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Label courtesy of www.dailymed.nlm.nih.gov.

This article doesn’t discuss the merits of homeopathic remedies (some of which the author finds helpful) versus allopathic treatments (drugs, etc., some of which the author also finds helpful). Instead, the point is to inform the public about a potential problem with some homeopathic remedies. Specifically, the FDA is concerned about excessive levels of belladonna in homeopathic teething products.

Atropa belladonna has been around for a very long time. While it is widely understood to be toxic, in the proper amounts it does have uses in healthcare and even some prescription drugs. However, in improper amounts… well, the historical rumors have it that two Roman Emperors met their ends due to belladonna poisoning. There is an old saying in certain circles: “What can kill, can cure” and belladonna is no exception. Homeopathic teething products containing belladonna have been around for years and have provided great relief to many a teething infant (and, no doubt, to their exhausted parents).

Why the fuss now?

A laboratory analysis conducted by the FDA of some homeopathic teething products found that the amount of belladonna in these products is not only inconsistent over multiple “batches,” but in some cases, far exceeded the amount listed on the products’ labels. In response to these findings, the FDA is warning the public that belladonna-containing homeopathic teething products should not be used due to the risk to infants’ and children’s health.

The problem is that belladonna, in the wrong amounts, can cause “seizures, excessive sleepiness, muscle weakness and skin flushing.” Furthermore, the FDA cites over 400 reports of side effects and ten fatalities, linked to these products since 2010.

According to Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, “The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk. We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”

The Agency is erring on the side of caution. Since homeopathic teething products aren’t tested and approved by the Agency for safety and efficacy, it is focused on preventing any further injuries. The FDA claims it is unaware of any proven health benefits of homeopathic teething products, but my (hopefully) healthy skepticism regarding that Agency tells me that it doesn’t know of benefits because there’s no money coming its way.

In other words, there are (from anecdotal reports received by the author) benefits to these homeopathic teething products, but the FDA speaks only two languages: science and cash. Take a guess at which one is its primary language. Hint: It’s not science.

However, that does not mean that the findings of potentially dangerous levels of belladonna in these homeopathic teething products should be ignored.

Standard Homeopathic Company, the LA-based producer of Hyland’s homeopathic teething products, received a request from the FDA to issue a product recall of the products. Hyland’s “declined” issuing a recall stating that it no longer produces the product in question. The company claims it discontinued the homeopathic teething products in October 2016 following the re-opening of a 2010 investigation into product safety in September.

A Hyland’s spokesperson, Mary Borneman said, “We don’t see any additional action to be necessary.”

A customer who also thinks the deserve better! Image courtesy of www.tensionNOT.com.
A customer who also thinks the deserve better! Image courtesy of www.tensionNOT.com.

How kind and compassionate of Ms. Borneman. Simply because the products were discontinued does not mean they aren’t currently in countless homes across the nation. For shame, Ms. Borneman! Hyland’s owes its customers better, I believe. So, I would request, dear readers that you check your medicine cabinets for these Hyland’s products, stop using them and dispose of them as the FDA advises. Just because Hyland’s “declined” informing and protecting you, doesn’t mean you and your children should remain at risk.

Raritan Pharmaceuticals, another producer of belladonna-containing homeopathic teething products, recalled three of theirs in November 2016. Two of these products were sold at CVS and that chain pulled the products from its shelves.

What to watch for if you’re using these products:

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

If your child exhibits any of these symptoms after taking a homeopathic teething product, you should seek immediate medical attention.

In addition, the Agency asks that healthcare providers and customers report any adverse events to the FDA’s MedWatch Adverse Event Reporting program. To do so online, click here. Alternatively, you can download this form and fax it to the FDA at 1-800-FDA-0178.

In the meantime, the Agency advises parents to seek alternative methods of helping their children through teething. According to the American Academy of Pediatrics, the following methods may be helpful:

  • Rub the child’s gums with a clean finger
  • Provide the child a solid teething ring
  • Provide the child a clean, wet washcloth (chilled in the freezer) to chew on
  • Give the child frozen bagels, berries or bananas

They also suggest a “weight-appropriate dose of acetaminophen,” but advise parents to consult their pediatricians to determine the proper dose.

While I’m not a fan of the FDA’s stance on alternative medicines, like homeopathic teething products, I am in favor of keeping the public safe. If avoiding a potentially dangerous product saves a life, I’m OK with siding with the FDA for once.

And, to avoid making some folks as cranky as their teething children, I won’t add the remedies my Mom – and many others of her generation – used to great success.

Sources:

FDA warns against use of homeopathic teething products
FDA confirms elevated levels of belladonna in certain homeopathic teething products
ATROPA BELLADONNA
Teething tablets may be linked to 10 children’s deaths, FDA says

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