Both of these drugs are used in varying amounts in real medicine because they are potent anticholinergics. Indeed atropine is the typical drug of this class, and the WHO lists it as one of the few basic necessary medicines needed for an adequate healthcare system. Millions of people are prescribed atropine to control bladder or gastrointestinal spasms; we use it in mega high concentrations in resuscitation efforts because it makes your heart beat faster. So you can see they are serious drugs - when purified and used in concentrations more than a thousand times that used in Hyland's Teething Tablets. It is very possible to give yourself belladonna poisoning, but I would imagine most children would have to eat at least a bottle or several bottles to achieve even the milder adverse effects.
Ironically the dose is low enough that if Hyland's was advertising that their product contained atropine, the FDA and normal medical practitioners would probably be claiming that they're nothing more than sugar pills.
Despite the well-established nature of atropine, and the fact that the "homeopathic" dose is something like a thousand times less than any medicinal use, this is how the FDA chose to inform the public about the drug:
Belladonna is commonly known as Deadly Nightshade. It is a plant whose leaves and berries are extremely toxic. Belladonna has been used as both a poison and a medicine throughout history.Acting more like it's a medieval poison than a modern medicine.
The FDA isn't saying what symptoms they received reports of, or how many occurrences. On the other hand, you can readily find dozens of real-parent reviews of Hyland's Teething Tablets, or look over the Facebook fan page for more accolades. No reports of adverse effects are easily found online; let me know if you come across any.
It's just dumb. Dumb, dumb, dumb. This product is so benign it's not even funny. I'm sure this is chiefly based on the fact that belladonna, used as a plant-based ingredient, contains recognized drugs, but is not a purified or easily measurable form of the molecular drug compounds. The FDA would probably happily recognize and study Hyland's Teething Tablets if they were purified prescription drugs manufactured by Big Pharma. But they're not, nor do they need to be, and Hyland's probably doesn't have the resources to begin processing like a big pharmaceutical company. So the FDA will just wear them away.
Ironically the FDA action and recall led to the product selling out on Amazon.com. My wife knows someone who just ran around town and purchased 25 bottles.
Crap! I love that stuff. I think that's the company that also sells homeopathic ear drops for ear ache, and eye drops to aid with pink eye. (I've used the latter, it didn't cure it but it did aid extremely well with the inflammation)
ReplyDeleteI was able to find only 1 bottle :(
ReplyDeleteAnd yet children's tylenol remains on the market, flying off the shelves.
ReplyDeleteYikes.
ReplyDeleteI used it will all my bio kids.
I could not get permission to use it with my foster kids. That was frustrating.
What is this world coming to?
I ran to my local store as soon as I heard and purchased 4 bottles and told my friends to do the same!
ReplyDeleteNurse XY, yeah, I was thinking about how long it took the FDA to recommend against children's cough medications! Like years after there was tons of evidence it was bad for kids.
ReplyDeleteThank goodness we are past teething! That was my go to of choice and it was a lifesaver...this is the most absurd thing I have heard!
ReplyDeletedoes anyone know if this applies to the teething gel as well?
ReplyDeleteI've heard the Hyland's teething gel is not affected by this recall. It contains belladonna as well, but at 6X instead of 3X. I don't know homeopathic dosing - does that mean it's less?
ReplyDeleteRidiculous. If it hadn't been for teething tablets, I would have orphaned my former preemie with sensory problems when he was teething. Lord knows he has received dozens of big pharma products in the NICU and beyond (most of them off-label) that were a thousand times more dangerous to him than a gallon of Hylands tablets.
ReplyDeleteThe sad part about the FDA announcement is that there are probably lots of sheep in parents clothing shitting bricks about poisoning their children. Especially at this time of the year, I despise being manipulated by half-truth disinformation.
Homeopathy? Yeah... that speaks for itself, and what it has to say is b.s.
ReplyDeleteMore here, if you're gag reflax can handle homeopathy madness: http://theness.com/neurologicablog/?p=2453
M'y gag reflex can't handle bad grammar.
ReplyDeleteThanks for the link, Coffee Run. It led me to an illuminating study of homeopathy as a discipline. Before this I was only vaguely aware of homeopathy as a "produce the symptom to cure the disease" (i.e. like cures like) theory, but figured that this was old-fashioned and nowadays homeopathy only singified, well, "natural medicine."
ReplyDeleteI had no idea about the serial dilutions and whatnot which really do sound like snake oil.
However, given that these teething tablets (and other homeopathic remedies I've seen) DO contain "real medicine", it seems that they don't equal snake oil. Indeed, that post you link makes the seemingly contradictory point that homeopathy is a useless fraud AND that homepathic remedies are dangerous because they're unapproved medications.
I don't really have a bone to pick in this fight; not having known about homeopathy before, I'm not running to its defense. I will defend what has seemed to work for me and my kids in the past. But I'll grant that these tablets don't seem to be "real" homeopathy by definition, if they contain medicines, and therefore might need to be regulated like OTC herbals - which isn't very much, though, so that isn't going to make people like that article author happy.
THANK YOU for this. I am on both sides of this as a hippie mama and nursing student trying to explain that teething tablets are NOT full of deadly nightshade. My daughter ate a whole bottle of them once when she had all of her teeth, and knowing what I know of homeopathy I didn't even call poison control. However...I'm also not devastated that they're going bye bye...they never did much for my teething babies and that's one area where I love me some Western Motrin relief.
ReplyDeleteFrom what I have read on the recall, the issue was not that the Teething Tabs contain homeopathic dilutions of belladonna, but that a failure in Hyland's quality control process resulted in some tabs containing LARGE doses of (presumably undiluted) belladonna; some children were hospitalized as a result. Inconsistent amounts of a potentially deadly substance was the issue, not that the tabs contained the proper homeopathic dilution.
ReplyDeleteDuring the 19th century, many households had liquid suspensions of belladonna available, as it was a commonly prescribed remedy. Many women, however, overdosed to commit suicide with it.
As with all naturals (and I could write a book on the principles of homeopathy as another topic), respect them as you would a pharmaceutical. Know their properties. Know drug interactions. Know contraindications. They absolutely have their place in treatment. But natural does not always equal safe for everyone or every situation.
Unfortunately quality control issues plague supplement manufacturers and have brought increased FDA attacks on the industry. Some supplements are manufactured in China, with minimal if any QC, and contain traces of harmful look-alike herbals and also lead. Other brands of supplements, such as elderberry, contain the leaf and bark (which are toxic!) in addition to the berry, which has fabulous anti-viral and anti-influenza properties. Caveat emptor...and most people do not research enough to know that often, which part of the plant is used matters extremely much, as varying parts of the plant often have different properties. Then again, most health food store employees don't know this, either.
Dianne - what you're saying is essentially the same thing the FDA is claiming. Do you have any more information or links about it? I'm curious what happened to the kids in question. I could theoretically see some kids going to the ED with nausea and vomiting, and the ER docs filing adverse drug reports - but who knows. Maybe there were serious adverse effects.
ReplyDeleteAs I said above, if they're using whole-plant belladonna, then they probably don't meet the strict "quality control" measures that the FDA requires of, say, purified atropine. Likewise red yeast rice would not meet the FDA's quality control criteria to be marketed as a statin, even though it has difficult-to-control amounts of lovastatin. I don't know if using belladonna in your OTC drug means that you have "poor quality control"; it might just mean you're using a smashed and dried plant extract, instead of pharmaceutical-grade molecularly purified extracts.
I'm curious why the FDA seems so bad and clumsy at regulating these kinds of meds and supplements.
It is wonderful to have homeopathic alternatives on the market, but I'm tired of seeing the FDA painted as the villain here. This was a voluntary recall which means Hylands saw a problem and conducted the recall, yes they had the assistance of the FDA as would any company in this situation. But in all honesty the FDA is powerless. They can only advise a company to conduct a recall and if you knew of all the times companies ignored the request you would not want to ingest anything ever purchased from a store.
ReplyDeleteI don't see how a voluntary recall can be seen as anything but coercion - the FDA issues a public announcement recommending a recall and giving some nebulous information implying the product is poison. Hylands really has no choice but to comply, refusing to paints them as irresponsible since an 'official authority' has already branded their product as toxic. If Hylands had made the first move and recalled their products before the FDA publishing their request the above comments would make sense but you have it backwards there.
ReplyDeleteHyland's FAQ regarding the situation can be found here: http://www.hylandsteething.com/recall/teething-tablet-recall-faq.html ; their belladonna FAQ sheet here http://www.hylandsteething.com/recall/belladonna-safety-info.html .
ReplyDeleteTheir position is that 1) FDA inspection of their manufacturing facilities highlighted QC problems ("opportunities for improvement") with uniformity in dosage; 2) Adverse events (fever, dry mouth, drowsiness) have been reported as linked to the Teething tabs but that the link is not conclusive; 3) Each teething tablet contains 0.0002 mg belladonna alkaloids from the whole plant; 4) a 10 lb child would have to ingest 6 bottles of 125 Teething Tablets to exhibit belladonna-induced side effects; and 5) anticholinergic symptoms associated with belladonna overdose can have multiple other causes in children.
The FDA's initial page (link no longer functioning) stated "FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps." It went on to say that FDA laboratory testing found the tabs to contain "inconsistent amounts of belladonna".
The FDA's *current* page on the subject, found here http://www.fda.gov/Safety/Recalls/ucm230769.htm, is just a reprint of Hyland's press release page on the issue. Not sure why the change...perhaps because Hyland's voluntarily recalled the product they eased pressure on teh company and retreated to less alarmist language??
The FDA has limited regulatory authority over herbals and homeopathics; it regulates these as foods and not as medications. It would *like* very much to regulate supplements as medications; the FDA gets a lot of support (money, political clout) from Big Pharmacy, and Big Pharmacy sees the burgeoning supplement industry as a threat. If the FDA were able to regulate supplements as medications rather than as foods, we would likely see most of them vanish from our shelves while they get bogged down in the drug approval process. Many of them would never be seen again.
Thus, the uneasy coexistence of the FDA and the supplement industry.
For most American consumers, its about freedom of choice. Supplements are perceived as having fewer side effects than prescription drugs, and working more harmoniously with the body than many prescription drugs. They are also more affordable by those who do not have health insurance, or who have limited health insurance, than are prescription drugs.
I write from the perspective of having been an herbalist for 17 years and an aromatherapist for 15. I am also a registered nurse. I believe herbals, aromatherapy, homeopathics all have a valuable place in the healing arsenal. I believe they should be available to the public. However we have some problems.
ReplyDeleteProblem #1: Poor quality control by supplement manufacturers. By this, I'm not referring to a supplement manufacturer being unable to turn smashed plant matter into a high-grade, molecularly pure pharmaceutical extract. What I mean is, that potency is not standardized in most supplements. That 100 mg capsule of Hawthorn berry (which acts like a Beta blocker) could have a widely variable amount of active constituent. We would take it pretty seriously if a patient took 5 mg of a Beta blocker one day and 75 mg of the same drug the next day. This is, in effect, what happens to many people taking natural supplements when they purchase supplements that are not standardized for potency.
Problem #2: Many herbals are not standardized for the plant components included, or the ratio of plant components (e.g. leaf:berry:root) included. Further, some contain look-alike but harmful plants, or are processed in ways and places that allow traces of lead or other substances into the capsule (often the case with Chinese herbals, unfortunately).
This can result in the consumer ingesting a product that is anywhere from ineffective to effective to toxic to deadly.
In some plants, different parts (e.g. leaf, root) are used for different purposes. You might be getting the wrong part and unintended effects.
In other plants, some components are medicinal while others are toxic, e.g. elderberry. The berry has great antiviral properties and has been shown in double-blind trials to be effective against influenza strains. The leaf and stem are toxic.
Problem #3: Unawareness of how the supplement works in the body, dangers of overdose, and ignorance of drug-herb or drug-supplement interactions.
Most consumers, and most retailers, don't do the research to be able to safely and wisely consume or recommend trustworthily prepared supplements.
All the reasons listed above create a great set of lobbying points for the FDA to "protect" the public from "snake oil" supplements. Many reputable supplement manufacturers have instigated their own stringent quality control and independently confirmed standardization measures, as they should.
I've never been one for giving a government regulatory agency more power. Bigger, more intrusive government is never the answer. I don't want to see supplements regulated as pharmaceuticals, but supplements do need to be standardized for plant components and for potency. This is not entirely difficult to do.
We also need a new generation of healers proficient in both modalities
Thanks for this decision of FDA I like it o much keep posting and updating the blog on regular basis. I like it so much. keep posting and updating the blog.
ReplyDeleteVery cute blog i like your way of writing.
Smith ALan
When my son teethed he loved these by the end he would bring them to me when his mouth hurt. We he was around 6 months I gave him some and put him down for his evening nap ill admit he may have had 4 or 5 through out the day as he got fussy he went to sleep as usual but I heard a strange ticking noise after about 30,mins and went in to find my son having a seizure. When I picked him up he was cool to the touch but developed a fever in route to the ER so it was declared a febrile seizure tho he hadnt had the fever to begin with . A few months later I had almost the exact same incident my son had test ran and many visits to neurologists only to find he's normal and write them off as febrile. Shortly after the second episode he had no need for the teething tablets and they hit the cabnet never to be thought about again. Since then my son has had numerous fevers once with a spike reaching 103.1 with no seizures . I do not believe it takes bottles to harm a child. That's what they say to calm the masses and hope that these cases get wrote off as something else like my son
ReplyDeleteso, why do you think the tablets help teething? can it be that belladonna is having an effect at the inconsistent doses in the hylands tablets? Why is your baby happy when he sees them? Oh, the tablets are effective because there is an opiate in them. The same family as heroin. FDA does not have money or mandate to regulate this stuff, I think it is because this is a product for babies that the people there became particularly concerned. As they should.
ReplyDeleteConcentration Pills are widely using drug which helps to increase your focus by work on brain chemicals.How ever it may leads some side effects, so get a proper advice form the doctors to buy these Concentration Pills.
ReplyDelete