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FDA Confirms Toxicity of Homeopathic Baby Products; Maker Refuses To Recall (arstechnica.com)
Last year in November, the Federal Trade Commission issued an enforcement policy statement that requires over-the-counter (OTC) homeopathic drugs and product makers to disclose in their advertisement and labeling that there is no evidence that homeopathic products are effective. At around the same time the FTC issued the statement, the Food and Drug Administration was investigating homeopathic teething gels and tablets, which may have been improperly diluted, thus causing serious harm to infants. The FDA investigated 10 infant deaths and more than 400 reports of seizures, fever, and vomiting and confirmed Friday that belladonna, also known as deadly nightshade, was the prime suspect. When the FDA notified the products' maker, Hyland's, the company would not agree to recall the products. Ars Technica reports: Hyland's has been defensive since the FDA first opened the investigation last September. In an October press release, the company referred to agency's warnings as a source of "confusion" and assured consumers that the products are safe and effective. Still, the company discontinued distribution in the U.S. The National Center for Homeopathy, which has ties with Hyland's, slammed the FDA, calling the agency's warnings "arbitrary and capricious." In an "action alert," the organization went on to suggest that warning was prompted by "groups interested in seeing homeopathy destroyed" and led to "fear mongering" by the media. As before, the FDA is urging parents to avoid the homeopathic teething products and toss any already purchased. The FDA does not evaluate or approve the homeopathic products, which have no proven health benefit. Belladonna is an active ingredient in those products, but is supposed to be heavily diluted. Homeopaths belief that ailments and diseases can be cured by trace amounts or "memories" of toxic substances that mimic or cause similar symptoms. Homeopathy is a pseudoscience that has been squarely debunked, offering no more than a placebo effect. In its announcement Friday, the FDA said it had found inconsistent amounts of belladonna in Hyland's products. Some of the amounts were "far exceeding" what was intended.
but from what I've heard there's been some deaths (10?). Why the hell don't we give our FDA enough power to shut this company down? They're still selling the stuff. And in packaging that makes it look like medicine.
Cutting back on bureaucracy and regulations sounds great in theory but, well, this is what it gets you.
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It is a grandfathered legality from the days before the FDA. Homeopathic "drugs" have not been through clinical trials or been shown to be efficacious. They are based on a principle that somehow if you have a substance you can dilute it until perhaps only a couple of MOLECULES in your liquid will somehow cure your problem.
The FDA should shut down this sham of a company once and for all.
See it from their point of view: Homeopathy uses the same logic as vaccines.
However, unlike vaccines, with homeopathy, the undereducated are only damaging the likelihood of diminishing the number of their own offspring. Ignoring vaccines designed to protect herd immunity hurts the rest of us, too.
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I am a father of 8, and I have plenty of anecdotal evidence that Hyland's teething tablets are effective, and I want to continue to use them for my baby. ...
Um, shouldn't your focus be on contraceptives?
sigs are for losers (except to point out that sigs are for losers)
Is that where you start out dissolving one baby per unit of inert carrier fluid, and then perform series of repeated dilutions until you are left with a substance that statistically contains no atoms of the original baby?
Does this have anything to do with the making of baby oil? I've always been afraid to know what happens inside those factories.
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As long as North America insists on persisting their "My ignorance is just as valid as your knowledge", this problem will never go away, and people will continue to die.
Quite frankly, I'm at the point now where I don't think the FDA should do anything. These people are just so god damn willfully stupid that there's absolutely nothing that can be done short of putting them in an asylum. But since we won't... let them make their choices and suffering the consequences.
The FDA is "obviously" being paid under the table by Big Pharma(tm) to keep homeopathy down because homeopathy is such a clear threat to Big Pharma profits. So basically they're damned regardless of what they do. If they try to regulate homeopathy, that would effectively give homeopathy unwarranted legitimacy. If you try to shut it down, 10s of thousands of brazenly stupid idiots will start shouting and flailing pitchforks about with the usual battlecries of... well... the kinds of stuff already mentioned in the article/summary.
I don't think this should even fall under FDA juristiction anyway. It should be treated like the criminal matter that it is. The gov't should charge these parents with child endangerment and manslaughter for knowingly giving their kids poison, because that is exactly what they did.
We read your post. You're trying to defend giving your children a toxin, Mr. Christian Anarcho-capitalist...
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There used to be this great Seattle-based comedy show called Almost Live (a sort of low-budget SNL), and they had this really hilarious skit with this tobacco company executive insisting "Smoking is completely safe. Leading chiropractors have found it in fact puts a protective lining on the lungs!"
The world's burning. Moped Jesus spotted on I50. Details at 11.
Benadryl (diphenhydramine) works similarly to belladonna. It also has the bonus of being a regulated product, properly labeled, and with a known dosage. Iirc that's 12.5 mg for children's benadryl. How much belladonna is in the hyland product? It probably doesn't say on the box, but it seems like its enough to kill the kids, sometimes.
Homeopatic meds have very highly diluted principal ingredient. Supposedly the more diluted the stronger the medicine. In this case why not just drink tap water it already contains and has interacted with every possible poison at some time. Thus it should be the most potent medicine of all !
If it has active ingredients at all, it's not homeopathy.
-jcr
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One which has been used in herbal medicine for centuries as a pain reliever, muscle relaxer, and anti-inflammatory, and to treat menstrual problems, peptic ulcer disease, histaminic reaction, and motion sickness.
Secession is the right of all sentient beings.
People have used all sorts of things for centuries, that doesn't make them less toxic. You're feeding your children poison. You should be rotting in a jail cell, Mr. Christian Anarcho-capitalist.
The world's burning. Moped Jesus spotted on I50. Details at 11.
Er... Um... huh. This is a weird thing to respond to.
I'm not going to do a super long post here, but: "the effective ingredient in them is probably the belladonna rather than the homeopathic ingredients" is wildly off the mark. The point of homeopathic medications is that the active ingredients, including the belladonna, are present in such tiny amounts that they don't do anything. You can put poison in these things because there isn't enough to matter.
This is why the FDA doesn't regulate them: because they don't do anything. This is also why over-the-counter homeopathic remedies for infants weren't removed: because they don't do anything, so they aren't dangerous. In principle you can give your baby as much as you want, because it doesn't matter.
The problem here is a manufacturing defect, some of the pills contain too much poison. When you say that you want to know "what the current consistency of the belladonna levels in the product is" what you're asking is: "What are the odds that my baby will die if I give it some of these pills?" We don't know what the answer to that is, and you may find that frustrating but... what number is low enough for you here? If the FDA comes out and says, "0.0001%" are you going to shrug and say, "That's fine."?
Interestingly, this isn't the first time that this product has been scrutinized by the FDA over this issue. Link.
You're not planning on having your kids vaccinated against communicable diseases, are you?
My kids are vaccinated.
Giving your kids a preparation containing an unknown quantity of belladonna ?
The FDA let them back on the market a few years ago when the problem with uneven levels of ingredients was supposedly fixed. So is the FDA admitting they flubbed up, here? Did Hyland's stop meeting the quality standards that got them back on the market? What has changed, exactly?
Secession is the right of all sentient beings.
..but Belladonna is intended to be one of the "homeopathic ingredients" here (along with some other nonsense). From their website:
Calcarea Phosphorica 12X HPUS: teething, dentition
Chamomilla 6X HPUS (Chamomile): for peevishness, restlesness and irritability
Coffea Cruda 6X HPUS: sleeplessness
Belladonna 6X HPUS (0.0000003% Alkaloids, calculated): redness and teething discomfort
To be clear, belladonna seems like a possible legitimate treatment (it does deaden nerves) if you got a real dose - but probably isn't effective at the intended concentration (nor is it probably a great idea in any case... I mean, opium would probably deal with teething pain too, but your pharmacist is hardly going to give it to your for teething). So if the gel is ever doing anything (via the actual effects of belladonna, rather than the backwards magic effect of removing all of the belladonna), that itself is evidence that they've screwed up their process and are getting more in than they meant to. Which isn't what you want to hear when the ingredient in question is straight-up-good-way-to-murder-someone poison.
Let's not stir that bag of worms...
Make sure you bleed them regularly, to keep their humors in balance and drain off toxic blood.
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Or perhaps they (Hyland) did something else to warrant FDA's attention? Just to say - I remember a perfectly effective topical antiseptic called mercurochrome, which ended up being removed from the market here in the US because of the mercury present even though there was no clinical evidence that its use could cause mercury toxicity. With that said to support your position, in this instance I suspect that ten dead babies was probably evidence enough that Hyland's belladonna-containing homeopathic remedy is dangerous.
You're in the position of claiming that a demonstrably dangerous remedy isn't dangerous because you've never personally had a bad experience with it. Demonstrably dangerous. There's a body-count associated with this preparation. Not just hand-wringing because it contains mercury or belladonna. Dead babies.
Hey, I finally found an appropriate outlet for all those old 'dead-baby' jokes! Cool!
So you just found out that the active ingredients in the product you are buying is not what the producer claims
No, I have known for two decades that homeopathy doesn't work, so I knew all along it wasn't the homeopathic ingredients they list that was doing the work.
Secession is the right of all sentient beings.
Reading the way you wrote (as opposed to what you wrote), you do not seem to be a drooling idiot, so you must be misinformed / uninformed about the definition of homeopathy. In other words, a reasonably intelligent person who got scammed. I've seen intelligent people confuse "homeopathic" with "holistic", that can certainly happen.
Here's the theory of homeopathy, how proponents claim it works:
For any ailment, you find something that will *cause* that ailment (ie a poison).
You then place a drop of the poison in a bucket of water and mix it up.
Then you take a drop from that bucket and put it into another bucket of water.
Do this several hundred times. (This is why it's labeled "300X", it's been diluted 300 times).
In the end, they'll be no poison left the last bucket, but because you had put poison in the other bucket, the water in the last bucket will do the opposite of what the poison does.
That is of course, utterly and completely ridiculous. If done correctly, there will be zero molecules of the poison in the bucket - it's 100% water. You just paid $8.99 for WATER. If it's done incorrectly, as Hyland's did, you end up with poison in the product.
Please double check to confirm my explanation is 100% correct.
It seems some people confuse "homeopathic" with "holistic". Those are of course two very different things.
A short explanation of homeopathy for those unfamiliar:
For any ailment, you find something that will *cause* that ailment (ie a poison).
You then place a drop of the poison in a bucket of water and mix it up.
Then you take a drop from that bucket and put it into another bucket of water.
Do this several hundred times. (This is why it's labeled "300X", it's been diluted 300 times).
In the end, they'll be no poison left the last bucket, but because you had put poison in the other bucket, the water in the last bucket will do the opposite of what the poison does.
That is of course, utterly and completely ridiculous. If done correctly, there will be zero molecules of the poison in the bucket - it's 100% water. You just paid $8.99 for WATER. If it's done incorrectly, as Hyland's did, you end up with poison in the product.
My problem is that tylenol is demonstrably dangerous if you don't use it as directed, and the FDA is still happy to pull certain tylenol products off of the market simply because some people are too stupid to use it as directed. So I would like the FDA to clarify if these deaths are happening from people who followed the directions, or if they are happening when people give tons of it to their kids like rats in a saccharine study.
Secession is the right of all sentient beings.
Superficially the idea may appear the same. The idea of vaccines, however, is to introduce a weakened form of the disease's cause, before the disease is contracted (or at least before it spreads), so the immune system can prepare for it. (Modern) homeopathy involves introducing (water which was indirectly in contact with) a substance which produces the same symptoms, after the disease is contracted. Notable differences are:
These are significant differences.
Also, I've never heard of a homeopath suggesting a similarity between homeopathy and immunisation. (I'd love to see this though, if anyone has a link to such.)
On one hand, I truly believe that homeopathy doesn't work. Period.
But I also support the use of the placebo effect to address minor problems. All drugs carry a risk associated with them, and if we can cure your mild headache with a pill that does nothing, that beats curing a mild headache with a molecule that may have side-effects.
The problem is that placebos only work if you believe in them. And they work better if they are expensive. And to have people make money out of ignorance makes me cringe.
So I choose to support ending the whole homeopathy deal. But I would be looking into other, ethically reasonable ways to make use of that effect by modern medicine.
it's here in case you missed it. I recommend comparing it to say, a package of neosporin. Just glance at them. Pick out the outlines. They looks about the same don't they?
/. and read the stories on Homeopathy.
Homeopath companies know what they're pushing is junk science. So they dress it up to look like real medicine. I've tried plenty of actual medicines that people swear by but that do nothing for me. I don't keep trying them, but still. There's a lot of OTC stuff out there. Now, as a nerd I'm intensely cynical (comes from the years of bullying). Take somebody who hasn't been shit on their whole life and it's not too hard to see them making the mistake. Especially if they don't frequent
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All medicines are poisons. The difference is dosage. When the FDA yanks normal cold products for infants because parents can't get the dosage right, it's a legitimate discussion.
Socialism: a lie told by totalitarians and believed by fools.
How about exposing babies to peanuts so they don't develop life-threatening allergies later on?
The packaging for the product described in the OP looks no different from five similar and safe products that are on the shelf at your local drugstore. The word "homeopathic" is in small type compared to other marketing words - which are the same words used on much safer products - and many people have no idea what "homeopathic" means in any case.
So yeah, no. This is a clear case of misleading packaging and marketing; whether it is a criminal case remains to be seen.
Done! http://www.health.harvard.edu/...
"In 2015, a study showed that giving peanut products to babies could help prevent peanut allergy. This was exciting news, given that 1-2% of children suffer from peanut allergy, an allergy that can not only be life-threatening but last a lifetime, unlike other food allergies that often improve as children get older. "
In the forest of anti-FDA and/or pro-homeopathic comments above, I was curious, so as far as I can determine, this is the FDA timeline for this...
September 30, 2016
The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.
Reference to adverse event reports here. Multitudes of reports reference events of seizures by infants.
January 27, 2017
Laboratory Analysis of Homeopathic Teething Tablets
FDA has completed testing of homeopathic teething tablets labeled as containing belladonna and other ingredients and marketed by CVS and Hyland’s Inc. Our testing found that the belladonna alkaloids (atropine and scopolamine) content and coffea cruda (caffeine) content is not uniform among the manufactured tablets. FDA analysis found the levels of atropine and scopolamine in some of the CVS tablets and the levels of scopolamine in some of the Hyland’s tablets far exceeded the amount stated on the products’ labels.
This is despite Standard Homeopathic Corporation (the manufacturer of Hyland brand Teething Tablets) insistent claims in voluntary reports that "Manufacture and processing occurred within established procedures to ensure product quality."
So you are the administrator of the FDA and are sitting on the pile of adverse event reports and have this completed laboratory testing report.... What would you do?
According to the report the product had very inconsistent amounts of the deadly nightshade. Most tablets had amounts that couldn't even be measured which is the safe standard, others had over a thousand nanograms of the belladonna atropine (one of it's alkaloids) and several hundreds of nanograms of the scopolamine.
Given that for adults the "prescribed" levels are like 0.05g of the leaves (which only contain ~1% of the atropine by weight) for a psychoactive effect, you could consider that these are potentially lethal to infants.
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Good occasion to watch Tim Minchin's "Storm" again, about alternative medicine and such. (Skip the first minute)
Best quote from that video: By definition, alternative medicine has either not been proved to work, or been proved not to work. Do you know what they call alternative medicine that's been proved to work?...
Medicine.
Um, shouldn't your focus be on contraceptives?
He's feeding deadly nightshade tablets to his kids. The problem will sort itself out.
SJW n. One who posts facts.
Just because you can't read doesn't mean the FDA isn't telling.
They released their numbers, they aren't very useful since they varied widely within the same bottle and hence tell you next to nothing about any individual tablet.