information out there.

For instance, last fall, the Food and Drug Administration weighed in and issued a warning about homeopathic teething tablets, such as those made by CVS and Hyland’s.

The agency advised parents to stop using the products while it looks into cases where seizures were reported in babies and toddlers who were given the tablets.

What’s more, the agency claims it’s “not aware” of any proven benefits.

The FDA also warned against medicated teething gels such as Orajel — but more on that later.

To clear the confusion, here’s the scoop on teething and what the FDA guidelines mean:


  • Homeopathic teething tablets and gels don’t have FDA approval, and aren’t covered by strict regulations for medications. What does that mean for you? Essentially, there’s a higher chance of manufacturing issues going unnoticed, leading to a product that could potentially harm kids.
  • Teething tablets often contain a product called Belladonna. Though its been used for centuries, it can be toxic, and the FDA has confirmed that elevated, inconsistent levels of this product are present in certain homeopathic teething products.
  • Teething gels often contain Benzocain, a topical anesthetic that numbs the mouth. But, the FDA says it’s been linked to a rare — but sometimes fatal — condition where the amount of oxygen carried through the blood stream is severely reduced.Those under age 2 can be most at-risk.

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