One of the nation’s largest homeopathy companies announced Thursday that it was recalling all of its infant teething tablets at the request of US regulators, following reports that the tablets had caused seizures and other severe complications in hundreds of infants.
The company, Standard Homeopathic, said it was recalling the tablets at the request of the Food and Drug Administration, which had concluded that they contained inconsistent amounts of belladonna, an herb known colloquially as “deadly nightshade.”
In diluted form, the substance was not expected to pose any health risk. But over a 10-year period, from 2006 to 2016, the FDA collected reports of “adverse events” in hundreds of infants who had been given the product, according to a STAT investigation. Some became delirious; others had to be rushed to the hospital after their legs and arms began twitching.
Following a warning from the FDA in September, Hyland’s, a subsidiary of Standard Homeopathic, said that it would no longer manufacture the teething products. But the company insisted that the agency had failed to show a scientific link between the teething tablets and infant seizures. The products remained on some store shelves for months, and were still available on the internet.
Under the recall announced Thursday, the company will notify distributors and retailers and arrange for the return of all the products.
In a statement, Hyland’s said it was a “very difficult decision.”
“It is important for you to know that all manufactured and sold teething medicines met the Company’s safety limit tests and all tested product has been well within an established safety threshold,” the company said in a statement. “With this recall, Hyland’s is adhering to what its regulating agency has formally requested.”
The FDA says any homeopathic teething tablets containing belladonna pose “an unnecessary risk” and urges consumers not to use them.
Jennifer R, you’re right this is all about big pharma. It’s a well known fact that the FDA is staffed by drug company executives and that there’s a revolving door between the FDA and big pharma.
The FDA has produced no evidence that teething tablets had anything to do with the negative events or deaths in question. All they present are claims made by parents such as “I gave my child a teething tablet, and he had seizures.” There is no medical evidence to support the conclusion that the tablet was responsible. Since the levels of belladonna the FDA found in its own analysis fall well within the safety limit it would be impossible to assert the tablets could be responsible. If any cases come to court, the lawyers will have to prove the tablets were responsible which will be impossible.
Christine
Perhaps one day you’ll show some understanding of what the precautionary principle is all about, what QA and production SPC are, what benefit vs harm considerations tell us and some concern fo the babies. I’m not holding my breath, though.
Oh! And irony.
On the contrary, the company overseas knew children’s suffered from neurological issues for years. The conducted research in which children were rushed to hospitals with leg spasms. Some had had full blown seizures. When this one item was removed or eliminated they stopped? They knew this for at least 5 years. The major chemical is know with a nickname of “death”. No ethics or moral……I’m a special ed teacher, and see lasting effects.
“But the company insisted that the agency had failed to show a scientific link between the teething tablets and infant seizures.”
Damn. I just spilt my tea laughing.
I know. But homeopaths don’t seem to understand irony. Or science.
What can you say about a group who are happy to be exempted from the usual medicine requirements because their treatments do nothing (except when they get the manufacturing wrong), but then claim that their treatments are effective.
Hyland’s is not recalling this product because it poses even an iota of risk. The company is showing good faith. The FDA conducted an analysis of the teething tablets and found some contained no trace of belladonna at all, that some samples contained amounts below the level of quantification and that some samples contained amounts of belladonna ranging from 0.1 to 53.4 nano-grams. That is, those samples contained from 0.1 to 53.4 millionths of a gram of substance. Obviously this could not possibly harm anyone. All the FDA is saying is that some samples contained amounts of substance which were different from what the label states. That is a far cry from amounts which could be harmful.
The “skeptics” of homeopathy, however, grasp the FDA’s statement and use it to claim that it’s proof that homeopathic teething tablets should not be used.
https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm538669.htm
Christine
I see you still don’t understood sampling and QA. Or what a nanogram is.
However, you said:
“The company is showing good faith.”
Why did it take them six months to show this purported ‘good faith’?
I’m somewhat mystified how homeopaths can both believe that extreme dilutions may cause extreme health improvements but not extreme adverse events.
One point for Christine. If QA is poor there are likely occasional tablets with much higher dosages. Any pharmaceutical company would perform regular sampling and if the dose was outside limits they throw the entire batch away.
Ken, the results of the analysis fall well within the safety range. Therefore, there is no reason to dispose of the batches in question. If you had learned a little bit about homeopathy, you would know that homeopathy uses tiny amounts of substance — often less than a molecule — and works by presenting to the person’s immune system a picture of the symptoms they are experiencing. This triggers the immune system to heal the person naturally. This is what makes homeopathy so effective. Conventional drugs, OTOH, simply mask the symptoms. Because they contain large amounts of substance they create iatrogenic diseases. Homeopathy is safe because it does not contain large amounts of substance.
As I’ve already pointed out to you Christine, you do not understand sampling or process control, nor, it seems, the precautionary principle.
But please tell us what ‘less than a molecule’ means…
The point of QA is to make sure that every tablet is safe. What any manufacturer aims for is to keep the samples within the variability that they expect if everything is working properly, because if it is not then something is not being done correctly and things may occasionally go very wrong. A company in Australia made tablets to stop people falling asleep, I think they contained caffeine, and some people became very high. They hadn’t been testing properly and one of the staff wasn’t running the mixer long enough to obtain an even distribution.
How many people have died from using these teething tablets? How many people have died from using prescription pain pills? This is all about big pharma and who makes the profits. It has nothing to do with public safety.
Jennifer R said:
“How many people have died from using these teething tablets? How many people have died from using prescription pain pills? This is all about big pharma and who makes the profits. It has nothing to do with public safety.”
Let me see if I understand what you’re getting at: some people have died after taking conventional pain medication, so a few babies dying after taking homeopathic teething products don’t matter? Is that what you mean? If not, what?
Oh! By the way, did you know that Hyland’s – or any other manufacturer of homeopathic products – don’t give their products away for free.
ZERO babies have died from the use of this teething product. We are in the midst of an opiate epidemic in the U.S. where an increasing number of people are dying every single day. Refrigerator trucks are being brought in to some locations to handle the number of bodies from overdoses. Purdue Pharma lied about the addictiveness of Oxycontin. Do tell me about the precautionary principle.
Jennifer R said:
“ZERO babies have died from the use of this teething product.”
Well, that’s a very interesting assertion by you. The FDA certainly haven’t said that so I have to wonder why it is you claim that and seem so adamant about it. Are you privy to information not available to the rest of us?
You do have to wonder why Hylands took six months to comply with the FDA’s request to recall the products. Raritan Pharmaceuticals managed to issue a recall in November last year. You have to wonder whose interests Hylands/Standard Homeopathic have at heart: the public’s or their own.