Hyland's teething tablets recall

[lalemma]

I searched and didn't see this already posted...

Hyland's statement.

FDA release:

Hyland’s Teething Tablets: Recall - Risk of Harm to Children

AUDIENCE: Consumers, Pediatrics

ISSUE: FDA notified consumers that Hyland’s Teething Tablets is being recalled because the tablets may pose a risk to children. The 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 has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna.

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.

BACKGROUND: Hyland’s Teething Tablets is a homeopathic product, intended to provide temporary relief of teething symptoms in children. It 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.

RECOMMENDATION: FDA recommends that consumers not use this product and dispose of any in their possession. 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.

[Lauren31]

Thanks! We are affected by it! Luckily the baby is ok

[karika]

I heard of the recall on FB. I am not convinced it is anything to worry about. I feel it is most likely part of the ploy by the pharma controlled FDA to pave the way for outlawing herbs and plants as remedies. Unless of course they are patented and created by pharma, who would taint them with chemicals and not make them correctly (ie use the whole plant in a remedy that should be only the roots...) I will get my coupon for replacement product just because as a parent it is better to err on the side of safety, but I smell a rat here. A big fat one that likes to line its pockets with profits and is determined to close down all opposition.

[lalemma]

We don't use homeopathics, but we DO use herbal remedies, and Belladonna is something I take very, very seriously. I would NEVER use it for a child unless under the guidance of a very experienced herbalist.

If a company is telling me that there are no appreciable levels of Belladonna in their product, because it's a homeopathic, but in actuality the levels of Belladonna vary - I would want to know. I don't consider that some kind of wacky FDA ploy.

Just because it's natural doesn't mean it cannot cause harm.

Lauren - glad baby is okay.

[~Demeter~]

Homeopathics and herbal remedies are two very different things.... very different.

That said I'm pretty sure you'd need to take an awful lot of teething tablets to be adversely effected... I know more than one post on this board where a little one has accidentally got into a bottle of teething tablets and when mom called poison control was told they'd essentially need to eat the whole bottle or numerous bottles.

So I'm kind of left wondering what exactly is going on here. :/

[tzs]

i believe it. my friend's mom is a crunchy ped and had a case of belladonna overdose from hylands.....red flushed skin, pupils as big as saucers....

i use hylands but very sparingly. i like a little regulation in meds.

[chattyprincess]

well I am glad they are recalling for product safety reasons, there should not be varying levels in each tab...they should all be the same, just like the company claims. That being said lets not fail to remember the huge tylenol recalls in the past as well as all of the other "otc" meds that are recalled for contamination reasons, etc.Also food recalls as well, peanut butter, spinach etc. Just because a product is recalled does not mean it is bad it just means that there was something wrong with it at that moment and thankfully someone caught it.
I do have to say that I find the very idea of someone overdosing on belladonna through teething tabs a bit questionable. I find the fact that these "overdose" reports are not backed by blood tests from the children very questionable. This is my biggest problem with claimed overdoses of anything, you cannot know unless you are doing a true blood test.
Hyland's Teething Tablets Safety Information

As a manufacturer of homeopathic medicines, and as parents ourselves, we want to share with you how Hyland’s Teething Tablets are made and what they contain to effectively and safely alleviate your child’s teething aches and pains.

First and foremost, homeopathic medicines are regulated as drugs by the Food and Drug Administration (FDA), as required in the Food, Drug and Cosmetic Act. The production of Hyland’s homeopathic medicines occurs within a validated process, as with any FDA-regulated drug, to ensure an accepted level of consistency in product output.

Hyland’s Teething Tablets contain homeopathically prepared forms of Calcarea Phosphorica, Chamomilla, Coffea Cruda, and Belladonna. These ingredients are all prepared in accordance with the Homeopathic Pharmacopœia of the United States (HPUS). HPUS has been recognized by the FDA since 1938 as the official compendium (or formula book) for homeopathic medicine in the U.S. When homeopathically prepared, active ingredients are diluted to the point that the risk of toxicity is extremely low (see specific details below).

Calcarea Phosphorica is included in Hyland’s Teething Tablets for its ability to support teeth formation. Chamomilla is included in the Tablets for its actions on irritability commonly associated with teething pain. Coffea Cruda is included in the Tablets for its actions on wakefulness and increased urination.

Belladonna is included in the Tablets to ease the redness, inflammation and discomfort of the child’s gum that often occurs during the teething process. Belladonna 3X HPUS is manufactured from the whole plant, of which a small portion is Belladonna alkaloids (the component sometimes associated with side effects). Each Teething Tablet (which weighs about 65 mg) is composed of 0.0003% Belladonna alkaloids as stated on the label. This means that each complete teething tablet contains only approximately 0.0002 mg of Belladonna alkaloids.

The amount of Belladonna alkaloids in teething tablets is minuscule, especially when compared to conventional medicine. Conventional medicines typically use 0.2 to 5 mg of Belladonna alkaloids per tablet as an anti-spasmodic – roughly 1,000 to 25,000 times larger than the quantities used in Hyland’s Teething Tablets. The side effects sometimes caused by conventional medicines delivering more than 0.2 mg of Belladonna alkaloids – such as dry mouth, blurred vision and urinary retention – are not associated with homeopathic medicines because of their minute dosage.

To put homeopathic dosages in perspective, typically a 10-pound child would need to ingest 1,000 Hyland’s Teething Tablets (at least 6 bottles of 125 tablets) to exhibit even the first possible side effect of Belladonna.

Hyland’s Teething Tablets have been safely used by millions of children since being introduced to the U.S. market in 1945! Click here to see what actual parents have to say about Hyland’s Teething Tablets.

We care about your child and our consumers’ safety is our #1 priority. For that reason, we have pharmacists available around the clock (24 hours per day, 7 days per week) to provide emergency information related to any of our products. You can contact us at 1-800-624-9659 (number also available on all packaging). We are confident that our pharmacist can help parents and their doctors reach informed conclusions regarding our products.

Please keep in mind that even if a child ate an entire bottle of homeopathic medicine, the minute amount of active ingredients renders an overdose unlikely. Nonetheless, we understand that parents are rightfully cautious about their own child so feel free to call us anytime if you are concerned.

While adverse symptoms that may be attributed to an overdose of Belladonna alkaloids are well documented in the literature, the concentration necessary would require the ingestion of multiple bottles of Teething Tablets. As this is very unlikely, such symptoms could be due to any of a number of other causes (click here for more causes that could be explored).

We at Hyland’s, Inc. greatly value our relationship with the consumers who make up our Hyland’s family. Please do not hesitate to call 1-800-624-9659 and ask for our on-staff pharmacist to receive any additional information.

Iris R. Bell, MD PhD

Director of Scientific Affairs
http://www.hylands.com/news/teethinginfo.php
(obviously this does not mean that the tabs right now are safe, there is obviously been a problem with them during manufacturing, however I do find the information stated here helpful in truly understanding the belladonna in the HOMEOPATHIC (not herbal) remedy of hylands teething tabs.

[karika]

Originally Posted by chattyprincess

I do have to say that I find the very idea of someone overdosing on belladonna through teething tabs a bit questionable. I find the fact that these "overdose" reports are not backed by blood tests from the children very questionable. This is my biggest problem with claimed overdoses of anything, you cannot know unless you are doing a true blood test.
Hyland's Teething Tablets Safety Information


Belladonna is included in the Tablets to ease the redness, inflammation and discomfort of the child’s gum that often occurs during the teething process. Belladonna 3X HPUS is manufactured from the whole plant, of which a small portion is Belladonna alkaloids (the component sometimes associated with side effects). Each Teething Tablet (which weighs about 65 mg) is composed of 0.0003% Belladonna alkaloids as stated on the label. This means that each complete teething tablet contains only approximately 0.0002 mg of Belladonna alkaloids.

The amount of Belladonna alkaloids in teething tablets is minuscule, especially when compared to conventional medicine. Conventional medicines typically use 0.2 to 5 mg of Belladonna alkaloids per tablet as an anti-spasmodic – roughly 1,000 to 25,000 times larger than the quantities used in Hyland’s Teething Tablets. The side effects sometimes caused by conventional medicines delivering more than 0.2 mg of Belladonna alkaloids – such as dry mouth, blurred vision and urinary retention – are not associated with homeopathic medicines because of their minute dosage.

To put homeopathic dosages in perspective, typically a 10-pound child would need to ingest 1,000 Hyland’s Teething Tablets (at least 6 bottles of 125 tablets) to exhibit even the first possible side effect of Belladonna.

Thank you for posting this. I find it helpful in understanding.

[Adaline'sMama]

Since the Tylenol recall, I have been terrified to give DD anything (not that I ever gave her tylenol, just as a point). It is really scary that even something as (what I thought was) harmless as Hylands could need a recall.

[lalemma]

Originally Posted by ~Demeter~

Homeopathics and herbal remedies are two very different things.... very different.

That said I'm pretty sure you'd need to take an awful lot of teething tablets to be adversely effected... /

Yes, with an actually homeopathic remedy, I'm sure this is true. The problem here, as I see it, is that Hyland's is claiming to sell homeopathic pills (containing negligible amounts of Belladonna) but may actually, due to the manufacturing process, periodically be selling pills that are not homeopathic but instead herbal (containing appreciable amounts of Belladonna.)

I am as skeptical of the FDA being in bed with Big Pharma as anyone. However, I really wish that supplements were at least somewhat regulated.

[Hannah32]

Thanks for the info. We'll be getting a replacement. Sam hasn't had very many of these, but I do use them occasionally when he's really cranky and drooling a lot. I was interested in the chamomile, didn't pay attention to the rest.

[chattyprincess]

Originally Posted by lalemma

I am as skeptical of the FDA being in bed with Big Pharma as anyone. However, I really wish that supplements were at least somewhat regulated.

First and foremost, homeopathic medicines are regulated as drugs by the Food and Drug Administration (FDA), as required in the Food, Drug and Cosmetic Act. The production of Hyland’s homeopathic medicines occurs within a validated process, as with any FDA-regulated drug, to ensure an accepted level of consistency in product output.

Hyland’s Teething Tablets contain homeopathically prepared forms of Calcarea Phosphorica, Chamomilla, Coffea Cruda, and Belladonna. These ingredients are all prepared in accordance with the Homeopathic Pharmacopœia of the United States (HPUS). HPUS has been recognized by the FDA since 1938 as the official compendium (or formula book) for homeopathic medicine in the U.S. When homeopathically prepared, active ingredients are diluted to the point that the risk of toxicity is extremely low

[Sfcmama]

Originally Posted by Hannah32

Thanks for the info. We'll be getting a replacement. Sam hasn't had very many of these, but I do use them occasionally when he's really cranky and drooling a lot. I was interested in the chamomile, didn't pay attention to the rest.

How do you get a replacement? I looked on the hylands website but didn't see it. It's probably obvious and I'm just too tired to see it ;0) TIA

[flower01]

Originally Posted by Sfcmama

How do you get a replacement? I looked on the hylands website but didn't see it. It's probably obvious and I'm just too tired to see it ;0) TIA

Thanks for the info. But, I am confused as well. Is it just certain bottles that are no good. We are using some right now and I'd like to know what i'm looking for if I should get a replacement.

[flower01]

Originally Posted by flower01

Thanks for the info. But, I am confused as well. Is it just certain bottles that are no good. We are using some right now and I'd like to know what i'm looking for if I should get a replacement.

Nevermind...the link in OP went straight to the codes.

[northerngirl]

I have some these, but not sure if they're included in the recall. I do not have the original packaging, which would have the upc number. The only number I see on the bottle is a 6 digit number. Is this not what I'm looking for? TIA

[sammymama]

This link from Hyland's has the UPC numbers of the affected bottles listed. That said, my number actually says UDC in front of it instead of UPC, go figure! It is listed on my bottle on the front, right above the Hyland's logo. For replacements or refunds all they say is to log onto this site or call their 800 number for more info:

http://www.hylands.com/news/hylands-teething-recall.php

I am torn on this one as DD *looooves* these; as she's currently cutting 4 teeth she's been "popping" a few every night before bed lately. She's had no issues but I feel like a bad mama giving her something that is being recalled...

[Sayward]

Holy crap I stopped using these last week because they were making Waits throw up. For fucks sake, I'm SO paranoid and careful about what I give him, of course the ONE thing I choose, the seemingly innocuous homeopathy (I don't even friggin' BELIEVE in homeopathy!), is the one that gets recalled. yeesh . . .

So vomiting wasn't on the list of symptoms, but could excessive belladonna have caused this? It's been a week and he's fine; do you think I need to worry?

[lookatreestar]

Originally Posted by Sayward

Holy crap I stopped using these last week because they were making Waits throw up. For fucks sake, I'm SO paranoid and careful about what I give him, of course the ONE thing I choose, the seemingly innocuous homeopathy (I don't even friggin' BELIEVE in homeopathy!), is the one that gets recalled. yeesh . . .

So vomiting wasn't on the list of symptoms, but could excessive belladonna have caused this? It's been a week and he's fine; do you think I need to worry?

the lactose in them always made my dd spit the tablets up.

[bizzylizzy]

So here's the webpage to do the refund/coupon:

http://www.hylandsteething.com/recall/notify.php

But I have no idea where to find the NDC# and Lot# on the bottle. Ideas?