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MeganMylo
LIF Adult
Member since 2/09 1128 total posts
Name:
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FDA Issues Consumer Safety Alert: Hylands Teething Tablets
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
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Posted 10/24/10 1:17 PM  |
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Long Island Weddings
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LIMOMx2
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Member since 5/05 24989 total posts
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Ok so this ingredient is only harmful if overdosed on. Isn't that the case with any medicine? 
It worked awesome for DD.
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| Posted 10/24/10 1:19 PM |
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MeganMylo
LIF Adult
Member since 2/09 1128 total posts
Name:
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Posted by MeganMylo
FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna.
An ongoing inspection at the manufacturer also indicates substandard control of the manufacturing operation.
I think those are the problems.
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| Posted 10/24/10 1:22 PM |
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wingsofsong
My 3 little loves <3<3<3
Member since 1/09 7395 total posts
Name:
Maureen
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Posted by 5ofClubs
Ok so this ingredient is only harmful if overdosed on. Isn't that the case with any medicine?
It worked awesome for DD.
I think the issue is that the amount of belladonna in Hyland's was inconsistent, so you never now how much they are getting. That's the case with any drug not approved by the FDA. I know a lot of people have used these and love them, but I try to stay away from anything not FDA regulated for reasons like this. 
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| Posted 10/24/10 2:04 PM |
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cjik
Welcome 2010!
Member since 2/06 8879 total posts
Name:
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Posted by wingsofsong
Posted by 5ofClubs
Ok so this ingredient is only harmful if overdosed on. Isn't that the case with any medicine?
It worked awesome for DD.
I think the issue is that the amount of belladonna in Hyland's was inconsistent, so you never now how much they are getting. That's the case with any drug not approved by the FDA. I know a lot of people have used these and love them, but I try to stay away from anything not FDA regulated for reasons like this.
Same here. When I read there was belladonna in them, I put them back on the shelf. So many parents raved about them, but I don't trust this frankly (esp. if the dose isn't regulated).
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| Posted 10/24/10 4:45 PM |
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Goobster
:)
Member since 5/07 27557 total posts
Name:
:)
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Posted by wingsofsong
Posted by 5ofClubs
Ok so this ingredient is only harmful if overdosed on. Isn't that the case with any medicine?
It worked awesome for DD.
I think the issue is that the amount of belladonna in Hyland's was inconsistent, so you never now how much they are getting. That's the case with any drug not approved by the FDA. I know a lot of people have used these and love them, but I try to stay away from anything not FDA regulated for reasons like this.
ITA, I never used them for this reason either.
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| Posted 10/24/10 4:54 PM |
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Momma2Be
Mommy of an angel
Member since 10/09 5911 total posts
Name:
Dina
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Posted by Goobster
Posted by wingsofsong
Posted by 5ofClubs
Ok so this ingredient is only harmful if overdosed on. Isn't that the case with any medicine?
It worked awesome for DD.
I think the issue is that the amount of belladonna in Hyland's was inconsistent, so you never now how much they are getting. That's the case with any drug not approved by the FDA. I know a lot of people have used these and love them, but I try to stay away from anything not FDA regulated for reasons like this.
ITA, I never used them for this reason either.
Me too. I have so many friends that swear by it too. Scary!
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| Posted 10/24/10 10:21 PM |
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mommyIam
Member since 7/09 9209 total posts
Name:
Shana
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
IMO, the reasoning is bogus. The amount is inconsistent because the amount is negligible to nothing. The methods to dilute it, dilute to such a low amount that instruments can't detect it.
DH (a physican) was very concerned about the belladonna, he and our Ped discussed it at depth. Our ped had to explain what homeopathic means to DH. Its not something taught in med school, or in college probably. Anyway our ped said the only real ingredient in it is lactose.
With that said, and my personal feelings are that the product got too popular and the company that makes Orajel probably lobbied for it to be recalled, I probably will be hesitant about using it, just cause I have some faith the FDA isn't a bunch of puppet monkeys.
eta: we looked into it, the gel, is not recalled, has the same ingredients.
FDA says the methods are producing inconsistent batches.
The company hasn't had a recall or report of any problem in its over 100 years of existence.
Message edited 10/24/2010 11:09:44 PM.
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| Posted 10/24/10 10:32 PM |
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nbc188
Best friends!
Member since 12/06 23090 total posts
Name:
C
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
interesting...I need to look into this more, thanks.
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| Posted 10/25/10 8:54 AM |
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lucyloo
nope
Member since 1/06 9758 total posts
Name:
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
My Ped told me to stay away from it so I never used it.
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| Posted 10/25/10 9:07 AM |
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kahlua716
3 Girls for Me!
Member since 8/07 12475 total posts
Name:
Keri
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
How did you ladies know:
a- that it isn't FDA regulated
b- that belladonna is not good?
I remember my aunt using these for my cousins so I bought them for DD. I've only used them a few times, but I never thought about either of the above.
I feel guilty- like I should've known better....
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| Posted 10/29/10 3:54 PM |
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mommyIam
Member since 7/09 9209 total posts
Name:
Shana
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Belladonna is Deadly Nightshade, if you eat the plant its very toxic. But throuout history and even today, extracts from it are used in medicine. Homepathic preperation of it, generally dillutes the extract in lactose or another benign ingedient. But its dilluted so much, that there isn't enough in it to categorize as medicine or drug. You can pick up homeopathic pellets of it, at any kind of health store. Those aren't regulated either.
Read the FDA justification for pulling it, they never say its harmful, only they can't verify exactly the amount of belladonna in it.
And btw, the teething gel has the same belladonna in it, and its not recalled.
Edited because I realize now my understanding for FDA regulation of drugs vs herbs wasn't correct.
Message edited 10/30/2010 8:12:23 AM.
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| Posted 10/29/10 4:25 PM |
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Xelindrya
Mommy's little YouTube Star!
Member since 8/05 14470 total posts
Name:
Veronica
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Posted by mommyIam
IMO, the reasoning is bogus. The amount is inconsistent because the amount is negligible to nothing. The methods to dilute it, dilute to such a low amount that instruments can't detect it.
DH (a physican) was very concerned about the belladonna, he and our Ped discussed it at depth. Our ped had to explain what homeopathic means to DH. Its not something taught in med school, or in college probably. Anyway our ped said the only real ingredient in it is lactose.
With that said, and my personal feelings are that the product got too popular and the company that makes Orajel probably lobbied for it to be recalled, I probably will be hesitant about using it, just cause I have some faith the FDA isn't a bunch of puppet monkeys.
eta: we looked into it, the gel, is not recalled, has the same ingredients.
FDA says the methods are producing inconsistent batches.
The company hasn't had a recall or report of any problem in its over 100 years of existence.
ITA!
Its yet another scare tactic. Inconsistant is a Ridiculously vague description. Its not pure belladonna. And how many tablets are you giving the kid?
AJ used them sucessfully but never more than twice in a day for the limited 2-3 tablets.
This certainly wouldn't stop me from buying them.
#1 its an FDA alert
#2 they voluntarily recalled it (without being told unlike others lately)
#3 anything in great qualities is dangerous
#4 every drug FDA approved or not will have adverse reactions in a % of people with or without large quanities.
I tried them myself before I gave them to AJ there's just no way you can convince me of that itty bitty tiny amount in the correctly suggested dosage under controlled circumstance is the equilivant to bug parts in a child's formula or faulty tylenol.
But to each their own.
If AJ ever needs them again and I decided to give her a lot in a single day I'll know that the belladonna probably played a part.
On a side note, aren't we always reading the labels... why would anyone be surprised that belladonna is in it?
Message edited 10/29/2010 4:42:26 PM.
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| Posted 10/29/10 4:41 PM |
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BabyBeans
LIF Adult
Member since 3/07 930 total posts
Name:
Melissa
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
i bought them from BRU but havent used them yet, do you think they will take them back? but of course i dont have a reciept anymore
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| Posted 10/29/10 6:55 PM |
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Peainapod
Peanuts are here!
Member since 1/09 13591 total posts
Name:
Diana
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Posted by mommyIam
IMO, the reasoning is bogus. The amount is inconsistent because the amount is negligible to nothing. The methods to dilute it, dilute to such a low amount that instruments can't detect it.
DH (a physican) was very concerned about the belladonna, he and our Ped discussed it at depth. Our ped had to explain what homeopathic means to DH. Its not something taught in med school, or in college probably. Anyway our ped said the only real ingredient in it is lactose.
With that said, and my personal feelings are that the product got too popular and the company that makes Orajel probably lobbied for it to be recalled, I probably will be hesitant about using it, just cause I have some faith the FDA isn't a bunch of puppet monkeys.
eta: we looked into it, the gel, is not recalled, has the same ingredients.
FDA says the methods are producing inconsistent batches.
The company hasn't had a recall or report of any problem in its over 100 years of existence.
very valid. I still have gel but tossed the tablets b/c i was freaking out. I should have left it. I've given them to DS and when he was a newborn I used the colic tablets. If he got 2 in day, that was the most he got.
I used the orajel one nite when DS was in a teething fit of pain, and it numbed his throat. he was making the most awful noise from it. I tossed that crap. I think thats worse than what the hylands can do.
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| Posted 10/29/10 7:05 PM |
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eddiesmommy
best buds!
Member since 5/09 11524 total posts
Name:
Melissa
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
its not FDA regulated bc no herbs or supplements are FDA regulated. The only regulation over herb and supplement manufacturing that the FDA has is the standards in which they are produced, cleanliness, etc.
Herb and Supplements are guided by the Good Manufacturing Practices. They are self regulated and have to have extensive research that they are safe and be able to back up any claims that are made.
The claims made by manufacturers in advertising is regulated by the FTC.
The FDA does monitor post marketing complaints and reports of adverse effects, but herbs and supplements do not need to have FDA approval prior to being marketed.
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| Posted 10/29/10 7:06 PM |
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MsMBV
:P
Member since 5/05 28602 total posts
Name:
Me
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Posted by Peainapod
I used the orajel one nite when DS was in a teething fit of pain, and it numbed his throat. he was making the most awful noise from it. I tossed that crap. I think thats worse than what the hylands can do.
My ped hates hates hats orajel...he actually told me that it is one of the most dangerous things on the market for kids. He claims that it can actually cause a child to choke because of the throat numbing from it.
I am wondering why only Hylands. There are other brands as well....what about Humphrey's? It has the same ingredients, no?
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| Posted 10/29/10 11:09 PM |
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lc214
BLUE times 2!
Member since 11/05 1884 total posts
Name:
Christine
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Re: FDA Issues Consumer Safety Alert: Hylands Teething Tablets
Posted by MsMBV
Posted by Peainapod
I used the orajel one nite when DS was in a teething fit of pain, and it numbed his throat. he was making the most awful noise from it. I tossed that crap. I think thats worse than what the hylands can do.
My ped hates hates hats orajel...he actually told me that it is one of the most dangerous things on the market for kids. He claims that it can actually cause a child to choke because of the throat numbing from it.
I am wondering why only Hylands. There are other brands as well....what about Humphrey's? It has the same ingredients, no?
I was wondering the same thing. I checked the Humphreys' website to see if they had the same ingredients. (which, yes they do) So why is there only an FDA warning on Hylands. My ped just suggested to me last week to try them because DS is teething (I had already been using them anyway.) urgh, they had been working so well!
Message edited 10/30/2010 8:01:51 AM.
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| Posted 10/30/10 8:01 AM |
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