Thursday, October 28, 2010

Hylands Teething Tablets Recall

Yes, I had these in my medicine cabinet and had to throw them away!

Direct from the FDA.gov website - Here are the details:


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.html

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.
Posted: October 24, 2010

2 comments:

Anonymous said...

It may be good to read the "other side" of this story... notice that the reason the FDA has asked for a recall is because of the belladonna content, but as is stated in the following article, "Many pharmaceuticals utilize a Belladonna derivative, atropine, as an antispasmodic. A typical potency is 0.4 - 0.8 milligrams per pill(1). In this form, it can be effective, but it also carries serious risks. In contrast, the amount of Belladonna in the Hyland's formulation is a mere 0.0002 milligrams per pill. A single pill of the pharmacy formulation is 2,000 to 4,000 times stronger!"

http://gaia-health.com/articles301/000321-fda-bans-hylands-homeopathic-teething-product.shtml

It is totally up to you as to whether or not you toss your tablets, but as for me, as long as I can get them (I'm in Canada and the recall has not applied to our shelves... yet), I will continue to give them to my children as a safe and effective way to combat teething pain.

Kaspars said...

i can recommend these. our daughter was an absolute nightmare with her teeth until we tried this. she has been wearing it since she was 8 months old and we haven't looked back since. i never take hers off, she sleeps with it on too. i have heard from a few people that take their lo's necklaces off at night and they all say that they still get sleepless nights due to teething. i think that they should be worn 24hrs a day. i feel quite happy that they are not a choking hazard. the necklace has a low breaking strain so if it had to get caught on something(an unlikely occurence) then it would snap. if it were to snap for any reason, each bead has been double knotted on, so that they wouldn't all fall off. i got mine off an Latvian Amber Store. it was $10.50, so not expensive at all.
http://www.latvianamberstore.com/en/Baltic_Amber_for_Children/Polished_Amber_Teething_Necklaces