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.”

This is a STAT Plus article and you can unlock it by subscribing to STAT Plus today. It's easy! Your first 30 days are free and if you don't enjoy your subscription you can cancel any time.
Already a subscriber? Log in here.

Leave a Comment

Please enter your name.
Please enter a comment.

  • Ok, so the FDA can come down on a homeopathic “drug” for 10 deaths but not come down on vaccines that have much higher mortality rates? That makes no sense.

    • If you look at the risk:benefit ratio vaccines do more good than harm.

      Something like homeopathy that has no demonstrable good at all will always come out poorly on that ratio. And when you now add “potential death” to the list of risks for something that typically claims 100% safety and no side effects…

      That makes no sense.

  • Homeopathic preparations should clearly be subject to the same regulations as medicines. They should go through pre-clinical(animal studies) and full clinical trials and before they are allowed to be sold to the public. This should be the case for each individual product.

    Clinical trial are in stages:

    Phase 0: trials on a small 10 to 15 subjects to confirm that the products interactions within the body appear to be as expected.

    Phase 1: trials on small group of subjects (20–80) to evaluate safety, determine safe dosage ranges, and begin to identify side effects.

    Phase 2: Testing with a larger group of people (100–300) to determine efficacy and to further evaluate its safety. The candidate product will often be tested against a placebo.

    Phase 3. Testing with large groups of subjects (1,000–3,000) to confirm products efficacy, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.

    At this stage the product can be licensed for use.

    There should be ongoing Phase 4 studies once the product is in use to gather additional information, including products risks, benefits, and optimal use.

    There should as part of Current Good Manufacturing Practices be regular audits of Production records and spot checks on product containers and closures, including testing for microbiological contamination.

    The initial costs of the clinical trials would be met by the manufacturer and then passed on to the customer. Full clinical trials are expensive, though if at stage 2 it had not been possible to determine efficacy there would be little point in continuing as the product would not be approved.

    • Depends what you mean by “clearly should”; do you mean it in a normative sense or do you mean as an interpret’n of US law? If the latter, you’re probably wrong but there’s an argument that you’re right.

      Congress in enacting food & drug laws, and states in their pharmacy laws (mostly boilerplate), created a separate category generally called by analysts “official articles” that include drugs those articles specified by any of a short list of compendia which are maintained by private bodies. The major one is now called USP-NF, formed by the merger of two of them, and many government officials sit on their board, although it is still independent of direct gov’t control, although each was founded by gov’t agencies. The other, the Homeopathic Pharmacopeia of the US, was added to the federal statute by amendment in 1938, and these days I don’t know of any gov’t officials on the board of the Homeopathic Pharmacopoeial Convention of the US.

      In both federal & state laws, an article is defined as statutorily a “drug” if it EITHER fits a certain description of its “intended” use OR has a monograph in one of the compendia. So, for instance, cannabis today is no longer treated as a “drug” in US law because it was removed from the USP by their board’s convention. Nothing explicit in the statutes says something that qualifies as a “drug” by being an official article is not subject to the same provisions as an article of commerce that qualifies as a “drug” by the other statutory definition, so there are some who argue as you do that newly entered HPUS articles are apparently subject to the same provisions you listed above for “new drugs”.

      However, such has not been the case. When the safety and efficacy provisions of the drug laws were put in place, the general understanding was that the governing bodies of the official compendia were an adequate substitute for the advisory panels FDA convenes ad hoc to decide on licensing new drugs. It was not believed that the official compendia would be a major point of entry of new drugs, and indeed they have generally lagged behind FDA panels in their examination of articles. Not only that, but the overwhelming majority of new drugs has been proprietary, sponsored under a brand name, rather than as new compositions submitted generically, as they would be identified in one of the official compendia. Basically the bodies governing the compendia want to (always wanted to) see what gained & maintained acceptance by medical practitioners.

      In order for the HPCUS to have much to do these days, they’re forced to not limit themselves to looking at “new drugs” as introduced into the US market by other means, but to look at evidence from homeopathic provings as their trials. The inclusion of the HPUS in state & federal drug laws carries the implication that these will continue to go on outside of the channels used by “allopathic” drug development.

    • Depends what you mean by “clearly should”

      The use of “clearly should” in Adrian’s comment does not need to be encumbered with any further “clarification”.

      It stands on its own merit.

      What Adrian describes is very clear.

      As with anything science related politics shouldn’t come into it. Science can inform politics, but that should never go in the other direction.

  • I’ve never had an issue with these with my son, who is now six. I find it a bit amusing that the FDA states this because of belladonna but laughs off people’s concerns about deadlier ingredients in vaccines and other drugs.

    • I’ve never had an issue with these with my son, who is now six.

      That makes you lucky.

      I find it a bit amusing that the FDA states this because of belladonna but laughs off people’s concerns about deadlier ingredients in vaccines and other drugs.

      If you understood that the poison is in the dose you would understand why there is a lack of concern with the “deadlier ingredients in vaccines and other drugs”. It’s not the presence, it’s the dose.

      Perhaps if Hylands were regulated and monitored to the level of actual pharmaceutical companies this wouldn’t be a thing. But they’re not, they got sloppy with QA, babies very likely died because of it.

  • When my daughter took this product she almost died on my she is now 2 and has breath holding spells and they lead into seizures the doctors can still not tell me what causes them … she has to live with it for the rest of her life…

    • I have great sympathy for your daughter, you and your family. This must have been a terrible situation for you all. However, it is highly unlikely that any homeopathic medicine could have caused your daughter’s problems. The teething tablets contain two trillionths of a gram of substance. The FDA analysis found at most 53.4 billionths of a gram of substance in Hyland’s products. Neither of these amounts could possibly have any negative effects whatsoever. In fact, a child would have to ingest 12 bottles of tablets in order to develop even the most minor symptom of belladonna toxicity which is a dry mouth.

      Your doctor should be investigating other causes for her condition. The fact that a person has taken a drug and then become ill in no way assures that the drug was the causative agent. Perhaps if your doctor investigates more thoroughly he or she will be able to put a stop to her breath holding and seizures.

    • Breath holding spells are can be linked to low hemiglobin and hematocrit. My daughter had them. I am not saying your doctors don’t know this because they might but it took a couple of peds to figure it out for us. So just in case they haven’t.

    • Breath holding spells are can be linked to low hemiglobin and hematocrit. My daughter had them. I am not saying your doctors don’t know this because they might but it took a couple of peds to figure it out for us. So just in case they haven’t.

  • Korsakoff dilutions don’t enter into it. The Fluxion manufacturing method is deserving of serious criticism but also doesn’t enter into it. It is good to question the integrity of good manufacturing practices. However, historically, given the strictness of the rules and the simplicity of the protocols there have been fewer such issues by far than for any other type of medicaments. If the FDA had been doing its job they would have conducted inspection audits and the manufacturers would have readily complied.

    If there was some contamination or adulteration of the end-user product, the the homeopathic angle disappears. It then doesn’t enter into it. This all becomes like a bad batch of Greek yogurt.

    The incident evidence here deserves to be considered with respect but it is of very quality, carries little weight. Proper follow up should have been done. Details please. That this has not been done is most improper and raises the question of this all being a ‘staged’ event. I write as a licensed private investigator and science director. This stinks. All smoke, no fire.

  • For the longest time its enemies denounced homeopathy as totally ineffective, a placebo, incapable of effecting anything. Now hypocritically, critics have discovered that homeopathy is magically able to impart huge effects. But only to harm. So from being impossible homeopathy is now dangerous. But, if this stuff can do harm then it is not a reach to find it can do good. And those homeopaths have 200 years of positive clinical evidence to summon up.

    By the way do not image the few speculative notes by some pathologically hostile practitioners counts for anything. This is rotten forensics, absent method or standards. On such rubbish evidence one cannot build an entire scientific and regulatory regime.

  • ChristyRedd,

    That’s disingenuous to say the least.

    Adverse reactions to homeopathic medicines are possible if they are contaminated or adulterated for one thing. Many homeopathic medicines contain lactose. Admittedly, the amount would not bother most people with lactose intolerance. And as this article shows, contamination as a result of poor quality control is possible. I dread to think what might happen if nosodes or sarcodes were involved. Or toxins like Botulinum.

    Also, pretending that “aggravations” and the “healing crisis” are not side effects/adverse reactions is dishonest, if you assume that they are real things.

    You know as well as I do that J T Kent said –

    “If you see that a patient must go in twenty-four to forty-eight hours, and suffering, it is a delightful part of Homoeopathy to administer Euthanasia to arouse vital action suddenly and permit the patient to go.”

    Homeopaths regard Kent as almost as important a figure as Hahnemann, especially in the US. The meaning of this aphorism is very clear.

    • The meaning of Kent’s statement is that homeopathy can ease the fear some people feel when they are dying.

      It is disingenous of you to take advantage of how the English language was used in the 1800’s to imply that any homeopathic medicine can cause death.

    • That’s a very strange reading… The meaning of that aphorism is clear. If Kent had meant what you imply, he would have used very different words. Kent is clearly using the word euthanasia in the context of causing death to end suffering – rather than

      “The concept of euthanasia in the sense of alleviating the process of death goes back to the medical historian, Karl Friedrich Heinrich Marx, who drew on Bacon’s philosophical ideas. According to Marx, a doctor had a moral duty to ease the suffering of death through encouragement, support and mitigation using medication. Such an “alleviation of death” reflected the contemporary Zeitgeist, but was brought into the medical canon of responsibility for the first time by Marx. Marx also stressed the distinction between the theological care of the soul of sick people from the physical care and medical treatment by doctors.”

      In Kent’s time, there was an organised euthanasia movement in the US. The arguments were the same as used today. Attitudes towards euthanasia of US homeopaths of the time are not clear but Kent’s writings do contain mention of euthanasia.

      “What is more inhuman than to leave the suffering patient in his last moments to writhe in the agonies of dissolution, surrounded by weeping friends. The true physician will embrace the opportunity to exercise his skill at these moments. It has come to pass that I am invited frequently to stand at the bed of moribund patients, whom I never attended during their curable ills, and as many times do I thank the Grand Master for the wonderful means of allaying the pangs of the flesh, without resort to the necessity of departing from that homoeopathic law which I have so many times pronounced universal, even in the last moments–a euthanasia.”

    • Plain and simple: Homeopathic medicines are incapable of creating life threatening situations.

      “Skeptics” have claimed for years that homeopathy can’t possibly have any effects at all because it’s “just water”. In fact, “skeptics” have often stated that since homeopathy has no effects the only way it can cause harm is when someone uses it instead of “real”, science-based medicine. Now you want to spread the opposite misinformation about homeopathy by taking advantage of the FDA’s warning.

      You can’t have it both ways.

    • Plain and simple: Homeopathic medicines are incapable of creating life threatening situations.

      Would you say that withholding lifesaving treatment is, or is not, “creating a life threatening situation”?

  • I recently had an adverse effect to a homeopathic remedy. Rash, pelvic pain. The practitioner basically dismissed me. So I sent her this article. Of course adverse reactions are possible. I don’t understand why anyone would deny that. These are “medications” and should be wisely and with caution. And investigations should occur.

    • JoAnn,

      Is it possible that you are confusing homeopathy with herbal medicine or some other natural system of medicine? Adverse reactions to homeopathic medicines are NOT possible because most of them do not contain even one molecule of the original substance. It is not possible for less than a molecule of substance to create an adverse event. Large studies, replicated research, have proven that.

      This article proves absolutely nothing and will not change these facts about homeopathy.

    • Christine said:

      “Is it possible that you are confusing homeopathy with herbal medicine or some other natural system of medicine?”

      What’s natural about the way homeopathic products are manufactured? Or the ones made from microwave oven or mobile phone radiation? Or the ones made from synthetic drugs?

      “Adverse reactions to homeopathic medicines are NOT possible because most of them do not contain even one molecule of the original substance.”

      Except the ones that do – and I saw what you did there (“most of them do not contain even one molecule”).

      But then there’s things like this:

      “Q. Do homeopathic remedies have side-effects?
      A. Yes they do. It is a myth that there are no ‘side-effects’ with homeopathy.”

      http://homeopathyplus.com/q-do-homeopathic-remedies-have-side-effects/

      Then there’s homeopathic ‘aggravations’.

      “It is not possible for less than a molecule of substance to create an adverse event. Large studies, replicated research, have proven that.”

      Really? But please say what ‘less than a molecule of substance’ means.

      But if it’s not possible for a homeopathic potion to have an adverse effect, perhaps it is concomitant that
      it also cannot have a beneficial effect?

      But please provide links to these trials of which you speak that ‘prove’ your claim.

      “This article proves absolutely nothing and will not change these facts about homeopathy.”

      LOL!

    • Alan,

      When a lay person uses the term “side effect” he or she is thinking in terms of
      side effects caused by conventional drugs. Those side effects are actually diseases caused by the drug. Homeopathic medicines do not cause diseases. If you are now claiming that homeopathics can cause diseases, you are stating that they do have effects; that is, they are not “just water” as “skeptics” have claimed for so many years.

      The article you reference pertains to provings. What sometimes happens in practice is that a medicine will aggravate. As large studies show these aggravations are minor or moderate in nature, last brief periods of time and do not cause harm.

      http://homeopathyresource.wordpress.com/2009/01/05/extensive-study-concludes-homeopathic-remedies-and-treatment-are-safe/

      Read the body of the study. It references an earlier study which shows the same thing.

    • @ChristyRedd
      If the manufacturing process is poorly done, as in this case, and particularly as contamination must be almost inevitable unless the mixing vessels are replaced with each batch, what would be the effect in your view of getting a dose of the wrong homeopathic medication?

    • We don’t know that the mfg. was poorly done. It depends on their tolerances. And one of the accepted ways homeopathic attenuation may be done is by reusing the same container to do the serial dilutions by exploiting the carryover after emptying, known as Korsakoff potentization. It would be unusual to do an “X” (decimal) attenuation that way, but if the dilution is done that way, one would expect that over the course of serial dilutions, random or possibly systematic error could result in variation in final concentration that would span an order of magnitude or more.

    • We don’t know that the mfg. was poorly done.

      This is the logical conclusion of the findings.

      If it wasn’t done poorly it was done intentionally. Can you think of another option?

      While I don’t agree with the company’s choice of product I also don’t suffer from the delusional worldview that so many alt-med whackjobs subscribe to. Hylands, just like every other business in the pharmaceutical industry, wouldn’t have intentionally set out to harm their customers.

    • The option is as I explained: use of a mfg. method whose tolerances allow for the variation seen, because the product is still acceptable and safe.

    • The option is as I explained: use of a mfg. method whose tolerances allow for the variation seen, because the product is still acceptable and safe.

      That’s an assumption you made. Unless you can demonstrate that this is the case you’re doing little more than clutching at straws.

      Regardless, the dilution level at which the source material is detectable is far far less than that on the packaging (where there should be no possibility of detecting it at all.) So the thing in the bottle is not the thing advertised on the label/packaging. Also, from the principles of homeopathy it is far less powerful.

    • That’s not an assumption, that’s just an answer to the question of what the possibilities are, from the POV of someone experienced in the medical products industry and knows something of QC.

      Also, the labeling and potency of a homeopathic product does not necessarily correspond to the concentration of material in it, but to the process of dilution (called “attenuation”, or, paradoxically, “potentization”) it has gone thru. Even the word “potency” doesn’t have its usual pharmacologic meaning, for otherwise 10 times the dose of a 5X would have the same effect as a dose of a 6X.

    • The option is as I explained…

      That’s not an assumption, that’s just an answer to the question of what the possibilities are

      You seem fixated on this one despite you later add that it’s one of a range of possibilities. My comment on you making an assumption was in the context of you focusing on just one of these things.

      Regardless, if the “tolerances” are such that what ends up in the bottle does not reflect what is on the label that is still a shoddy process and/or QA.

    • Then you didn’t read what I wrote about Korsakoff attenuation: that its labeling is as to the process, not to the amount of material that results. It has undergone the process n times; doesn’t mean you can exactly calculate the amount remaining by knowing n.

    • Then you didn’t read what I wrote about Korsakoff attenuation: that its labeling is as to the process, not to the amount of material that results. It has undergone the process n times; doesn’t mean you can exactly calculate the amount remaining by knowing n.

      I read it, but it doesn’t matter.

      You’re initial point:

      We don’t know that the mfg. was poorly done.

      You have started by conceding that we don’t know something. You have then gone on to add something to one of the possible options that are available without first establishing that this is the correct option.

      You’re adding crap on possibilities.

      Until it is established to be true that the manufacturing process was or was not poorly done adding more assumptions on top of assumptions is just pointless.

      Like homeopathy.

  • Alan H – Because of the danger of aspiration or choking, it’s recommended that babies never be left alone with a bottle propped up for drinking (with no adult supervising). See this from the American Academy of Pediatrics: https://www.healthychildren.org/English/ages-stages/baby/feeding-nutrition/Pages/Practical-Bottle-Feeding-Tips.aspx While it’s not entirely clear that this is what was done here, from the description in the article it sounds like this was the case.

    • Betsy

      I have no reason to doubt that is a cause of death of some infants, but that was not something I was asking about. You claimed:

      “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.”

      It was your claim that “it’s considerably more likely” that I was asking about.

Sign up for our Biotech newsletter — The Readout

Your daily guide to what’s new in biotech.