W

ASHINGTON — 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.”

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    • Walter said:

      “Homeopathics work and are a threat to the pharmaceutical industry. PERIOD.”

      Well, they might be if there was a jot of good evidence they were effective – do you have any?

      “The Swiss recently endorsed homeopathic medicine as a cost-effective healing modality.”

      No, no they didn’t.

      “Why did children only die in the U.S.? Because the FDA—big pharma’s SS unit—had to find a way to discredit homeopathic medicine.”

      Alternatively, Hyland’s manufacturing and QA controls are shoddy. Besides, Standard Homeopathic is a US company that sells predominately in the US. They certainly have no registered or authorised products in the UK.

    • Standard Homeopathic/Hyland’s also sells its products in Canada and Australia. Canada Health has stated that it has received no adverse events reports on teething tablets and does not agree with the FDA that they are not safe. I haven’t seen any comments one way or the other from the Australian authorities.

      healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/60634a-eng.php

    • Christine said:

      “Standard Homeopathic/Hyland’s also sells its products in Canada and Australia. Canada Health [sic] has stated that it has received no adverse events reports on teething tablets and does not agree with the FDA that they are not safe. I haven’t seen any comments one way or the other from the Australian authorities.

      healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/60634a-eng.php”

      Well, that’s not at all what that link says now, is it?

    • ChristyRedd said
      “…Canada Health has stated that it has received no adverse events reports on teething tablets…”

      Christy I don’t get you. These are Trumpian standards of untruth

      They said there have been 11 adverse event reports, three of which they discount, leaving eight.

      You do your cause no good whatsoever by telling lies.

    • Shame on you Alan and Steve! This is what Health Canada said regarding Hyland’s teething products:

      “At this time there is no indication of a similar safety concern (to the warning put out by the FDA) in Canada.”

      There are other manufacturers of these products in Canada. Health Canada stated about their products:

      “There are several homeopathic teething products authorized in Canada manufactured by different companies….Health Canada has received 11 Canadian adverse reaction reports involving a variety of these products since their sale: three that were serious but were confirmed, following an assessment, to be UN-related to the products; seven that were serious and one that was an allergic reaction that was determined to be possibly linked to the product. No deaths associated with homeopathic teething products have been reported in Canada.”

      If the link doesn’t work, put it in your browser. No one has to accept my word or the interpretation of “skeptics” for Health Canada’s stand.

      http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/60634a-eng.php

  • As those familiar with homeopathy know, homeopathic medicine is so uber-diluted as part of the homeopathic process that in general, if chemical tests are done on the medicine, the active ingredient can’t be identified. So if belladonna was actually detected in a homeopathic tablet, it sounds like something happened during manufacturing. This points to possible issues with good manufacturing practices, not with homeopathy itself.

    Also, I’m very sorry about the baby who died, but it’s considerably more likely that the baby died due to being left alone with a bottle (and then vomiting and aspirating), than that the vomiting was due to a homeopathic substance.

    There is clearly something to be looked into here. But I suspect that if one compared the number of adverse effects of any kind per patient from homeopathic medicine with the huge number of adverse events and deaths due to “regular” drugs, there’d be no contest.

    • Chemical tests are not used to analyze homeopathic medicines and were not used in the FDA’s analysis. Spectroscopy was used. It could detect no belladonna in some of the samples. In others the level fell below the limit of quantification. In some samples the levels ranged from 0.1 to 53.4 nanograms; that is, 0.1 to 53.4 billionths of a gram of substance. These are homeopathic dosages and fall within the safety range.

    • Betsy Todd RN said:

      “Also, I’m very sorry about the baby who died, but it’s considerably more likely that the baby died due to being left alone with a bottle (and then vomiting and aspirating), than that the vomiting was due to a homeopathic substance.”

      Why do you say that?

    • The manufacturing, labeling, marketing and sales of homeopathic products have been subject to FDA guidance and compliance since 1938.

      And yet when the FDA actually act within the bounds of their mandate homeopathy supporters get all pissy about it.

  • Press-titutes—whores disguised as journalists—who publish vaccine-industry PR articles and press releases as “investigative journalism”.

    • The eloquence with which you counter the mis-information presented in this article is astounding. The facts. The research. The clear, undisputable trail of evidence… You truly have the investigation skills that match any alt-med supporter.

    • It really was quite extraordinary how Ullman managed to get so much wrong in one article.

      Ha! No, it wasn’t. 🙂

    • …the Federal Office of Public Health FOPH decided to publish a letter in the Swiss Medical Weekly, pointing out that “This review was declared to be an HTA by the authors (the final PEK [5] report does not classify the literature reviews as HTA reports) and published later as a book [7] under their responsibility without any consent of the Swiss government or administration. The book by Bonhöft and Matthiessen was later translated into English and published in 2012”.

    • Homeopathy was approved for OTC sales by the FDA in 1938 based on its 200+ years of clinical use showing that it has an overwhelming safety record. Conventional drugs, on the other hand, have been shown to create disease and often result in death. They are also the number one cause of personal bankruptcy in the U.S.

      Homeopathy is not only safe but also effective as is shown by the study Dr. Malik posted. The study reads: “Compared with anti-bacterials, Sinfrontal (a homeopathic product used in Germany to treat ear, nose, throat and respiratory conditions) had a significantly higher cure rate (11% vs. 59%; p 0.001) at similar or lower costs.” Could this be a reason for the attacks on homeopathy we see around the world?

      Again, the FDA analysis of Hyland’s teething products showed no toxic levels of belladonna in the products.

      https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm538669.htm

    • Again, the FDA analysis of Hyland’s teething products showed no toxic levels of belladonna in the products.

      https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm538669.htm

      How do you not get it? This is from the link you just gave. Do you not read your references or do you just not understand it?

      “Inconsistency in levels of belladonna, a toxic substance, signals a poorly controlled manufacturing process and poses an unnecessary risk to infants and children under two years of age.

      Certain homeopathic teething products are manufactured to contain a very small amount of belladonna and other ingredients. Ordinarily, such low levels would not be readily detected by even highly sensitive testing methods, including those used by FDA at its laboratories.

      Therefore, FDA’s analysis should not have found any detectable belladonna in these products. ”

      Key points:

      * This crap is given to babies.
      * This crap made from poison.
      * This crap should not have had detectable amounts of poison in it.
      * This crap did have inconsistent levels of poison in it.

      So, given there shouldn’t have been any poison and there was do you not think it is the prudent thing to do to err on the side of caution?

      Think of the children.

    • Once again, Gold………..

      Read the FDA’s analysis. It shows that some of the tablets contained between 0.1 and 53.4 NANO-grams of belladonna. That is 0.1 to 53.4 billionths of a gram of substance, a homeopathic dose and very far from a toxic dose. The FDA approves Donnatal which contains scopolamine 0.0065 MILLI-grams, atropine sulfate 0.0194 MILLI-grams and hyoscamine sulfate 0.1037 MILLI-grams.

      “Skeptics” have claimed for years that homeopathy can’t possibly do anything because it’s “just water” or because “there’s nothing in it”. Now you claim homeopathic doses cause seizures and death, something the evidence does not support. You can’t have it both ways.

    • @Christine

      It’s difficult to comprehend how anyone could have so much trouble understanding this but please tell us: what are the maximum amounts of Scopolamine and Atropine that will be present in all tablets produced by Hylands?

    • “Inconsistency in levels of belladonna, a toxic substance, signals a poorly controlled manufacturing process and poses an unnecessary risk….”

      In some cases it may, but not in this one, because the variation is all well within the range of safety. All facets of GMP, including precision, are not ends in themselves, or they’d be mere fetishes. Rather, they’re to serve goals — in this case, the goal of safety, and that goal is achieved by the degree of precision seen here.

      That’s not to say nothing else went wrong in the manufacturing of this product. We might get some idea whether something went wrong if we had more info from both FDA and the manufacturer. The manufacturer could tell us the number of units of those batches sold, so we could see whether statistically the number of complaints is just as likely to have occurred by chance, and FDA could release the case reports, so we could determine whether there was any pattern to the nature of the complaints. It should be easy to anonymize the case reports sufficiently for privacy concerns; I’ve done that myself in papers for publication.

    • “what are the maximum amounts of Scopolamine and Atropine that will be present in all tablets produced by Hylands?”

      Assuming the sampling in the report to have been random, one could take the results as a t distribution, and from that calculate the chance of any given amount’s occurring in a bottle or pill. Taking the size of the production run, one could then calculate the odds of its including a pill exceeding any stipulated limit.

    • Once again, Gold………..

      Ellipses of emphasis!

      Read the FDA’s analysis. It shows that some of the tablets contained between 0.1 and 53.4 NANO-grams of belladonna.[irrelevant stuff snipped because it’s irrelevant]

      * This crap should not have had detectable amounts of poison in it.
      * This crap did have inconsistent levels of poison in it.

      Regardless of how much was actually found how can you not read this and realise that Hylands manufacturing and quality control process was substandard?

      The fact that nothing should have been detectable and something was detectable leads to the reasonable conclusion that there is the potential for too much to eventually end up in a bottle at some point. And for at least 10 times to date, it appears it has.

    • “Regardless of how much was actually found how can you not read this and realise that Hylands manufacturing and quality control process was substandard?”

      It may well have been, but do you know what standard it was sub? It may have failed the monograph — I don’t know what the monograph for this article in the HPUS specifies — but still, it failed safe.

      “The fact that nothing should have been detectable and something was detectable leads to the reasonable conclusion that there is the potential for too much to eventually end up in a bottle at some point. And for at least 10 times to date, it appears it has.”

      No, that’s not a reasonable conclusion. “Potential” compared to what? What makes you think there was any greater potential for it to happen by them than by any other mfr.? And if the amount by which it’s “too much” is still never dangerous, who cares?

      One thing they could do would be to increase their claimed tolerances (assuming still within the bounds of the monograph). There, now they’re within them. What difference does that make?

      There are all sorts of possibilities to account for the adverse events. In some of them Hyland’s is at fault, in others FDA is, and in still others there was no fault. I know of many cases of products being blamed for injuries that they did not cause.

      There is still the possibility that the cases herein WERE (or included) ones of actual belladonna poisoning that FDA’s testing did not bring out, because of a systematic error rather than a random one. I was called in once to investigate why different labs engaged to assay a client’s iodinated glycerol product were giving inconsistent results; my investigation showed that the labs were not at fault, but that they had received samples prepared differently. Another time I was tasked with investigating why inconsistent results were being gotten from an endotoxin test of hemodialyzers; in that case it turned out that different elution procedures were being used because of an incorrect assumption somewhere up the line of SOP transmission. So in this case it could be that someone at Hyland’s did something different in making certain marketed pills than they had done in the batches FDA wound up sampling.

      Another possibility is that a hitherto unknown toxicant that nobody could’ve known to assay for was responsible, as was the case with some contaminated tryptophan.

      Another possibility is that it’s just chance; in a large enough population of kids in a given amount of time, some are going to get sick regardless of what they’d done.

      Or it could be voluntary manslaughter by some villain, as in the Tylenol poisoning case.

      The one thing that HAS been ruled out by FDA’s testing is random error resulting in poisoning by overdose.

    • “The fact that nothing should have been detectable and something was detectable leads to the reasonable conclusion that there is the potential for too much to eventually end up in a bottle at some point. And for at least 10 times to date, it appears it has.”

      No, that’s not a reasonable conclusion. “Potential” compared to what?

      Stupid question. Please look up the definition of “potential”. The grammar on your question is also… questionable.

      What makes you think there was any greater potential for it to happen by them than by any other mfr.?

      Irrelevant diversion. Other manufacturers aren’t part of this story. I also have no expectation to think that other manufacturers are any better or worse. The quality of other manufacturers are processes speaks nothing at all towards the quality of Hylands manufacturing process, which, it has been found, is inconsistent.

      And if the amount by which it’s “too much” is still never dangerous, who cares?

      Who care if an inconsistent amount was detectable when the proper manufacturing process should have resulted in none being detectable at all? The parents, friends and families of 10 dead kids so far. You’re understanding of statistics is non-existent. That is self-evident from your responses here.

      I, and many others, regularly get accused of being shills for “Big Pharma” like it is a single overarching boogyman organisation.

      Here we have a case where a single, specific company, Hylands, has been found to have shoddy manufacturing processes and instead of the Homeopathy supporters claiming that it’s the company at fault, not homeopathy, the vast majority run to the companies defence. This sort of behaviour is exactly the sort of thing you’d expect to see from a “paid shill” for Big Water.

      I don’t for a moment believe that that is the case. I have no evidence for it and you’re all crazy.

  • The U.S. is the only country whose drug monitoring agency has made the “inconsistent” minute amounts of belladonna in the Hyland’s tablets such a big over-blown issue. There are other effective teething aids for sale without belladonna, by both Hyland’s and Boiron. In fact, Walmart has recently announced that they carry many Boiron homeopathic products. The anti homeopathy crowd can stop celebrating now.

    • Anne said:

      “The U.S. is the only country whose drug monitoring agency has made the “inconsistent” minute amounts of belladonna in the Hyland’s tablets such a big over-blown issue.”

      Well, maybe they’re the only ones who have checked and found the manufacturer’s production/QA controls to be shoddy? But your apparent lack of concern about the possible harms causes is worrying. Are all homeopathy fans this indifferent?

      “There are other effective teething aids for sale without belladonna, by both Hyland’s and Boiron. In fact, Walmart has recently announced that they carry many Boiron homeopathic products. The anti homeopathy crowd can stop celebrating now.”

      Effective? Why would you say that?

  • ChristyRedd:

    You misunderstand me. I am suggesting that the company is not being honest when they claim 12 x and in fact a more allopathic dose is sneaking in there sometimes.

    I’d like to see some studies of trustworthy homeopathic meds in pubmed before I’ll believe a truly homeopathic remedy works. I also see a lot of non-homeopathic doses in homeopathic remedies. So which is working, the homeopathy, the placebo effect, or the other ingredients? Just comments.

  • The FDA analysis showed at most 1.1 microg. atropine in a tablet, which is far from enough to produce the problems reported. It does show great variation in quantities, which I suspect is inherent in the cumulation of errors by doing serial dilutions, and not from a defect in manufacturing. If the reported distribution in amounts per tablet were projected to an entire production run, could the high-end tail of the curve even approach quantities that would be allopathically (as homeopaths would refer to it) significant? I doubt it.

    What I’d like to see is the case reports. Are they consistent with there being any single pharmacologic explanation? The pupil dilation mentioned in one case in the story would be consistent with belladonna poisoning, but is also seen in other situations of a patient’s undergoing death; even someone dying from overdose of a cholinomimetic agent, which would shrink the pupils, will eventually have dilated pupils as well. If this preparation was responsible for deaths and other adverse events, have other contaminants been excluded as causative?

    In any large enough sample of persons, over a given time some will die. Has anyone supplied statistics to compare the number of deaths between patients dosed with, and not does with, this drug?

    • Robert Goodman,

      Thank you for your contribution to this discussion.

      My understanding is that the FDA has not provided Hyland’s with any details about the cases in question despite having been asked to do so. In fact, these cases are apparently the same cases which the FDA brought up in 2010. At that time it stated “Adverse events have been reported, but the FDA has said that a conclusive link to Teething Tablets has not been determined.”

      https://www.fda.gov/Safety/Recalls/ucm230769.htm

      Many of us question whether or not there were other etiologies for these cases including vaccination.

      Hyland’s is a highly experienced and respected company and has sold these teething products here in the U.S. with great safety for more than 75 years. They also sell them in Canada. Canada Health has stated that it has not received adverse events reports and does not consider the product unsafe.

    • Christine said:

      “these cases are apparently the same cases which the FDA brought up in 2010.”

      How odd you should think that…

      The article says:

      “Over a 10-year period, from 2006 to 2016, the FDA collected reports of “adverse events” in more than 370 children who had used Hyland’s homeopathic teething tablets or gel, a similar product that is applied directly to a baby’s gums. ”

      and:

      “In case 462749, dated Sept. 15, 2011, a physician sent Hyland’s a handwritten note, stating his patient, a 5-month-old girl, was unresponsive for 45 minutes after taking its teething tablets.”

    • Christine said:

      “Regarding the doctor’s note on case 762749 I must remind you that correlation does not equal causation.”

      Do you know of any good manufacturers of robust irony meters?

      “I’m quite sure the doctor would not have stated “baby just received vaccination” unless he wanted to give up medicine.”

      Why would you suppose that?

      “You have undoubtedly used the phrase “correlation does not equal causation” many times yourself, haven’t you?”

      When chatting to homeopathy fans, all the time. Hence my sudden need to use my fire extinguisher on my previously trusty meter.

      “Being a UK citizen you wouldn’t know how deaths are handled here in the U.S.”

      Why on earth would you suppose that?

      “Unexpected or sudden deaths are not investigated by doctors. A doctor’s opinion would not be accepted in determining cause of death. These types of deaths are investigated by medical examiners who autopsy the body, perform an inspection and tests and often use forensic methods to come to an accurate understanding of what the cause of death actually was.”

      Have you thought of writing a script for NCIS? I’m sure they’d welcome your insight.

      “Good of you to acknowledge that some of the cases under discussion today go back to 2010.”

      I never made any claim about that but good of you to acknowledge you were completely wrong about the cases being the ones the FDA brought up in 2010. You could have saved yourself the embarrassment of being shown to be wrong again by simply reading the article, though. But maybe you’re inured to being shown to be wrong?

    • Alan,

      This is most likely over your head, but I’ll post it anyway. He who diligently searches for truth must recognize that he himself is not truth.

    • Christine said:

      “This is most likely over your head, but I’ll post it anyway. He who diligently searches for truth must recognize that he himself is not truth.”

      ROFL!

      But any time you want to admit either you don’t understand the FDA data or that you are blithely unaware of its implications, please just say so.

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