Over the weekend, Standard Homeopathic Company issued a voluntary recall of all Hyland’s Teething Tablets “in an abundance of caution due to an FDA investigation of its manufacturing facility”. The company’s press release indicates that
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…
In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols.
A little vague, don’t you think? The FDA’s press release which followed provides more information, highlighting two major concerns:
(1) Testing of the company’s product showed inconsistent levels of belladonna, which can be toxic in large doses. The FDA has received reports of serious adverse events in children taking the product that are consistent with belladonna toxicity.
(2) The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have childproof caps.
While the company’s recall lists specific UPC#’s included in the recall, there’s no need to check the UPC because all Hyland’s teething tablets are subject to the recall. The FDA has recommended that consumers stop using the product immediately and dispose of any in your possession. I nearly bought this product last week for my teething infant because I’d heard the benefits touted by some of my other mom friends who’ve used it, but ultimately I decided against it until I had an opportunity to do some more research on the ingredients. I’m glad I waited.
Belladonna, otherwise known as Deadly Nightshade, is a poisonous plant which can be fatal in large doses and, according to this article published in the Encyclopedia of Alternative Medicine, can be toxic even in small doses and should always be taken under the direction of a doctor. Belladonna alkaloids, the active ingredient of the plant which make it toxic, are the very same ingredient used in homeopathic remedies to treat various illnesses and symptoms including seizures, fever, acute pain, restlessness, and inflammation among others.
According to the Hyland Teething Tablet Fact Sheet, belladonna is included in the tablets to ease inflammation and discomfort of the child’s gums. It is manufactured from the whole plant, of which a small portion is Belladonna alkaloids. The Fact Sheet goes on to assure consumers of its safety and miniscule dosage level; however, the article I previously referred to states that “some patients experience toxicity at unusually low doses”. The alkaloids work by blocking certain nerve impulses in the parasympathetic nervous system which regulates certain involuntary bodily functions. Symptoms of belladonna toxicity or overdose include extreme restlessness, seizures, fast heart rate, increased body temperature, dry skin and dry mouth, skin flushing, constipation, decreased urination, disorientation, hallucinations, and dilated pupils. According to the FDA’s FAQ on the recall, drowsiness may also be seen in infants. The FDA urges anyone who experiences these symptoms to contact their doctor and report the side effects to the FDA through the MedWatch program, by phone at 1-800-332-1088, or online at http://www.fda.gov/medwatch/index.html.
Each article I read about belladonna regards it as something not to be messed with. The FDA itself indicated that its use needs to be “carefully controlled” which is why the Standard Homeopathic Company’s substandard manufacturing control process is of such concern. Honestly, even once the Company gets its act together, I don’t think I’d be comfortable giving this or any other product containing belladonna to my child unless prescribed by a doctor.
Another safety concern that should be noted, last month a medical alert was issued warning of infant botulism cases linked to consumption of homeopathic teething products containing chamomile (Hyland’s was not named, but the product does contain chamomile). Apparently, dried chamomile can contain trace amounts of botulism which are perfectly tolerable for adults and older children but may be concentrated enough to harm young infants. Rumor has it Hyland’s is currently under investigation for this as well.
-Jasmine
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