Hundreds of Babies Harmed by Homeopathic Remedies, Families Say

Feb 24, 2017

By Sheila Kaplan

WASHINGTON — Case 7682299: Aug. 1, 2010. A mother gives her toddler three homeopathic pills to relieve her teething pain. Within minutes, the baby stops breathing.

“My daughter had a seizure, lost consciousness, and stopped breathing about 30 minutes after I gave her three Hyland’s Teething Tablets,” the mother later told the Food and Drug Administration. “She had to receive mouth-to-mouth CPR to resume breathing and was brought to the hospital.”

The company, Hyland’s, promotes “safe, effective, and natural health solutions” that appeal to parents seeking alternative treatments. But the agency would soon hear much more about Hyland’s teething products. Staff at the FDA would come to consider Case 7682299 one of the luckier outcomes.

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9 comments on “Hundreds of Babies Harmed by Homeopathic Remedies, Families Say

  • Here’s the thing, homeopathy should be immune from this claim because it is WATER in the capsules. Here’s a cut from the manufacturer’s website:

    As a manufacturer of homeopathic medicines, and as parents ourselves, we want to share with you how Hyland’s Baby Teething Tablets are made and what they contain to effectively and safely alleviate your child’s teething aches and pains.

    First and foremost, the quality of homeopathic medicines manufacturing is regulated by the Food and Drug Administration (FDA), as required in the Federal Food, Drug and Cosmetic Act. The production of Hyland’s homeopathic medicines occurs within a validated process, as with any FDA-regulated drug, to ensure an accepted level of consistency in product output.

    "The amount of Belladonna alkaloids in teething tablets is minuscule....
    thousands of times below even the therapeutic amounts of Belladonna used in conventional anti-spasmodic medicines..."

    Hyland’s Teething Tablets contain homeopathically prepared forms of Calcarea Phosphorica, Chamomilla, Coffea Cruda, and Belladonna. These ingredients are all prepared in accordance with the Homeopathic Pharmacopoia of the United States (HPUS). HPUS has been recognized by the FDA since 1938 as the official compendium (or formula book) for homeopathic medicine in the U.S. When homeopathically prepared, active ingredients are diluted to the point that the risk of toxicity is extremely low (see specific details below).

    Calcarea Phosphorica is included in Hyland’s Teething Tablets for its ability to support teeth formation. Chamomilla is included in the Tablets for its actions on irritability commonly associated with teething pain. Coffea Cruda is included in the Tablets for its actions on wakefulness and increased urination.

    "...a 10-pound child would have to accidentally ingest, all at the same time, more than a dozen bottles of 135 Baby Teething Tablets before experiencing even dry mouth from the product."

    So, they are telling you right there, right up front, that in order to havew ANY MEASURABLE EFFECT WHATSOEVER, a TNE POUND child would have to take 12 X 135= 1620 capsules.

    Why is this not a clear red flag or smoking gun as to the product being abject bullshit!. I weigh two sixty. I’d have to take 12 X 135 X 26 =42,120 capsules to get dry mouth, let alone any therapeutic value.

    Why do these remedies persist?



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  • Here’s the next paragraph from the manufacturer’s site:

    Belladonna is included in the Tablets to ease the redness, inflammation and discomfort of the child’s gum that often occurs during the teething process. Belladonna 12X HPUS is manufactured from the whole plant, of which a small portion is Belladonna alkaloids (the component sometimes associated with side effects). Each Teething Tablet (which weighs about 65 mg) is composed of 0.0000000000003% Belladonna alkaloids as stated on the label. As calculated, this means that each complete teething tablet contains only approximately 0.0000000000002 mg of Belladonna alkaloids.

    The amount of Belladonna alkaloids in teething tablets is minuscule, especially when compared to conventional medicines that contain Belladonna alkaloids. To put the calculated amount of Belladonna in a Hyland’s Baby Teething Tablet into perspective, the 0.0000000000002 mg of Belladonna alkaloids is THOUSANDS OF TIMES below even the therapeutic amounts of Belladonna used in conventional anti-spasmodic medicines that doctors sometimes prescribe (0.2 to 5 milligrams of Belladonna alkaloids). The side effects (called anticholinergic side effects) sometimes caused by conventional medicines delivering more than 0.2 mg of Belladonna alkaloids – such as dry mouth, blurred vision and urinary retention – are not associated with homeopathic medicines because of their minute dosage.



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  • @OP link – In investigating Hyland’s teething products, the FDA focused on an ingredient known as atropa belladonna, an herb
    known colloquially as “deadly nightshade.”

    At a very early age, this was a wild plant I was taught by my scientist father to avoid.

    In diluted form, the substance is not expected to pose any health risk. In 2010, however, FDA inspectors who examined Hyland’s facilities criticized the company for substandard manufacturing practices and found inconsistent levels of atropa belladonna in its products.

    The agency issued a public warning, noting
    “reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.”

    This is not a plant for incompetent amateurs to be messing with!

    http://www.thepoisongarden.co.uk/atoz/atropa_belladonna.htm

    Common Names and Synonyms

    deadly nightshade, dwale, devil’s herb, love apple, sorcerer’s cherry, witches berry, divale, dwayberry.

    This is the true ‘deadly nightshade‘.
    Some Americans insist on calling Solanum dulcamara by that name rather than woody nightshade or bittersweet. There are many images on the Internet of Solanum dulcamara flowers labelled ‘deadly nightshade’.

    With wild herbs, there is also the issue of incompetence in identification of plants, leading to variations in any extracts from them.
    Checking the “safety” of the wrong plant, is very dangerous if harvesting is mixed, or people lacking botanical identification skills are reading recipes in books!

    How Poisonous, How Harmful?

    Contains tropane alkaloids, notably hyoscine (also called scopolamine), hyoscyamine and atropine.
    At least five other toxic components have been isolated.

    Symptoms may be slow to appear but last for several days.
    They include dryness in the mouth, thirst, difficulty in swallowing and speaking, blurred vision from the dilated pupils, vomiting, excessive stimulation of the heart, drowsiness, slurred speech, hallucinations, confusion, disorientation, delirium, and agitation. Coma and convulsions often precede death.

    There is disagreement over what constitutes a fatal amount with cases cited of a small child eating half a berry and dying alongside a nine year old Danish boy who, in the 1990s, ate between twenty and twenty five berries and survived.

    A 1996 study of plant poisoning over 29 years in Switzerland found that Atropa belladonna had caused more serious incidents than any other plant (though less than 2 per year on average) and none of these resulted in death.

    Though the root is believed to have the highest concentration of the toxins, the berries are usually the cause of accidental poisoning because they look so nice.



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  • Further to my comment @#3 –

    With wild herbs, there is also the issue of incompetence in identification of plants, leading to variations in any extracts from them.
    Checking the “safety” of the wrong plant, is very dangerous if harvesting is mixed, or people lacking botanical identification skills are reading recipes in books!

    In genera which contain alkaloids, there can be considerable variation in content and concentration, between different species, sub-species, and varietal forms, and in different parts of the plants!

    Where plants have evolved chemical defences, there can also be a range of different toxins at varying concentrations in different plants (according to growing conditions) and in the various sub-species.

    Botanists use binomial Latinised names because the use of the variety of different local plant names for the same plant, leads to confusion!



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  • NorthernVoice #5
    Feb 24, 2017 at 9:34 pm

    As long as the “remedies” are prepared correctly, babies are more likely to suffer harm from the lack of real treatment.

    As is indicated in the OP and as I indicate @#3 and #4, the problems in this case appear to be:-

    a) The hugely variable sensitivity of different people to the poisons. – so there is no “one size fits all correct dose”!

    b) Any use of dangerous drugs should be prescribed and supervised for adverse effects or side effects, by competent medical staff.

    c) In getting the dilutions of the poison they are seeking, there may be several other poisons which are more concentrated in the plant which are overlooked.

    d) The effects may be magnified by a mix of chemicals. – Plants would tend to evolve such combined increased effectiveness of their defences.

    e) The so-called medicines are not rigorously tested for safety and effectiveness.

    f) The standards of the batches of ingredients are not properly measured and monitored.

    g) The chemical content varies from plant to plant.

    h) Quackologists should not be playing with these sorts of dangerous materials, and regulatory bodies should have, and be exercising, the powers to close them down!

    i) While describing products as homeopathic, they quite often have significant concentrations of active herbal ingredients.



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  • Alan @ #6

    All your comments would certainly be true for any real attempt at medication created to administer an actual dose of the original agent. My understanding of homeopathy is that they use such a vast dilution series in preparing their little pills that dose just isn’t a issue. They dilute way past Avogadro’s number, to the point where there is only a tiny chance of even one molecule of original agent showing up in the pills (and then they blather total nonsense about “molecule impressions and memory” as a treatment). If my understanding of the degree of their dilution series is correct, it wouldn’t matter if you started with VX nerve gas … except for spin problems in the marketing of your product that is ;P



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  • NorthernVoice #7
    Feb 25, 2017 at 7:47 am

    Alan @ #6

    All your comments would certainly be true for any real attempt at medication created to administer an actual dose of the original agent. My understanding of homeopathy is that they use such a vast dilution series in preparing their little pills that dose just isn’t a issue.

    That is true IF homeopathic rules are followed and the process is competently carried out, but as with many forms of quackery, honesty is not a priority, and in arguments with homeopath enthusiasts, I have been referred to links to labelled “homeopathic remedies” supposedly proving their effectiveness, only to find on further investigation that the “effectiveness” was due to significant herbal content, and not to ultra-dilution!
    With quacks, actual competency (rather than their own wishful perceived competence), is also an issue!

    Many are full of profound ignorance and self delusion! – Rather like the boy racer with no driving licence, who foresees no risky problem with his illegal driving, because he would score zero on the hazard-perception test!

    It should be evident in the OP example that for whatever reason, toxicity of the product is an issue.



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  • Wow, this is embarrassing. A Homoeopathic Remedy that actually has some effect!!! One that (apparently) actually contains some of the stuff listed on the label!!!.

    On the bright side, looks like it proves Homoeopathy actually works (maybe not as intended, but hey, at least it’s been reported as Doing Something).

    I’m picking that the Homeoeopathic thing is a red herring. Many foods and medicines have caused harm over the years, some by contamination accidental or deliberate (melamine in baby milk, anyone remember that one?), by faulty manufacture, or by failures in the pre-market trials phase (thalidomide?).

    So, this particular “remedy” is tainted with poison. Bad for the unfortunate consumer, bad for the manufacturer, but not so bad for the entire industry, is it? Other makers of H…. stuff can claim (quite rightly, if they’re manufacturing as they claim) that their products contain Nothing Harmful Whatsoever.

    But wait, wouldn’t that mean they were admitting there was Nothing in them?

    Like I said, embarrassing.



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