*RECALL* Hylands teething tablets

Charlie - posted on 10/24/2010 ( 28 moms have responded )

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FDA NEWS RELEASE
For Immediate Release: Oct. 23, 2010
Media Inquiries: Dick Thompson, 301-796-7566, dick.thompson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Issues Consumer Safety Alert
Hyland’s Teething Tablets may pose a risk to children

The U.S. Food and Drug Administration today is warning consumers that Hyland’s Teething Tablets may pose a risk to children. The FDA recommends that consumers not use this product and dispose of any in their possession. The manufacturer is issuing a recall of this product.

Hyland's Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. In addition, the 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.

The FDA advises consumers to consult their health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hyland’s Teething Tablets.

Hyland’s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets. The FDA has not evaluated Hyland’s Teething Tablets for safety or efficacy, and is not aware of any proven clinical benefit offered by the product.

An ongoing inspection at the manufacturer also indicates substandard control of the manufacturing operation. After consultation with the FDA today, the manufacturer of the product, Standard Homeopathic Company agreed to voluntarily recall Hyland’s Teething Tablets from the market.

FDA urges both health care professionals and consumers to report side effects from use of Hyland’s Teething Tablets to the FDA’s MedWatch Adverse Event Reporting program either:


* Complete and submit the report online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


For more information:


* Consumer Update: Hyland’s Teething Tablets: Questions and Answers
* Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland’s Teething Tablets to Address Manufacturing Process
* Medwatch: Hyland’s Teething Tablets
* See the FDA website for how to dispose of unused medicines

MOST HELPFUL POSTS

[deleted account]

I hope these are still on the market for our next child. What the FDA are doing is putting fear into people about homeopathic products because they can't make any money off of it. Notice that they haven't actually recalled it, just put a warning out about it. They don't have any reason that could warrant a recall so they do the next best thing and turn everyone away from wanting to use them.
Typically conventional medicine (FDA approved pharmaceutical products) contain 0.2 - 5mg of Belladonna alkaloids in their anti-spasmodic medications roughly 1000-25,000 times the amount in the Hyland's teething products. So...... your child would have to ingest more than 6 large bottles to even match this quantity. You might as well take all the bottles of Tylenol and teething gel out of your house in case your child ingests 6 of those bottles too.
So, if these worked, you should have complete confidence that the level of Belladonna is at a VERY safe level for your infant and like all medicinal products, keep them well out of reach from inquisitive hands.
Happy homeopathic mothering! :)
(Check out the book Smart medicine for a Healthier Child by Janet Zand. A great tool to have on hand for conventional and alternative remedies)

Krista - posted on 10/25/2010

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Just as an FYI, if you're in Canada, there's an alternative. Camillia teething drops by Boiron is regulated through Health Canada, so the quantity of ingredients per dosage unit has to be consistent in order for it to be eligible for registration. It has a dilution of belladonna in it, like the Hyland's tablets do. Just to make you feel a bit better, Holly, it's heavily, heavily, heavily diluted.

Here is a great article that explains homeopathic dilutions and how they work:
http://www.webworldarticles.com/e/a/titl...

Amy - posted on 11/11/2010

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The wording of the recall is actually very interesting. It says that the product "may" pose a risk to children...not that it has. It also says that there were reports of symptoms consistent with belladonna poisoning...not that it WAS belladonna poisoning. It also says that there were inconsistent amounts of belladonna in the tablets...not that the amounts were too high in any of the lots. It's interesting that the FDA is just releasing something to cause fear. There's no actual substance to the warning.



I did a great deal of research when this recall first came out, and discovered that a 10lb baby would need to take 10 bottles of 100 tablets in order to have the slightest possible chance of having belladonna poisoning. This means that for our kids, which are probably approaching 20 lbs or more, they would need to eat 20 bottles of 100 pills...2000 tablets for there to be even a chance of reaching a high level of belladonna.



In every product on the market, there are trace amounts of things that would be poisonous in large doses. Take a look at energy drinks, for example. They contain many ingredients, namely guarana, taurine, caffeine, Cyanocobalamin, citric acid and ginseng. Even though these are basically harmless when taken in low dosages, studies have shown that these ingredients can do major damage to people who don’t know how to spell moderation. So if you drink 20 energy drinks at a time, it would be very, very dangerous...but you don't see the FDA recalling those.



I am not a conspiracy theorist, but it's interesting that government agencies, such as the FDA, that are all linked together, along with the multi-billion dollar medical industry, would recall something that could put a dent in their profits. Homeopathy (or even just natural remedies) is much, much cheaper than the medical treatments for illnesses. One personal example is that my son (2 1/2) has chronic Urinary Tract Infections. We've seen pediatric urologists, and through lots of testing, they cannot seem to figure out why he gets them. They decided a long-term, low-dose antibiotic was the best way to keep them from coming back until he grows out of it. I got the medication, paid my $10 co-pay, and even though I was skeptical about long-term antibiotics, they assured me it was bladder-specific and wouldn't mask any other infections elsewhere in his body. After a month, though, we lost our health insurance because the premiums sky-rocketed, and we just couldn't afford it. When I went to refill his medicine, as a self-pay customer, I was stunned to discover that the medication is $400 for a bottle that lasts for one month. Needless to say, we just couldn't afford it, so I started researching alternative methods. I discovered that cranberry extract taken in high doses has been shown to be just as effective as low-dose antibiotics in preventing UTIs. I just ordered a month's supply of cranberry extract...$4.20. We have to recognize the push for modern methods of treatment, and we have to recognize that this is largely for monetary purposes.



As Hyland's grows in popularity (and profit), I think we can expect to see the government clamping down on them and instilling fear in the American public. They use vague, but ominous, wording to persuade the public to turn from the natural route to modern medicine. It is no surprise that the FDA went after what is most likely Hyland's highest-selling product.



I think that, as with anything, we need to make informed decisions, especially regarding our children.

Charlie - posted on 11/05/2010

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I use homeopathic remedies when i can however if homeopathic companies want to be taken seriously they need to abide by the same regulations and standards as any other company , the fact is the amounts were found to be inconsistent as with anything up for sale as a medicinal product it needs to be strictly regulated so all ingredients are used at the same level with the same consistency .

Robin - posted on 11/04/2010

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People...do some independent research on homeopathics. It is so dilute, and if it were a real risk, don't you think hylands would have been out of business long ago? It a wonderful product and the recall is voluntary by hylands to get the FDA to shut up...it's not even required

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Bernadette - posted on 11/27/2010

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when I went to get more from the chemist the other day, the pharmacist told me they had been recalled. When I asked why, he explained that it was due to inconsistencies in the manufacturing process and NOT because there was any danger. My daughter has not shown any side effects of any kind, and is teething badly at the moment so I am continuing to use the ones I already had at home. She only has 8 teeth left to come through, so won't be needing them for an extended period, only when they are actually bothering her.

[deleted account]

actually, i WAS comparing a poison to a poison - sewage to refined white sugar. at least people would never willingly feed their kids sewage (none that i know of, anyway?!). but white sugar - which is linked to cancer, diabetes, atherosclerosis, kidney disease and obesity - is willingly given to children all the time. so smarties, being the number one 'bribe' food in north america, are not considered any danger by millions of parents (so untue!!). yet people are gonna get their knickers in a twist because of a nearly undetectable amount of belladonna in hylands teething tabs??! i won't be using smarties - or sewage - to address teething pain, EVER. the comparison is illogical. however, the smarties are more than likely going to be the cause of teething pain in the future! and as far as pharmaceutical companies 'regulating' the amounts in each tablet...wake up! look at recent recalls because of serious adverse side effects due to the manipulation of clinical trials and the pushing through of certain 'popular' drugs. i trust the homeopaths and the individuals who are not profit driven over big pharma. do you know anyone who has ulcerative colitis? or parkinsons disease? then you know people who are ingesting medication derived from belladonna alkaloids. big pharma uses the same ingredients (usually synthetic derivatives) as natural or homeopathic remedies. they just make a hell of a lot more money doing it!

Amanda - posted on 11/05/2010

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My son used Hyland's Teething Tablets, and in the beginning they helped a lot. Once they stopped helping, I stopped using them. These recalls are often scare tactics and too many people are susceptible and live in fear-look at 9/11. Anyway, I did not worry about the Tylenol recall either when I found out that it was just "too much pain killer"; I just gave my son a smaller does. You are right, I didn't know exactly how much to reduce it, but it worked for us. You have to trust your gut MORE than you trust a GOVERNMENT agency. However, do what works for you. Thanks for the information. I like to be aware of it all.

Iridescent - posted on 11/05/2010

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I compared a poison to a poison. Same amounts in both scenarios. Shouldn't be any problem at all. If you want to compare them with Smarties, you're welcome to do so, and you're more then welcome to use them to address teething pain as well, although I won't do that either.

[deleted account]

instead of comparing homeopathic remedies with sewage (?)..compare them to smarties,which is much fairer. white refined sugar. do you know how dangerous this is to children? yet parents are giving their children this 'poison' everyday. why are consumers so susceptible to hype and scaremongering on the part of an agency that does not genuinely enforce 'health' - but polices commercial trading. i've got hylands and i'm gonna use them. i have no FEAR that they will damage my children whatsoever.

Teresa - posted on 11/04/2010

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I called my son's sitter and told her. She has other babies there as well and I also told her that if there are any in his bag to throw them away. I am so tired of checking lot numbers!! Tylenol, motrin, fisher price junk...I mean really!!! They were the only thing that worked for my son's teething as well and he only has five with a mouth to go so ugh!!

Stephanie - posted on 11/03/2010

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There is no danger in the amount of belladonna used in this product and I am very angered that the FDA is using these scare tactics as there is no one properly educated on the use of Homeopathics employed with the FDA! I have used Belladonna at 30ch on my son when he was 3-5 mnths for a variety of reasons and he has responded outstandingly without neary a side effect! But then I have studied homeopathics and know that they don't pose a risk unlike most actual drugs out there!

Lorraine - posted on 11/03/2010

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I used them with my son, with the recommended dosage and recommend them for other mothers. I gave him tylenol once or twice while he was teething in the recommended dosage when he was miserable. And he is just fine now at 7 years old. They took effect quickly and allowed him to relax. If used incorrectly just about everything can be hazardous, use common sense when dispensing and storing any product (medicine or candy ;>)

Jennifer - posted on 11/03/2010

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I have some of these.. but I rarely use them and only give the recommended amount, and I keep them out of reach.I've had the same bottle since my daughter was 3 months old. She is 10 months and it is still more than 3/4 full. I also used them with my other 3 kids and have never had a bad reaction. I think as long as you are careful and not giving them to your children like candy then they should be fine.

Robin - posted on 11/02/2010

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I think a child proof lid is needed, my kids have gotten into them before, but all three of mine have used these with great results, I think the FDA is trying a scare tactic, and hylands did a voluntary recall to avoid even worse press caused by the FDA. Homeopathic medicines use all kinds of stuff that is considered poisonous (rattlesnake venom for headaches for example). It's all about the minute doses that make it safe for use. Yes, a child here and there may react from an ingredient, but it's the same with any other medication, and even ones that can do major damage (black boxed by the FDA) are still prescribed daily like cipro.

Kimi - posted on 11/02/2010

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I hope the company can get this fixed and add a child proofed lid. These tablets are great.

Charlie - posted on 10/31/2010

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Whether drugs are natural or synthetic the fact is they are still drugs with potential dangers .

Merry - posted on 10/30/2010

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Crap, my son had a few a while back, no more the two a day but still. I'm pissed, I mean everyone told me to buy these as they are so natural and safe and risk free and blah blah blah and now it's the opposite! This is ridiculous you can't give your kids anything these days, breast milk is like the only safe thing I can find and that doesn't do as much good as they grow up. I wish he could just stay young forever and safe on just my milk but whatever that's the risks of living I guess.

Amanda - posted on 10/27/2010

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I didn't hear of this recall....until I got on the boards here. Great info. Thanks!!!!

S - posted on 10/25/2010

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Just talked to a representative if you choose a cash refund they say they will reimburse you for the cost of shipping the product back to them.

Iridescent - posted on 10/25/2010

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According to the homeopathic dilutions theory, you can put 1 drop of x into a vial with 9 drops of water. Shake it, take 1 drop of that and put it in a new vial with 9 more of water, etc. And after 23 times there is none of x in the vial. So, since nobody wastes things, the original vial went on to make 10 vials, then 100, down the line 23 times. This is the exact same method Hyland's said they use (Homeopathic Dilution). Everybody is capable of understanding if you never remove the original product (x) from the water itself, it remains IN it. So no matter how many vials it is divided between, it is STILL there. It's just bunk to state otherwise; some may have none, but others contain it. Pretend it's sewage, and you did the same. Would you drink it? Sewage is still in it. How is that any different than a known poison (Belladonna)?

Iridescent - posted on 10/25/2010

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Hyland's says essentially the same thing; it's so diluted that there is no belladonna actually in it, so can't cause problems. Yet look at where we are... http://www.hylands.com/news/teethinginfo... - Hyland's own website stating that your child would have to eat "multiple bottles" to have any adverse reaction. WRONG.

[deleted account]

I saw that ingredient in the tablets when I was first looking at them and immediately put the bottle back on the shelf. This is a dangerous ingredient and I was not ever going to give my kids anything with it. I'm glad the FDA is being strict on this!

Jen - posted on 10/25/2010

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Wow! I used to use these all the time. Scary. My kids are 10 and 6 now. These have been around for quite some time. =(

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