As has been repeatedly pointed out on this blog, homeopathy is an elaborate placebo system, with most remedies diluted so greatly that not a single molecule of the original material remains. The final product sold to consumers is quite literally, water – drops of which are dried on sucrose or lactose tablets. The fact that homeopathy has not been shown to be more effective than placebo should surprise no-one: it is a placebo, and the positive effects reported are placebo effects.
Because there are no medicinal ingredients, there is no way to take a typical homeopathic remedy and, by testing it, determine which remedy it’s supposed to be. All you would find would be sugar. That’s why Health Canada doesn’t require any post-manufacturing quality testing of the remedies it deems “safe and effective” – there’s nothing that can be objectively measured. So whether it’s lead, rabbit vagina (really), or the liver and heart of a duck, once they’re diluted enough, there’s nothing to distinguish one homeopathic remedy from another. Yet each approved product is granted a unique license number by Health Canada.
Homeopathy’s lack of active ingredients gives the products a reasonable safety profile. After all, a product can’t cause side effects, if it doesn’t cause any effects at all. So you can take plutonium, dilute it enough, and you won’t get radiation poisoning. But when a homeopathic remedy isn’t diluted enough, you can be exposed to the initial substance, which can be toxic. Enter Hyland’s Teething Tablets, and a recent warning from Health Canada:
Hyland’s Homeopathic Canada (Hyland’s), a division of Standard Homeopathic Company, in consultation with Health Canada, is voluntarily recalling its Hyland’s Teething Tablets from the Canadian market because they may pose a risk to children, according to U.S. Food and Drug Administration (FDA) testing. This recall has been initiated in both Canada and the U.S. as a precautionary measure due to the FDA’s ongoing inspection of Standard Homeopathic Company’s manufacturing facility in the U.S. Hyland’s Teething Tablets are manufactured in the U.S. and distributed throughout North America, including Canada.
Hyland’s Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled.
The FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity but conclusive links have not been formally determined.
Let’s look at the ingredients. The product is listed in Health Canada’s Natural Health Products Database as “Hyland’s Kinder T” (search NPN/DIM-HM 01956485 here)
The ingredients, as approved by Health Canada, and as listed on the manufacturer’s website, are:
Calcarea Phosphorica 3X HPUS – supports dentition
Chamomilla 3X HPUS – for irritability
Coffea Cruda 3X HPUS – for wakefulness and diuresis
Belladonna 3X HPUS (0.0000003% Alkaloids) – for redness and inflammation
In a base of Lactose (milk sugar) NF.
Here’s a translation from the homeopathic bafflegab:
Calcarea Phosphorica Calcium phosphate, diluted 1 part in 1 thousand.
Chamomilla German chamomile, diluted 1 part in 1 thousand
Coffea Cruda Coffee, diluted 1 part in 1 thousand
Belladonna Deadly nightshade, diluted 1 part in 1 thousand
In a base of Lactose (milk sugar) NF. The diluted liquid is dripped on sugar tablets and dried.
So under normal circumstances, when prepared according to the label, each tablet may give trace amounts of calcium, chamomile plant, coffee, and a highly toxic alkaloid. None of the ingredients have any demonstrated efficacy for teething. But if you give a non-homeopathic dose of belladonna, here’s what the side effects could include:
Fever, rapid pulse, dilation of pupils, hot and dry flushed skin, headache, dry mouth, difficulty of swallowing, burning of the throat, hallucinations, convulsions. Highly toxic, may be fatal if eaten.
The recall raises more questions than answers, from my perspective:
- What evidence exists to demonstrate that Hyland’s Teething Tablets have effectiveness superior to a placebo? There does not appear to be any public information that demonstrates it is effective. Health Canada has approved it as a “homeopathic remedy”. So why is it advertised for teething, and what is the basis for this approval?
- Given belladonna has been associated with severe adverse effects, and has not been shown to have any beneficial effects for teething, why is it being permitted, at any concentration, in a product given to infants?
- There is no infant dose approved by Health Canada: only an adult dose is listed. Why is the marketing for use in infants permitted by Health Canada?
- Health Canada warns users, “Contact a health care practitioner before use if pregnant or breastfeeding, or if symptoms persist for more than 7 days or worsen.” If health care consultation is required if someone is pregnant or breastfeeding (and apparently teething, too), why is it felt to be acceptable to give this product directly to infants?
There’s no clinical rationale for the combination of ingredients in Hyland’s Teething Tablets, nor is there any scientific information to support its use in infants. The product is essentially a sugar pill, possibly with a few molecules of ingredients, some of which have been demonstrated to be toxic at higher concentrations. There is no benefit that one can expect from Hyland’s Teething Tablets, recall or not, and it has no place in the science-based pharmacy.
Update: 14 Nov 2010: Dilutions corrected