PSA: Hyland's Teething Tablets - DON'T use this "homeopathic" product!

[Deb in IA]

FDA:Hyland's Teething Tablets May Pose Risk, Being Recalled By Company

The U.S. Food and Drug Administration late Saturday said it is warning consumers that Hyland's Teething Tablets may pose a risk to children and to dispose of any of the product in their possession.

The agency in a statement also said that, after consultation with the FDA, the manufacturer of the product, Standard Homeopathic Co., agreed to voluntarily recall the tablets from the market.

Hyland's Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses, the agency said. It added that FDA laboratory analysis has found that the product contains inconsistent amounts of belladonna.

Also, the FDA said it has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.

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Hyland’s Teething Tablets: Questions and Answers
Search Consumer Updates

What action is FDA taking?
On October 23, 2010, the Food and Drug Administration (FDA) warned consumers to stop using and discard Hyland’s Teething Tablets. The manufacturer is recalling this product.

Why is FDA taking this action?
FDA is issuing this warning because the use of Hyland’s Teething Tablets may pose a risk to children. FDA analysis and testing identified some Hyland’s Teething Tablets that contained varying amounts of belladonna, a potentially toxic ingredient. FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. An ongoing FDA inspection at the manufacturer indicates substandard control of the manufacturing operation.

FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.

What product is affected by this warning?
FDA is warning consumers about all lots of Hyland’s Teething Tablets. This product is widely sold in pharmacies, other retail stores, and on the Internet as an over-the-counter (OTC) homeopathic drug intended to provide temporary relief of symptoms related to teething in children.

What is belladonna?
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.

What are symptoms of belladonna toxicity or overdose?
Belladonna alkaloids have anticholinergic effects. Classic signs of anticholinergic toxicity include fast heart rate, increased body temperature, dry skin and dry mouth, skin flushing, constipation, decreased urination, agitation, disorientation, hallucinations, and dilated pupils. Drowsiness may also be seen in infants.

Are Hyland’s Teething Tablets approved by the FDA?
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.

What should consumers do if they experience harm related to these products?
FDA recommends that consumers contact their health care professional if their child experiences symptoms after taking Hyland’s Teething Tablets. Symptoms include a depressed level of consciousness, seizure, difficulty or slowed breathing, lethargy, sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation.

Health care professionals and consumers should report side effects from use of Hyland’s teething tablets to FDA through the MedWatch program, by phone at 1-800-332-1088, or online at http://www.fda.gov/medwatch/index.html4

What steps is the FDA taking?
FDA issued a consumer advisory warning consumers to stop using and discard or return the Hyland’s Teething Tablet product. The agency’s investigation of the product and the firm’s manufacturing operations is ongoing.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.


http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm230762.htm

 

[sbell111]

That's too bad. That product really helped Pincess Wigglypants.

 

[golfgal]

I am amazed by the number of people that think "homeopathic" automatically means "safe". Most medications on the market have their roots in herbals yet people will take anything listed as an "herbal" or "homeopathic".

 

[Green Tea]

Great warning.

 

[npmommie]

There is nothing wrong with using homeopathic remedies, but I think the companies producing these have an obligation to maintain strict manufacturing, and ensure the product has consistent amounts, especially when it contains something potentially dangerous.
I also think parents have the responsibility to use it properly, understand what it is, and store it properly out of reach of children.
any type of vitamin, medicine, herbal remedy etc should be locked away from kids always.

 

[minkydog]

I am amazed by the number of people that think "homeopathic" automatically means "safe". Most medications on the market have their roots in herbals yet people will take anything listed as an "herbal" or "homeopathic".

Me too. Chemicals are chemicals. It doesn't matter if you get them out of your foxglove plants or out of a prescription bottle. At least with FDA approval you there are standards applied and that there has been at least *some* kind of testing done before being released on the public.

 

[cm8]

FDA:Hyland's Teething Tablets May Pose Risk, Being Recalled By Company

The U.S. Food and Drug Administration late Saturday said it is warning consumers that Hyland's Teething Tablets may pose a risk to children and to dispose of any of the product in their possession.

The agency in a statement also said that, after consultation with the FDA, the manufacturer of the product, Standard Homeopathic Co., agreed to voluntarily recall the tablets from the market.

Hyland's Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses, the agency said. It added that FDA laboratory analysis has found that the product contains inconsistent amounts of belladonna.

Also, the FDA said it has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.

----------------------------------------------------------------------
Hyland’s Teething Tablets: Questions and Answers
Search Consumer Updates

What action is FDA taking?
On October 23, 2010, the Food and Drug Administration (FDA) warned consumers to stop using and discard Hyland’s Teething Tablets. The manufacturer is recalling this product.

Why is FDA taking this action?
FDA is issuing this warning because the use of Hyland’s Teething Tablets may pose a risk to children. FDA analysis and testing identified some Hyland’s Teething Tablets that contained varying amounts of belladonna, a potentially toxic ingredient. FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. An ongoing FDA inspection at the manufacturer indicates substandard control of the manufacturing operation.

FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.

What product is affected by this warning?
FDA is warning consumers about all lots of Hyland’s Teething Tablets. This product is widely sold in pharmacies, other retail stores, and on the Internet as an over-the-counter (OTC) homeopathic drug intended to provide temporary relief of symptoms related to teething in children.

What is belladonna?
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.

What are symptoms of belladonna toxicity or overdose?
Belladonna alkaloids have anticholinergic effects. Classic signs of anticholinergic toxicity include fast heart rate, increased body temperature, dry skin and dry mouth, skin flushing, constipation, decreased urination, agitation, disorientation, hallucinations, and dilated pupils. Drowsiness may also be seen in infants.

Are Hyland’s Teething Tablets approved by the FDA?
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.

What should consumers do if they experience harm related to these products?
FDA recommends that consumers contact their health care professional if their child experiences symptoms after taking Hyland’s Teething Tablets. Symptoms include a depressed level of consciousness, seizure, difficulty or slowed breathing, lethargy, sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation.

Health care professionals and consumers should report side effects from use of Hyland’s teething tablets to FDA through the MedWatch program, by phone at 1-800-332-1088, or online at http://www.fda.gov/medwatch/index.html4

What steps is the FDA taking?
FDA issued a consumer advisory warning consumers to stop using and discard or return the Hyland’s Teething Tablet product. The agency’s investigation of the product and the firm’s manufacturing operations is ongoing.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.


http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm230762.htm

Thanks for the info!

 

[harleyquinn]

Ugh. Call me stupid, but I totally don't care/think about the homeopathicness. It's the only thing that remotely works for my child. I take it something billed as homeopathic has fewer regulations to go through or something?

I am so tired of companies putting crap out that has to be recalled.

FWIW it always bugged me that the cap was so easy to turn.

 

[bumbershoot]

There is nothing wrong with using homeopathic remedies, but I think the companies producing these have an obligation to maintain strict manufacturing, and ensure the product has consistent amounts, especially when it contains something potentially dangerous.
I also think parents have the responsibility to use it properly, understand what it is, and store it properly out of reach of children.
any type of vitamin, medicine, herbal remedy etc should be locked away from kids always.

I agree.


However, it's interesting that there were inconsistent amounts, b/c the POINT of homeopathy is that there is NO MEASURABLE amount in it AT ALL.

So IF they found some, that's a sign that Hylands is having a problem.


That said, if you take too much of a remedy, you can "prove" it. For example, DS once got to the Boiron tube of chamomile. As far as I could tell, he was gnawing on it and drooling (teething) into it, and it liquified the pellets and he drank it. How he did this while I was a room away doing laundry I don't know, but he did.

And I couldn't use the remedy for upwards of a year, because after that, chamomile would amp him up, not calm him down.


I personally gave up on Hylands b/c the "shotgun" approach isn't appropriate for homeopathy. It's best to use the ONE remedy that matches the specific symptoms at that moment the best. There were teething times when Hylands didn't work, but taking just ONE of the remedies already in it did work. And generally for DS that was the belladonna mentioned (again, in homeopathy, it is "succussed" so many times that there's not to be a measurable amount at all), b/c his symptoms generally matched it (bright red cheeks were the main sign that I recall).


Now, in a different statement than the news article had...hylands says:

Adverse events have been reported but the FDA has said that a conclusive link has not been determined.

Took quite a bit of work to get to the site since it appears the universe is trying to get to it all at once, but:

Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland’s Teething Tablets to Address Manufacturing Process

Los Angeles, October 23, 2010 – Standard Homeopathic Company, in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling its Hyland’s Teething Tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility. Hyland’s Teething Tablets are manufactured in the United States and distributed throughout North America.

The Hyland’s Teething Tablets UPC codes included in the recall are:

1. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
2. Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
3. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
4. Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
5. Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
6. Hyland’s Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109

Adverse events have been reported but the FDA has said that a conclusive link has not been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hyland’s Teething Tablets have a wide margin of safety that protects consumers from harm.

After in-depth analysis, a comprehensive review of the company’s adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland’s Teething Tablets are safe for infants and toddlers.

In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Company will continue to closely monitor and evaluate the situation and consult with FDA.

Consumers that are concerned about the safety of the product may contact Standard Homeopathic Company for instructions on a refund or replacement product. For these instructions or information regarding how to return or dispose of the product, consumers should log on to www.hylandsteething.com/recall or call 1-877-496-5044 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).

“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” said Mark Phillips, PharmD, President and Chief Pharmacist of Standard Homeopathic Company. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”

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.

No other Standard Homeopathic Company products are affected by this recall.

Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

With over 100 years of experience in providing families with access to safe, natural, reliable medicines, Standard Homeopathic Company and its division, Hyland’s, Inc., have many symptom fighting products consumers have come to trust. For more information on their line of products, visit www.hylands.com or www.facebook.com/Hylands.Health.

About Standard Homeopathic Company

Standard Homeopathic Company develops and manufacturers lines of homeopathic medicines, including its top-selling Hyland’s brand. Hyland’s homeopathic formulas are manufactured with the highest quality natural ingredients following the strictest standards of preparation. With over a century of commitment, Standard Homeopathic Company’s tradition of excellence consistently provides quality and integrity in every product. From Hyland’s Teething Tablets to Hyland’s Calms Forté, Standard Homeopathic Company cares for your family at every stage of life. Consumers can trust Standard Homeopathic Company’s products to be natural, gentle, effective and safe for the entire family.

 

[harleyquinn]

Thanks for that info bumbershoot.

Ever since the sling recall put really good, quality companies out of business, I've been hesitant to fall in line to a recall without more information.

 

[Polyluvr]

I am amazed by the number of people that think "homeopathic" automatically means "safe". Most medications on the market have their roots in herbals yet people will take anything listed as an "herbal" or "homeopathic".

ITA!!!

I alwsas stuck w what my Mom and our pediatrician told us~ dip your finger in a whiskey botlle and rub on the gums~ always worked~ and how much booze was actually on your finger anyway???

I wouldn't give my cat a homeopathic drug~ let alone my kids

 

[golfgal]

Ugh. Call me stupid, but I totally don't care/think about the homeopathicness. It's the only thing that remotely works for my child. I take it something billed as homeopathic has fewer regulations to go through or something?

I am so tired of companies putting crap out that has to be recalled.

FWIW it always bugged me that the cap was so easy to turn.

They have NO regulations to go through-that is the problem.

 

[minkydog]

ITA!!!

I always stuck w what my Mom and our pediatrician told us~ dip your finger in a whiskey bottle and rub on the gums~ always worked~ and how much booze was actually on your finger anyway???

I did that too, in desperation. Usually a little tylenol did the trick but every now and then...let's just say Capt Morgan is your friend...