FDA Issues Strong Warning To Parents: Don’t Give Homeopathic Teething Products To Babies

The Food and Drug Administration (FDA) has a warning for parents who administer homeopathic remedies to teething babies: “All natural” doesn’t always mean all right for your child.

In other words, parents should not give homeopathic teething products to their children. These remedies could, in fact, be dangerous.

Homeopathic Doesn’t Mean FDA Approved

Homeopathic products may have “all natural” ingredients, but that doesn’t mean the FDA approves them.

These products are regulated by the FDA, but they do not evaluate them for safety or effectiveness.

This means the FDA evaluates the products to make sure they comply with government policies, however, the products don’t undergo scientific testing to make sure they are safe or actually work.

The FDA does take action when consumers complain, though.

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The FDA First Warned Consumers About Homeopathic Teething Products Last Fall

Back in September 2016, the FDA released a warning against using homeopathic teething products on infants.

FDA photo
Getty Images | Manny Ceneta

In their press statement, the FDA listed a variety of potential side effects from using these products, including:

  • Seizures
  • Difficulty breathing
  • Lethargy
  • Excessive sleepiness
  • Muscle weakness
  • Skin flushing
  • Constipation
  • Difficulty urinating
  • Agitation

The FDA began to look at these remedies in 2010 after parents reported symptoms in their children. In September 2016, the agency said it would continue to investigate.

Now, the results are in, and it doesn’t look good.

Inconsistent Levels Of A Toxin Are Present In The Tablets

In January 2017, the FDA released study findings showing “inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets.”

Atropa Belladonna is an herb that also has another, more common name: deadly nightshade. In small doses, it can be a pain reliever. However, too much of it, especially in young people, can be poisonous.

“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

According to the report, these levels sometimes “far exceeded” the amount claimed on the product label.

As a result, the FDA warned consumers that homeopathic teething tablets containing belladonna “pose an unnecessary risk to infants and children” and urged parents not to use them.

More Than 370 Children May Have Been Affected

In an information review, STAT.com discovered that the FDA looked at “adverse events” in more than 370 children using homeopathic teething products over a 10-year period (2006-2016).

Within that review, eight children reportedly died after using Hyland’s Teething Tablets or Teething Gel. However, the FDA has not confirmed whether the product was the sole cause of death.

Other symptoms, including seizures, breathing problems and limb twitching, were discovered in the information review.

Homeopathic Remedies Remain On Shelves

Hyland’s said it will discontinue its products, but will not issue a recall on items currently on store shelves.

In the meantime, FDA doctors warn parents against using homeopathic products even though they can be found in stores.

“Teething can be managed without prescription or over-the-counter remedies,” said Woodcock. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”