Fact vs. Fiction in the Attack on Teething Tablets

The one thing this election has taught me is that “fact checking” can help people make a more informed decision.  Unfortunately, fact checking is not done when unsubstantiated claims about alternative therapies are made, which leads to confusion and unnecessary action.  Yes, I am still talking about Hyland’s teething tablets.  Last week, the FDA’s accusations caused Hyland to take the tablets off the market.  Hyland’s voluntary discontinuation of the product was likely done in hopes to quell continued attacks on homeopathy as a practice.  To be clear, neither Hyland OR the FDA recalled the products.  However, an accusation is often enough to ruin a reputation.  Before this, the teething tablets where Hyland’s best seller and their website claimed it was the #1 oral pain reliever in America, taking a substantial bite out of a 4 billion dollar a year industry (1). 

 

The FDA claims they are investigating 10 deaths and 400 adverse effects including seizures, fever, vomiting from 2010 to 2016 associated with the tablets.   Before you jump the gun and think homeopathy kills people based on this sound bite, I urge you to read what is being said carefully.  Open the articles attached to the headline and you will find that there is actually no cause and effect link made.  The language is very ambiguous and correlational without any specifics.  According to Hyland, as of October 12, 2016, they have still been waiting on any data or evidence proves a causal link between their tablets and the claims that are being made (2). 

 

So, you are reading this and thinking: “So, who cares if there no causal link, what if there is a chance?  Should they not remove them as a precaution anyway?” I would agree with that statement.  However, this is where the mass confusion regarding homeopathy comes into play.  Homeopathic medicine starts with a natural substance which can be toxic in its crude form.  Let’s take Belladonna, the source of all this confusion, for example.  Belladonna is a toxic plant that when someone is poisoned with it, will cause headaches, fever, rashes, dry mouth, delirium and seizures to name a few.  Sounds pretty bad, I know.  However, when this plant is prepared homeopathically, we can use the smallest of doses to actually treat those very things.  It is the principle that homeopathy is based on, called “like cures like.” 

 

When a plant is prepared homeopathically, it is diluted thousands of times before it is made into a remedy. The potency of Belladonna in the tablets is a 12x, which means the amount of Belladonna alkaloids (the active, medicinal part of the plant) in a tablet is 0.0000000000002mg.   As a comparison, the drug Donnatal, an anti-spasmodic that is prescribed for IBS, contains 0.3888 mg of Belladonna alkaloids (3).  Although this is not over the counter, there is no FDA investigation into this drug that contains 1.9 Trillion times the amount of Belladonna alkaloids.  Additionally, the average lethal dose is about 1.27-2.54 mg of atropine, (one of the Belladonna alkaloids) for an average teething-age child (5).  If we where only measuring this alkaloid, this is still roughly 6.5 to 12.7 TRILLION times the amount of Belladonna alkaloids that are in Hyland’s Teething Tablets. 

 

This is why I have said before that it is scientifically impossible for the tablets to cause death.  This is not a therapeutic dose of the plant.  In fact, this is where homeopathy has gotten most of its criticism over the years, but that is another article.   It is not possible for this amount of Belladonna to cause the symptoms claimed, even if the child ate the whole bottle or several bottles. It more likely that a child will develop an allergy to a filler in the product rather than to the Belladonna. As one of the articles I have read boasted that “science has won” this debate, I would like to counter point, that science actually proves these claims to be unachievable by a teething tablet. 

 

What if, however, we do not look at this as a ploy to discredit homeopathy but actually as a misunderstanding?  What if 10 children who took these tablets actually did die?  This may be possible, but it does not mean the tablets caused death.  Statistics 101 tells us we must be aware of correlational data, as it does not prove a causal link.  The famous example of a correlational link is that people eat more ice cream in the summer, and more drowning accidents also happen in the summer.  If you make a causal link, it would look like ice cream causes drowning, which is obviously false.  They both happen in the same environment.  This being said, teething can cause a fever and fussiness, but so do a lot of other things, or at least the start of a lot of other things.  Could it be possible that of the millions of children that used these tablets from 2010 – 2016, that some of them actually were not teething?  That something else was wrong entirely, something that started with a fever and fussiness in a teething child? That they were given the tablets, which did nothing because it was not the right medicine for the child and the natural disease process progressed? This is actually a more likely scenario, knowing what we know now about the lethal dose of Belladonna.  If you look carefully, you will not find any causal claims from the FDA regarding the tablets. 

 

One of the articles written about the teething tablets included a recommendation to give teething children acetaminophen (Tylenol) if needed to ease discomfort.  In order to respond to this suggestion, I am going to take the devil’s advocate argument a step further, and say beyond scientific explanation these claims where true.  How would the suspected deaths from Hyland’s teething tablets compare to accidental deaths from acetaminophen poisoning?  Acetaminophen, when dosed correctly according to weight, should not cause toxicity in most children.  However, if it is not dosed correctly according to time and weight, it can be toxic.  In the United States, acetaminophen toxicity has replaced viral hepatitis as the most common cause of acute hepatic failure (5),  and is actually the number 1 cause of accidental deaths by an over the counter medication in the country (6).  It is the leading call to poison control centers (> 100,000/year) (7) and accounts for 458 deaths/year (7,8).  This is PER YEAR, not TOTAL, by the way.  Therefore, I respectfully disagree with the recommendation to replace the safest over the counter pain reliever with the most dangerous one.  

 

So what is the endgame for these accusations?  I would like to think that it is confusion and a misunderstanding on how homeopathy works.  However, since the FDA regulates homeopathic medicine (9), there should not be confusion regarding the safety and dilutions.   Because homeopathic medicines may be originally derived from a toxic substance, there are harsh regulations in place to ensure that no mistakes are made.  Homeopathic medicine is regulated by the HPUS (the Homeopathic Pharmacopoeia of the United States), and overseen by the FDA.   I feel that homeopathic medicine is the single safest thing that you can put in your body, and I do not feel that way about all natural supplements. Many natural supplements should be managed by a Naturopathic Doctor since they are not regulated and some, when used incorrectly, may cause problems.  We can recommend proper dosing and brands that have been tested to ensure the quality of the product.  However, I can confidently tell my patient to pick up a homeopathic remedy at a health food store, and not be concerned if they dose improperly, because I know that that remedy was made following the HPUS, so I can trust the quality and safety.     

 

So why do I care so much?  Why did I write this manifesto that I hope you are still reading?  Well, this is what I do, it is what I have devoted myself to: helping people find healthy alternative options to heal. When there are unsubstantiated claims, headlines and sound bites that attempt to discredit that option for my patients, you bet I am going talk about it.  Secondly, we all deserve better that this.  We deserve to make educated choices about our and our children’s health based on facts and not fear.  While Hyland was forced to remove their products, homeopathy has not lost if the right information continues to circulate.  Finally, FDA, please leave homeopathic medicine alone, as it does not even come close to all the actual poisons you allow in our foods and drugs.

 

(1)   http://www.chpa.org/OTCsCategory.aspx

(2)   http://www.hylands.com/media/press-release/hylands-affirms-safety-its-products-still-awaiting-data-behind-fda-warning

(3)   http://www.rxlist.com/donnatal-drug.htm

(4)   Natural Standard Herb & Supplement Guide: An Evidence-Based Reference, Ulbricht, Catherine, 2010. Pages 98-99

(5)   http://emedicine.medscape.com/article/820200-overview

(6)   https://uanews.arizona.edu/story/poisoning-the-no-1-cause-of-unintentional-death-in-the-u-s

(7)   https://www.ncbi.nlm.nih.gov/pubmed/15239078

(8)   http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf

(9)   http://www.chpa.org/homeopathic.aspx